{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2929-s0", "verdict_number": "2929", "title": "MVA85A booster × Added tuberculosis prevention after BCG — Evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Healthy infants already vaccinated with BCG; distinguish the original 2797 participants from the tuberculosis denominators 1399/1395", "intervention": "Addition of the original MVA85A candidate booster after BCG in both groups; no instruction on vaccine selection or use", "dose": null, "comparator": "MVA85A versus placebo after BCG; separate from first BCG vaccination, an unvaccinated control or treatment of established disease", "endpoint": "Original tuberculosis incidence 32/1399 versus 39/1395; efficacy 17.3% (CI −31.9~48.2); infection and immune-response values remain unverified", "duration": "Follow-up up to 37 months; no extension to the same fixed duration for everyone or lifelong prevention", "excluded_extensions": [ "Applying the added MVA candidate result to BCG itself, unvaccinated children or the effects of all boosters or vaccines", "Calculating new totals, missing counts, denominators, rates, absolute differences, effects, CIs, NNTs or individual protection probabilities from 2797 and 1399/1395", "Applying disease-incidence results to tuberculosis infection, test conversion, immune responses or confirmed prevention, or filling in new definitions", "Changing follow-up up to 37 months to the same duration for everyone, person-time, annualized rates, lifelong effects or effects in other populations", "Applying efficacy 17.3/CI −31.9~48.2 and the original finding of no significant benefit to an exact effect of 0, equivalence, exclusion of all important benefits or overall safety", "Creating direct trials or replicated effects of added MVA from 1245 first BCG vaccination B64 or 2743 shortened treatment of established disease C56", "Changing local 89/45, systemic 80/76 and serious 18/18 events or the absence of related serious events to one safety rate or difference, zero risk or individual suitability", "Extending mixed funding, commercial rights or I1 to free products, individual employees, COI, full decision-making authority or certification of independence", "Using the original wording about Korean BCG policy as confirmation of current policy or guidance on vaccine selection, vaccination, route, dose or treatment", "Adding references to the same report, trial, population, group, time point, sibling question or manuscript as new independent trials or total participants", "Inheriting the parent score or axes, historical cross-checks, original-paper review or existing cross-citation checks as subclaim values, current content review or external reading", "New searches or APIs, numerical calculations, hypothetical values, new effects, CIs or grades, certification of independence, or guidance on antibiotic or vaccine selection, use, suitability or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the subclaim and parent values for added protection after BCG?", "needed": "Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes", "role": "Required", "role_reason": "An item prepared to distinguish Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is 'added tuberculosis prevention after BCG', with D grade and the note 'There was no significant benefit'. Parent D34, Caution and original H/R1/I1/E0/B1/C0 axes are parent context; the subclaim has no score, status or axes.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but No new vaccine grade or score is created, and parent values are not inherited. Review of existing content remains incomplete.", "missingness": "No new vaccine grade or score is created, and parent values are not inherited.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes." }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were participants studied before BCG vaccination or as already vaccinated infants?", "needed": "Healthy, already vaccinated infants and the actual selection, age and setting boundaries", "role": "Required", "role_reason": "An item prepared to distinguish Healthy, already vaccinated infants and the actual selection, age and setting boundaries and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Healthy, already vaccinated infants and the actual selection, age and setting boundaries must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Healthy, already vaccinated infants and the actual selection, age and setting boundaries as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original condition is a study of healthy infants who had all already received BCG. It is not extended to unvaccinated children, adults, other immune states or all infants.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified. Review of existing content remains incomplete.", "missingness": "Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Healthy, already vaccinated infants and the actual selection, age and setting boundaries." }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are added MVA85A and the effect of BCG itself the same question?", "needed": "BCG in both groups, the added candidate effect and comparison with placebo", "role": "Required", "role_reason": "An item prepared to distinguish BCG in both groups, the added candidate effect and comparison with placebo and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for BCG in both groups, the added candidate effect and comparison with placebo must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking BCG in both groups, the added candidate effect and comparison with placebo as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original comparison is an MVA85A booster added after BCG versus placebo. It is not changed to efficacy of first BCG vaccination, an unvaccinated control, replacement of BCG or effects of all boosters.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified. Review of existing content remains incomplete.", "missingness": "Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for BCG in both groups, the added candidate effect and comparison with placebo." }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What research condition defines MVA85A?", "needed": "Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization", "role": "Required", "role_reason": "An item prepared to distinguish Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing research-product description states that MVA85A is a modified vaccinia Ankara vector expressing antigen 85A. This identity does not establish equivalence with existing BCG, other boosters or products, or provide vaccination/suitability guidance.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified. Review of existing content remains incomplete.", "missingness": "Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization." }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about allocation and assessment in the double-blind phase 2b design?", "needed": "Randomization/placebo, allocation concealment and tuberculosis case adjudication", "role": "Required", "role_reason": "An item prepared to distinguish Randomization/placebo, allocation concealment and tuberculosis case adjudication and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Randomization/placebo, allocation concealment and tuberculosis case adjudication must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Randomization/placebo, allocation concealment and tuberculosis case adjudication as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original study is a double-blind, placebo-controlled phase 2b RCT. The original B1 axis and double-blind label alone do not verify sequence generation, allocation concealment or blinding of all case assessments and follow-up.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified. Review of existing content remains incomplete.", "missingness": "Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Randomization/placebo, allocation concealment and tuberculosis case adjudication." }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do 2797 participants differ from tuberculosis denominators 1399/1395?", "needed": "Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions", "role": "Required", "role_reason": "An item prepared to distinguish Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial size of 2797 and tuberculosis results 32/1399 versus 39/1395 are preserved separately. Group denominators are not added or subtracted to calculate new missing/excluded counts or completion rates.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified. Review of existing content remains incomplete.", "missingness": "Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions." }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "How were incident tuberculosis cases defined and adjudicated?", "needed": "Incident TB, clinical/test/severity definitions and case collection criteria", "role": "Required", "role_reason": "An item prepared to distinguish Incident TB, clinical/test/severity definitions and case collection criteria and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Incident TB, clinical/test/severity definitions and case collection criteria must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Incident TB, clinical/test/severity definitions and case collection criteria as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original endpoint is tuberculosis incidence. Definitions of active/confirmed/clinical tuberculosis, microbiological criteria and severity/site-specific results are not filled in from definitions absent from this summary.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified. Review of existing content remains incomplete.", "missingness": "Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Incident TB, clinical/test/severity definitions and case collection criteria." }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are tuberculosis disease, infection and immune response the same outcome?", "needed": "Separate definitions/denominators for disease and infection/immune surrogate markers", "role": "Required", "role_reason": "An item prepared to distinguish Separate definitions/denominators for disease and infection/immune surrogate markers and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Separate definitions/denominators for disease and infection/immune surrogate markers must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Separate definitions/denominators for disease and infection/immune surrogate markers as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The quantitative result in the current stored summary is tuberculosis disease incidence. The summary is not presented as providing numerical results for infection incidence, test conversion or immune response/preventive effects.", "condition_status": "Unverified", "status_reason": "This is a record from the stored summary. The currently required information remains unverified. Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified. Review of existing content remains incomplete.", "missingness": "Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Separate definitions/denominators for disease and infection/immune surrogate markers." }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does up to 37 months mean the same observation period for everyone?", "needed": "Maximum follow-up, duration/censoring and first/recurrent event units", "role": "Required", "role_reason": "An item prepared to distinguish Maximum follow-up, duration/censoring and first/recurrent event units and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Maximum follow-up, duration/censoring and first/recurrent event units must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Maximum follow-up, duration/censoring and first/recurrent event units as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing research description states follow-up up to 37 months. This is not changed to 37-month completion by everyone, incidence over a fixed duration or lifelong prevention, and no new person-time or annualized rate is calculated.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified. Review of existing content remains incomplete.", "missingness": "Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Maximum follow-up, duration/censoring and first/recurrent event units." }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which groups do the tuberculosis fractions, proportions and absolute difference describe?", "needed": "MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p", "role": "Required", "role_reason": "An item prepared to distinguish MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserves original MVA85A 32/1399 (2.3%) versus control 39/1395 (2.8%), and absolute difference −.5%p. No new difference, incidence rate, NNT, absolute-difference CI or individual protection probability is calculated.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified. Review of existing content remains incomplete.", "missingness": "Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p." }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "What possibilities remain within the interval around vaccine efficacy 17.3%?", "needed": "Original 17.3%, 95% CI −31.9~48.2, model and comparison direction", "role": "Required", "role_reason": "An item prepared to distinguish Original 17.3%, 95% CI −31.9~48.2, model and comparison direction and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Original 17.3%, 95% CI −31.9~48.2, model and comparison direction as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original Korean account states that vaccine efficacy 17.3% (95% CI −31.9~48.2) leaves possibilities in both benefit and harm directions. The finding of no significant benefit is not changed to an exact effect of 0, equivalence, exclusion of all important benefits or safety.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified. Review of existing content remains incomplete.", "missingness": "Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction." }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are the finding of no significant benefit or candidate success and the wide interval preserved together?", "needed": "Original D34/E0, no significant benefit and precision of the original CI", "role": "Required", "role_reason": "An item prepared to distinguish Original D34/E0, no significant benefit and precision of the original CI and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Original D34/E0, no significant benefit and precision of the original CI must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Original D34/E0, no significant benefit and precision of the original CI as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing central summary/grade records no significant reduction in disease and D34. The interval −31.9~48.2 and wording allowing substantial benefit are also preserved, without a new significance, grade or overall vaccine-effect judgment.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified. Review of existing content remains incomplete.", "missingness": "Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Original D34/E0, no significant benefit and precision of the original CI." }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "What prespecified analysis/endpoint specification applies to tuberculosis disease?", "needed": "Original main disease time point, prespecified hierarchy, infection/safety and multiplicity", "role": "Required", "role_reason": "An item prepared to distinguish Original main disease time point, prespecified hierarchy, infection/safety and multiplicity and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Original main disease time point, prespecified hierarchy, infection/safety and multiplicity as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original is a large candidate vaccine trial of tuberculosis disease. Infection, immune responses, safety, other periods or subgroups are not promoted to the main efficacy outcome.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified. Review of existing content remains incomplete.", "missingness": "Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity." }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?", "needed": "Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses", "role": "Required", "role_reason": "An item prepared to distinguish Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original comparison is an added candidate strategy after BCG in both groups. Actual MVA/control adherence, crossover, other vaccines, prevention/treatment or exposure differences are not newly filled in.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified. Review of existing content remains incomplete.", "missingness": "Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses." }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?", "needed": "The same MVA85A020 trial, shared denominators/durations and added-effect question", "role": "Required", "role_reason": "An item prepared to distinguish The same MVA85A020 trial, shared denominators/durations and added-effect question and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for The same MVA85A020 trial, shared denominators/durations and added-effect question must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking The same MVA85A020 trial, shared denominators/durations and added-effect question as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Tameris2013MVA85A020 is one existing clinical report. The parent disease judgment, this sheet, safety outcomes, repeated time points or groups are not added as new independent trials or total participants.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Unique clinical trial, participant and independent replication totals have not been verified and are not recorded. Review of existing content remains incomplete.", "missingness": "Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for The same MVA85A020 trial, shared denominators/durations and added-effect question." }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the 1245 first BCG vaccination manuscript a direct trial of an added booster?", "needed": "Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants", "role": "Required", "role_reason": "An item prepared to distinguish Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Existing cross-citation 1245 refers to a first BCG vaccination manuscript in unvaccinated children, B64. That manuscript/trial has not been read in this preparation and is not created as a direct trial or same-population replication of the added MVA effect.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but That original manuscript/trial, conditions/denominators and direct linkage remain unverified. Review of existing content remains incomplete.", "missingness": "That original manuscript/trial, conditions/denominators and direct linkage remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants." }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?", "needed": "Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention", "role": "Required", "role_reason": "An item prepared to distinguish Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Existing cross-citation 2743 refers to shortened treatment of established pulmonary tuberculosis, C56. The original title/relative URL is preserved, without changing it to a preventive effect, an independent vaccine trial or treatment guidance.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but That manuscript/trial has not been read and is not a direct result for a preventive booster. Review of existing content remains incomplete.", "missingness": "That manuscript/trial has not been read and is not a direct result for a preventive booster.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention." }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the Aeras/Wellcome/OETC relationships and commercial rights?", "needed": "Nonprofit/development consortium, Oxford/Emergent relationships and actual roles", "role": "Required", "role_reason": "An item prepared to distinguish Nonprofit/development consortium, Oxford/Emergent relationships and actual roles and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Nonprofit/development consortium, Oxford/Emergent relationships and actual roles as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original funding names Aeras, Wellcome Trust and the Oxford-Emergent Tuberculosis Consortium. Oxford development and Emergent commercialization rights/consortium participation are preserved as the original history of mixed independence.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources. Review of existing content remains incomplete.", "missingness": "Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles." }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do development rights and mixed funding verify all COI and product support?", "needed": "Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority", "role": "Required", "role_reason": "An item prepared to distinguish Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original mixed funding and commercial development involvement are not expanded into new certification of product provision, all employee authors, all COI or absence of researcher independence. The original I1 axis is preserved as history.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified. Review of existing content remains incomplete.", "missingness": "Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority." }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were the registration number and prespecified disease/infection plans actually read?", "needed": "NCT00953927 record, plans/change history, missing data and hierarchy", "role": "Required", "role_reason": "An item prepared to distinguish NCT00953927 record, plans/change history, missing data and hierarchy and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for NCT00953927 record, plans/change history, missing data and hierarchy must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking NCT00953927 record, plans/change history, missing data and hierarchy as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserves original NCT00953927. The number/manuscript account alone does not establish actual reading of the registry, protocol or SAP, or fulfillment of prespecified disease/infection conditions.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read. Review of existing content remains incomplete.", "missingness": "Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for NCT00953927 record, plans/change history, missing data and hierarchy." }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What denominators and periods apply to local, systemic and serious adverse events?", "needed": "Distinct safety specifications for original 89/45%, 80/76% and 18/18%", "role": "Supplementary", "role_reason": "An item prepared to distinguish Distinct safety specifications for original 89/45%, 80/76% and 18/18% and connect the selected question's required materials with the available materials.", "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.", "criterion": "Relevant original materials and the scope of analysis for Distinct safety specifications for original 89/45%, 80/76% and 18/18% must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Distinct safety specifications for original 89/45%, 80/76% and 18/18% as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserves local events 89% versus 45%, systemic events 80% versus 76% and serious events 18% versus 18%. Differences, risk ratios, event counts or disease denominators are not newly calculated, and these results are not combined into one safety rate.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified. Review of existing content remains incomplete.", "missingness": "Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Distinct safety specifications for original 89/45%, 80/76% and 18/18%." }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Does absence of related serious events mean zero risk or a vaccination recommendation?", "needed": "Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms", "role": "Supplementary", "role_reason": "An item prepared to distinguish Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms and connect the selected question's required materials with the available materials.", "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.", "criterion": "Relevant original materials and the scope of analysis for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original states that there were no related serious adverse events, while all serious events 18%/18% are separate. Wording about absence of related events is not changed to zero risk, safety of all vaccines/long-term use or a vaccination/suitability recommendation.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified. Review of existing content remains incomplete.", "missingness": "Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms." }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can the result be generalized to BCG policy, other candidates/populations, prevention or treatment?", "needed": "Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases", "role": "Required", "role_reason": "An item prepared to distinguish Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This sheet contains historical original material on the added effect of that candidate. Original wording about Korean national BCG immunization is preserved in the full stored summary, without newly confirming current policy or creating guidance on vaccine selection, use, suitability, treatment or prevention.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified. Review of existing content remains incomplete.", "missingness": "New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases." }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was actually read of the stored summary, external papers/manuscripts and links?", "needed": "Full stored summary, PMID23391465/two reference URLs and unread external sources", "role": "Required", "role_reason": "An item prepared to distinguish Full stored summary, PMID23391465/two reference URLs and unread external sources and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Full stored summary, PMID23391465/two reference URLs and unread external sources must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Full stored summary, PMID23391465/two reference URLs and unread external sources as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The full stored summary was read for preparation and labeled 'Summary read'. Original clinical-report and relative BCG/shortened-treatment URLs are preserved; external full papers/manuscripts, registration/plans and COI are labeled 'Not read'. Existing cross-citation checks are not inherited as current content review.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but External access, abstracts/full texts, link/click testing and comparison with original papers were not performed. Review of existing content remains incomplete.", "missingness": "External access, abstracts/full texts, link/click testing and comparison with original papers were not performed.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Full stored summary, PMID23391465/two reference URLs and unread external sources." }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?", "needed": "Subclaim D, parent D34, 2026-08-26, false/empty values and correction history", "role": "Required", "role_reason": "An item prepared to distinguish Subclaim D, parent D34, 2026-08-26, false/empty values and correction history and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Subclaim D, parent D34, 2026-08-26, false/empty values and correction history as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserves the full stored summary's Korean/English manuscripts, parent D34/Caution, original axes/false values, empty correction and deliberation records, and 2026-08-26. Absent subclaim D score, status or axes are not filled with parent values.", "condition_status": "Partly verified", "status_reason": "This is a record from the stored summary. Some information exists in the stored summary, but The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then. Review of existing content remains incomplete.", "missingness": "The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history." }, { "item_id": "N26", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are condition preservation/application, case preparation and content review distinguished?", "needed": "Records of condition preservation, freezing/application, case preparation and incomplete content review", "role": "Required", "role_reason": "An item prepared to distinguish Records of condition preservation, freezing/application, case preparation and incomplete content review and connect the selected question's required materials with the available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and the scope of analysis for Records of condition preservation, freezing/application, case preparation and incomplete content review must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "A proposal for follow-up materials linking Records of condition preservation, freezing/application, case preparation and incomplete content review as a separate item; no new research, calculation or testing is performed in this preparation.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Condition preservation, freezing, application, case production and content review are separate records. Review of the existing content is incomplete; record counts are not totals of unique clinical trials/participants.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Review of the existing content is incomplete and clinical source material was not newly verified. Review of the existing content remains incomplete.", "missingness": "Review of the existing content is incomplete and clinical source material was not newly verified.", "uncertainty": "This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables or planning materials, or user-provided copies, for Records of condition preservation, freezing/application, case preparation and incomplete content review." } ], "reports": [ { "report_id": "S01", "title": "Tameris et al. 2013 MVA85A 020", "url": "https://pubmed.ncbi.nlm.nih.gov/23391465/", "report_type": "Double-blind, placebo-controlled phase 2b RCT", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2929-MVA85A-020", "independent_replication": null, "observed_result": "32/1399 versus 39/1395; efficacy 17.3% (95% CI -31.9~48.2), absolute difference -0.5%p. Preserves the disease proportions and wide efficacy interval in the existing reader answer, and the original D34/subclaim D. Denominators are not added or subtracted, and new rates, effects, CIs or individual predictions are not calculated. Infection/immune-response values, exact follow-up and endpoint definitions remain unverified.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23391465/" } ] }, { "report_id": "S02", "title": "1245 First BCG vaccination × Active tuberculosis in unvaccinated children (B 64)", "url": "https://chamgap.com/verdicts/immunity/bcg-first-vaccination-unvaccinated-children-active-tuberculosis/", "report_type": "Citation-only report; no row in the original review summary's evidence list", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "REF2929-VERDICT1245", "independent_replication": null, "observed_result": "BCG itself and an added booster are different questions. Existing cross-citation checks and bibliographic records are preserved as history; clinical content, judgments or numbers are not transferred as direct values for the selected question.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External manuscript", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Official source", "url": "https://chamgap.com/verdicts/immunity/bcg-first-vaccination-unvaccinated-children-active-tuberculosis/" } ] }, { "report_id": "S03", "title": "2743 Four months of rifapentine and moxifloxacin × Shortened treatment of drug-susceptible pulmonary tuberculosis (C 56)", "url": "https://chamgap.com/verdicts/general/four-month-rifapentine-moxifloxacin-drug-susceptible-pulmonary-tuberculosis/", "report_type": "Citation-only report; no row in the original review summary's evidence list", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "REF2929-VERDICT2743", "independent_replication": null, "observed_result": "Prevention and shortened treatment are different questions. Existing cross-citation checks and bibliographic records are preserved as history; clinical content, judgments or numbers are not transferred as direct values for the selected question.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External manuscript", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Official source", "url": "https://chamgap.com/verdicts/general/four-month-rifapentine-moxifloxacin-drug-susceptible-pulmonary-tuberculosis/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Tameris2013MVA85A020/PMID23391465 is a double-blind, placebo-controlled phase 2b candidate trial in 2797 healthy infants already vaccinated with BCG. Tuberculosis denominators 1399/1395, follow-up up to 37 months, and infection, immune-response and safety endpoints are kept separate. The historical finding of no significant benefit and the wide efficacy interval are both preserved. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S02 is a manuscript reference in the existing cross-citations to 1245, first BCG vaccination and active tuberculosis in unvaccinated children, B64. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S03 is a manuscript reference in the existing cross-citations to 2743, shortened treatment of established drug-susceptible pulmonary tuberculosis, C56. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-10" }