# MVA85A booster × Added tuberculosis prevention after BCG — Evidence checklist

Verdict 2929 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-10

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Healthy infants already vaccinated with BCG; distinguish the original 2797 participants from the tuberculosis denominators 1399/1395
- Ingredient, formulation and route: Addition of the original MVA85A candidate booster after BCG in both groups; no instruction on vaccine selection or use
- Dose: Not recorded
- Comparator: MVA85A versus placebo after BCG; separate from first BCG vaccination, an unvaccinated control or treatment of established disease
- Measured outcome: 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
- Questions outside this scope: 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

## Checklist items

### N01 · What are the subclaim and parent values for added protection after BCG?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: No new vaccine grade or score is created, and parent values are not inherited.
- Required materials and conditions: Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N02 · Were participants studied before BCG vaccination or as already vaccinated infants?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified.
- Required materials and conditions: Healthy, already vaccinated infants and the actual selection, age and setting boundaries
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Healthy, already vaccinated infants and the actual selection, age and setting boundaries.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design
- Related sources: S01

### N03 · Are added MVA85A and the effect of BCG itself the same question?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified.
- Required materials and conditions: BCG in both groups, the added candidate effect and comparison with placebo
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for BCG in both groups, the added candidate effect and comparison with placebo.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N04 · What research condition defines MVA85A?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified.
- Required materials and conditions: Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design
- Related sources: S01

### N05 · What is known about allocation and assessment in the double-blind phase 2b design?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified.
- Required materials and conditions: Randomization/placebo, allocation concealment and tuberculosis case adjudication
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Randomization/placebo, allocation concealment and tuberculosis case adjudication.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: S01

### N06 · How do 2797 participants differ from tuberculosis denominators 1399/1395?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified.
- Required materials and conditions: Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N07 · How were incident tuberculosis cases defined and adjudicated?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified.
- Required materials and conditions: Incident TB, clinical/test/severity definitions and case collection criteria
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Incident TB, clinical/test/severity definitions and case collection criteria.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N08 · Are tuberculosis disease, infection and immune response the same outcome?

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified.
- Required materials and conditions: Separate definitions/denominators for disease and infection/immune surrogate markers
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separate definitions/denominators for disease and infection/immune surrogate markers.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N09 · Does up to 37 months mean the same observation period for everyone?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified.
- Required materials and conditions: Maximum follow-up, duration/censoring and first/recurrent event units
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Maximum follow-up, duration/censoring and first/recurrent event units.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N10 · Which groups do the tuberculosis fractions, proportions and absolute difference describe?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified.
- Required materials and conditions: MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N11 · What possibilities remain within the interval around vaccine efficacy 17.3%?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified.
- Required materials and conditions: Original 17.3%, 95% CI −31.9~48.2, model and comparison direction
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application
- Related sources: S01

### N12 · How are the finding of no significant benefit or candidate success and the wide interval preserved together?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified.
- Required materials and conditions: Original D34/E0, no significant benefit and precision of the original CI
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original D34/E0, no significant benefit and precision of the original CI.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N13 · What prespecified analysis/endpoint specification applies to tuberculosis disease?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified.
- Required materials and conditions: Original main disease time point, prespecified hierarchy, infection/safety and multiplicity
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application
- Related sources: S01

### N14 · How do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified.
- Required materials and conditions: Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N15 · Are one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.
- Required materials and conditions: The same MVA85A020 trial, shared denominators/durations and added-effect question
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for The same MVA85A020 trial, shared denominators/durations and added-effect question.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N16 · Is the 1245 first BCG vaccination manuscript a direct trial of an added booster?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: That original manuscript/trial, conditions/denominators and direct linkage remain unverified.
- Required materials and conditions: Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S02

### N17 · Is the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: That manuscript/trial has not been read and is not a direct result for a preventive booster.
- Required materials and conditions: Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S03

### N18 · What are the Aeras/Wellcome/OETC relationships and commercial rights?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources.
- Required materials and conditions: Nonprofit/development consortium, Oxford/Emergent relationships and actual roles
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N19 · Do development rights and mixed funding verify all COI and product support?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified.
- Required materials and conditions: Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N20 · Were the registration number and prespecified disease/infection plans actually read?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read.
- Required materials and conditions: NCT00953927 record, plans/change history, missing data and hierarchy
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for NCT00953927 record, plans/change history, missing data and hierarchy.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N21 · What denominators and periods apply to local, systemic and serious adverse events?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified.
- Required materials and conditions: Distinct safety specifications for original 89/45%, 80/76% and 18/18%
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Distinct safety specifications for original 89/45%, 80/76% and 18/18%.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01

### N22 · Does absence of related serious events mean zero risk or a vaccination recommendation?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified.
- Required materials and conditions: Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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.
- Related sources: S01

### N23 · Can the result be generalized to BCG policy, other candidates/populations, prevention or treatment?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified.
- Required materials and conditions: Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01, S02, S03

### N24 · What was actually read of the stored summary, external papers/manuscripts and links?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: External access, abstracts/full texts, link/click testing and comparison with original papers were not performed.
- Required materials and conditions: Full stored summary, PMID23391465/two reference URLs and unread external sources
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Full stored summary, PMID23391465/two reference URLs and unread external sources.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01, S02, S03

### N25 · How are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then.
- Required materials and conditions: Subclaim D, parent D34, 2026-08-26, false/empty values and correction history
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01, S02, S03

### N26 · How are condition preservation/application, case preparation and content review distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Review of the existing content is incomplete and clinical source material was not newly verified.
- Required materials and conditions: Records of condition preservation, freezing/application, case preparation and incomplete content review
- Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Records of condition preservation, freezing/application, case preparation and incomplete content review.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
- Referenced methods: 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
- Related sources: S01, S02, S03

## Evidence and sources

### S01

Tameris et al. 2013 MVA85A 020

[PubMed](https://pubmed.ncbi.nlm.nih.gov/23391465/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 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.  
Record level: Outcome wording in the stored summary  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S02

1245 First BCG vaccination × Active tuberculosis in unvaccinated children (B 64)

[Official source](https://chamgap.com/verdicts/immunity/bcg-first-vaccination-unvaccinated-children-active-tuberculosis/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 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.  
Record level: Outcome wording in the stored summary  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review. |
| External manuscript | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S03

2743 Four months of rifapentine and moxifloxacin × Shortened treatment of drug-susceptible pulmonary tuberculosis (C 56)

[Official source](https://chamgap.com/verdicts/general/four-month-rifapentine-moxifloxacin-drug-susceptible-pulmonary-tuberculosis/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 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.  
Record level: Outcome wording in the stored summary  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review. |
| External manuscript | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- 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.

## Change history

2026-10-10 · Public page/materials 1.0. The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.