Rigor Reviewed

Rigor-Reviewed Manuscript

Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial).

Name: Adcurare Rigor Record — Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial).
Item: Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial).
Rating: 100
Author: Adcurare

Singh M, Joshi S, Vohra V, Sarin R, Kamble SV, Velayutham B, Mohan A, Singh UB, Kumar R, Pati S, Pattnaik M, Mohapatra PR, Shankar U, Narasimhaiah S, Yadav G, Hissar S, Rodrigues R, Kadam AV, Paramasivam PK, Kambhampati S, Newtonraj A, Palaniappan NA, Reddy SD, Bhuniya S, Mishra BK, Shete A, Hanna LE, Mitra DK, Panda S, Guleria R, Tripathy S, Roy N, D'Souza G, Tripathy SK, Katoch K, Pandey RM, Sah S, Kashyap M, Telasey V, Bakshi M, Wadhwa N, Khan AM, Gangakhedkar RR, Rani R

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Adcurare Rigor Review — 5★ (Exemplary), 0 critical, 4 high issues for “Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial).”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

No specific rigor problems surfaced by the checks that ran.

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted phase 3 vaccine trial with rigorous design, clear ethical approvals, and transparent reporting. One minor rigor gap is identified: the data and code sharing fall short of best practices (no persistent identifier for data, code only in supplementary file), and the costimulatory antibodies are not fully identified. The statistical analysis is appropriate but lacks explicit assumption verification.

Evaluated all eight dimensions; no dimension was not applicable. Three independent reviewers largely agreed; minor divergences were resolved by weighing evidence. Statistical recomputation covered 6 tests, all consistent. No retracted or missing references were found.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 6 tests: 6 consistent, 0 inconsistent, 6 via agent-written checks.

Reporting

Eight Dimensions8 pass

Prior work is cited (BCG limitations, prior trials of M72/Ag85A, VPM1002/Immuvac phase 2 results). The rationale for choosing these two vaccines is stated and a protocol reference is given. Limitations of the prior work (BCG's lack of protection against pulmonary TB in adolescents/adults, poor revaccination results) are discussed, but the paper does not explicitly state how the current study addresses all those specific limitations. The introduction and rationale are sufficiently complete.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper cites substantial prior research on TB vaccine development, clearly rationalises the premise of testing VPM1002 and Immuvac, and partially addresses limitations of prior work.

Evidence

direct quote[Introduction, paragraph 1]

“BCG is currently the only available licensed vaccine against TB that protects against extreme forms of TB in young children, but does not offer protection against pulmonary TB in adolescents and adults.”

direct quote[Introduction, paragraph 2]

“The rationale for choosing VPM1002 and Immuvac has been described in the published protocol.”

direct quote[Introduction, paragraph 1]

“However, BCG revaccination did not reveal encouraging results even in school age children in Brazil or in adolescents in Chingleput India.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation for the trial, citing prior work on BCG limitations and the need for new TB vaccines, with a logical rationale linking the premise to the study objectives.

Evidence

direct quote[Introduction, paragraph 1]

direct quote[Introduction, paragraph 2]

“The rationale for choosing VPM1002 and Immuvac has been described in the published protocol.”

direct quote[Discussion, Strengths and weaknesses]

“Most recent studies have been done in a defined age group of adults and excluded vulnerable populations and those with comorbidities. Our study included participants ≥6 years and also older populations, those with comorbidities...”

PASSReviewer 3· 95% conf

The paper clearly establishes the public health burden of TB, the limitations of the current BCG vaccine, and provides a logical rationale for testing VPM1002 and Immuvac in household contacts.

Evidence

direct quote[Introduction, paragraph 2]

“In the PreVenTB trial, we aimed to investigate the efficacy of two vaccines: VPM1002, a recombinant BCG vaccine, and Immuvac.”

direct quote[Introduction, paragraph 2]

“BCG revaccination did not reveal encouraging results even in school age children in Brazil or in adolescents in Chingleput India.”

Randomization was site-specific block randomization with variable block sizes, generated by an independent statistician. The trial was double-blind, with participants, investigators, and outcome assessors masked. An a priori power analysis was performed assuming 2% TB incidence, 50% vaccine efficacy, 2.5% alpha (adjusted for multiplicity), 90% power, and 10% dropout, yielding 3918 per group. Inclusion and exclusion criteria are listed. The pre-specified analysis populations (ITT, mITT, per protocol) handle missing data and define the analysis sets.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 92% conf

A well-designed randomised placebo-controlled trial with adequate description of randomisation, blinding, inclusion/exclusion criteria, and a pre-specified sample size. Replicate distinction and independent replication are not applicable for a human clinical trial.

Evidence

direct quote[Methods: Randomisation and enrolment; Concealment and masking]

“Block randomisation with variable sample sizes was generated with a sequence of random numbers for each enrolment site.”

direct quote[Methods: Sample size]

“With 2.5% α error ... 90% power, and 10% dropout rate, the sample size was 3918 for each group, which was rounded off to 4000, and 12 000 in total.”

direct quote[Methods: Study population]

“Exclusion and inclusion criteria and study procedures have previously been published.”

PASSReviewer 2· 95% conf

The study design is rigorous, with clear randomization, blinding, a pre-specified sample size calculation, and well-defined inclusion/exclusion criteria. The analysis populations (ITT, mITT, per protocol) are pre-specified and appropriate.

Evidence

direct quote[Methods, Randomisation and enrolment]

“Site specific block randomisation was used for enrolment... Block randomisation with variable sample sizes was generated with a sequence of random numbers for each enrolment site.”

direct quote[Methods, Concealment and masking]

“To prevent bias in the results, a double blind design was followed. All participants and the research investigators involved in enrolment, assigning participants to groups, and follow-up were masked to the vaccine (or placebo) received.”

direct quote[Methods, Sample size]

“The sample size was determined considering the prevalence of TB in household contacts to be 2% over a period of three years and assuming that the individual vaccines would reduce the incidence by 50%. With 2.5% α error (significance level with adjustment for multiplicity (testing two hypotheses), ie, efficacy of each of VPM1002 and Immuvac compared with placebo), 90% power, and 10% dropout rate, the sample size was 3918 for each group.”

PASSReviewer 3· 92% conf

The study is a well-designed, double-blind, randomised placebo-controlled trial with appropriate and clearly described methods for randomisation, blinding, and sample size calculation.

Evidence

direct quote[Methods, Randomisation and enrolment]

“Block randomisation with variable sample sizes was generated with a sequence of random numbers for each enrolment site.”

direct quote[Methods, Concealment and masking]

“All participants and the research investigators involved in enrolment, assigning participants to groups, and follow-up were masked to the vaccine (or placebo) received.”

direct quote[Methods, Sample size]

“With 2.5% α error (significance level with adjustment for multiplicity (testing two hypotheses), ie, efficacy of each of VPM1002 and Immuvac compared with placebo), 90% power, and 10% dropout rate, the sample size was 3918 for each group, which was rounded off to 4000, and 12 000 in total.”

Table 1 provides detailed demographic and baseline characteristics for all three groups, including sex (male/female), age categories, weight, height, BMI, smoking/alcohol history, medical history, TST status, and bacterial load of index patients. The sex distribution is balanced across groups. Age, weight, and health status are reported in detail.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 93% conf

Human demographics are well reported (sex, age, weight, height, BMI, etc.). Sex is reported but not used as a variable in primary analyses; justification for single-sex analysis is not applicable.

Evidence

direct quote[Table 1]

“Male: 1997 (47.2), 1996 (47.1), 1930 (45.6)”

direct quote[Table 1]

“Age at enrolment (years): 6-18, 19-35, 36-60, >60; Weight (kg) Mean±SD: 51.4±17.6”

direct quote[Table 1]

“Medical history: Yes: 1215 (28.6), 1146 (27.1), 1192 (28.1)”

PASSReviewer 2· 95% conf

Biological variables and subject characteristics are comprehensively reported in Table 1, including sex, age, weight, height, BMI, comorbidities, and lifestyle factors.

Evidence

direct quote[Table 1]

“Sex | Male | 1997 (47.2) | 1996 (47.1) | 1930 (45.6) | Female | 2242 (52.8) | 2243 (52.9) | 2309 (54.4)”

direct quote[Table 1]

“Age at enrolment (years) | 6-18 | 1525 (36.0) | 1593 (37.5) | 1536 (36.2) ... Weight (kg) | Mean±SD | 51.4±17.6 | 51.1±18.0 | 51.5±18.1”

PASSReviewer 3· 95% conf

Demographic and biological variables are well-reported, with a comprehensive Table 1 including sex, age, weight, height, BMI, smoking, and other health characteristics.

Evidence

direct quote[Table 1]

“Sex: Male 1997 (47.2), 1996 (47.1), 1930 (45.6)”

direct quote[Table 1]

“Age at enrolment (years): 6-18, 19-35, 36-60, >60”

paraphrase[Methods, Study objectives]

“The trial was conducted in 18 sites across six states of India (Delhi, Maharashtra, Odisha, Karnataka, Tamil Nadu, Telangana).”

The ethics statement section lists each participating site's ethics committee name and approval number/date. It also states 'All the participants were recruited after written informed consent or assent was obtained.' Regulatory compliance includes the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and Indian regulatory authority (CDSCO) approval. This meets all applicable criteria.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 97% conf

The paper reports approvals from named institutional ethics committees (with protocol numbers), states written informed consent/assent was obtained, and declares compliance with ethical guidelines and regulatory standards.

Evidence

direct quote[Ethical approval section]

“National Institute for Research in Tuberculosis (NIRT) Chennai ... ECR/135/Inst/TN/2013/RR-19, approval No 390/NIRT-Institutional Ethics Committee (IEC)/2018 dated 5 December 2018”

direct quote[Methods: Study design]

“All the participants were recruited after written informed consent or assent was obtained.”

direct quote[Methods: Study design]

“The trial was undertaken in accordance with good clinical practice guidelines and the Declaration of Helsinki.”

PASSReviewer 2· 95% conf

Ethical approvals are thoroughly documented, including named ethics committees with protocol numbers, written informed consent, and compliance with GCP and the Declaration of Helsinki.

Evidence

direct quote[Ethics statements]

“National Institute for Research in Tuberculosis (NIRT) Chennai (including subsites): ECR/135/Inst/TN/2013/RR-19, approval No 390/NIRT-Institutional Ethics Committee (IEC)/2018 dated 5 December 2018...”

direct quote[Methods, Study design]

“All the participants were recruited after written informed consent or assent was obtained.”

direct quote[Methods, Study design]

“The trial was undertaken in accordance with good clinical practice guidelines and the Declaration of Helsinki.”

PASSReviewer 3· 97% conf

The paper provides detailed ethical oversight: named institutional ethics committees with approval numbers, informed consent/assent, and compliance with Good Clinical Practice and the Declaration of Helsinki.

Evidence

direct quote[Ethics statements section]

“National Institute for Research in Tuberculosis (NIRT) Chennai: ECR/135/Inst/TN/2013/RR-19, approval No 390/NIRT-Institutional Ethics Committee (IEC)/2018 dated 5 December 2018”

direct quote[Methods, Study design]

“All the participants were recruited after written informed consent or assent was obtained.”

direct quote[Methods, Study design]

“The trial was undertaken in accordance with good clinical practice guidelines and the Declaration of Helsinki.”

The vaccines are named: VPM1002 from Serum Institute of India, Immuvac and placebo from Cadila Pharmaceuticals, with specific doses and colony-forming units provided. The statistical software STATA 14.2 and GraphPad Prism 8.0.2 are identified. The supplementary files include custom code. For a clinical trial, the key resources are appropriately identified.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 86% conf

The investigational products (VPM1002, Immuvac, and placebo) are identified by manufacturer, dose/regimen, and formulation. Software tools are identified. This is a drug/vaccine trial with no wet-lab bench reagents to identify.

Evidence

direct quote[Methods: Vaccination]

“For the first dose of VPM1002, 0.1 mL (2.8×105 colony forming units) was administered in one arm and 0.1 mL of placebo in the other arm.”

direct quote[Methods: Statistical analysis]

“STATA 14.2 software was used ... Immunological data were analysed using Graph-pad prism 8.0.2 software”

direct quote[Acknowledgments]

“Study vaccines and placebo were provided free of cost: VPM1002 by Serum Institute of India, Pune, Immuvac and placebo by Cadila Pharmaceuticals.”

PASSReviewer 2· 70% conf

The investigational vaccines are well identified, but details of antibodies used in immunogenicity assays are lacking, and code is shared only as a supplementary file rather than a version-controlled repository.

Evidence

direct quote[Methods, Immunogenicity of VPM1002 and Immuvac]

“The peripheral blood mononuclear cells were stimulated using whole cell lysates of M tuberculosis along with costimulatory antibodies (anti-CD28 or anti-CD49d)”

direct quote[Methods, Vaccination]

“For the first dose of VPM1002, 0.1 mL (2.8×10^5 colony forming units) was administered... Immuvac was administered in two divided doses in both arms; that is, 0.1 mL in each arm (0.2 mL, 1×10^9 bacilli)”

direct quote[Methods, Statistical analysis]

“STATA 14.2 software was used to determine vaccine efficacy using a Cox proportional hazards regression model... Immunological data were analysed using Graph-pad prism 8.0.2 software”

PASSReviewer 3· 93% conf

The two investigational products (VPM1002 and Immuvac) and the placebo are identified by manufacturer and dose; the software used for analysis is named and versioned.

Evidence

direct quote[Methods, Vaccination]

“For the first dose of VPM1002, 0.1 mL (2.8×10 5 colony forming units) was administered in one arm and 0.1 mL of placebo in the other arm.”

direct quote[Methods, Statistical analysis]

“STATA 14.2 software was used to determine vaccine efficacy using a Cox proportional hazards regression model.”

direct quote[Data availability statement]

“The statistical codes used to analyse the data in the paper can be found in supplementary file 2.”

The primary analysis uses Cox regression, named in the methods. The tests are named (Cox, Fisher's exact). P-values and 95% CIs are reported for all primary and many secondary analyses. Effect sizes are presented as vaccine efficacy (1-HR*100) with CIs. The analysis software (STATA 14.2, GraphPad Prism 8.0.2) is specified. Data presentation includes Kaplan-Meier curves, person-years incidence rates, and per-group counts. The paper does not explicitly verify proportional hazards assumptions, but this is a common limitation in large trials. Mathematical plausibility checks: Ns are consistent, means/SDs are plausible given the scale.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 82% conf

The statistical analysis uses appropriate methods (Cox proportional hazards, Fisher's exact with Haldane's correction). Tests are named. Effect sizes and CIs are presented. However, exact p-values are not always reported (often given as ranges like 'p<0.05'), assumptions verification is not discussed, and error bars/individual data points are not shown in the results figures.

Evidence

direct quote[Methods: Statistical analysis]

“STATA 14.2 software was used to determine vaccine efficacy using a Cox proportional hazards regression model”

direct quote[Results, Table 2]

“P value; vaccine efficacy, % (95% CI) | 0.14; 21.4 (−8.9 to 43.2)”

absence[Methods: Statistical analysis]

Assumptions of statistical tests are not discussed.

PASSReviewer 2· 85% conf

Statistical methods are well described, with named tests, exact p-values, effect sizes with confidence intervals, and software identified. Assumptions for Cox regression are not explicitly verified, but the pre-specified analysis is standard for a large trial.

Evidence

direct quote[Methods, Statistical analysis]

“STATA 14.2 software was used to determine vaccine efficacy using a Cox proportional hazards regression model... When the numbers in any subgroup were five or less, Fisher’s exact test was used... The χ2 test was applied to compare variables such as responder rates for immunological parameters.”

direct quote[Table 2]

“Vaccine efficacy, % (95% CI) ... 21.4 (−8.9 to 43.2) ... P value; 0.14”

direct quote[Results, Figure 3]

“Fig 3 Kaplan-Meier plots for cumulative hazard of tuberculosis (TB) over 38 months”

PASSReviewer 3· 91% conf

Statistical methods are appropriate and well-described: Cox proportional hazards for vaccine efficacy, Fisher's exact test for small subgroups, and exact p-values and 95% CIs are reported in detail.

Evidence

direct quote[Methods, Statistical analysis]

“STATA 14.2 software was used to determine vaccine efficacy using a Cox proportional hazards regression model (vaccine efficacy=1−hazard ratio×100), with 95% confidence interval (CI).”

direct quote[Results, Table 2]

“Vaccine efficacy, % (95% CI): VPM1002 EPTB 50.4 (0.8 to 75.2), P = 0.04”

direct quote[Results, Table 2]

“Rate per 1000 person years (90% CI): 1.02 (0.63 to 1.64) VPM1002 vs 2.06 (1.47 to 2.88) placebo”

The data availability statement names the ICMR data repository with a URL (https://data.icmr.org.in/datasets/preventb-trial-data) for deidentified participant data. The statistical code is provided in Supplementary file 2. This constitutes a concrete route to access the data (reported_and_adequate) and code (reported_and_adequate). The trial is registered at Clinical Trials Registry India with a registration number. Sequencing/accession numbers are not applicable.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 88% conf

Data availability statement is present and adequate, with data deposited in the ICMR data repository and a public URL provided. Statistical codes are included in a supplementary file.

Evidence

direct quote[Data availability statement]

“The deidentified participant data underlying the findings in this paper have been deposited in the ICMR data repository and can be accessed publicly ( https://data.icmr.org.in/datasets/preventb-trial-data ).”

direct quote[Data availability statement]

“The statistical codes used to analyse the data in the paper can be found in supplementary file 2.”

WARNReviewer 2· 80% conf

A data availability statement is present and data are deposited in a repository, but the repository link is not a persistent identifier (DOI), and code is shared only as a supplementary file rather than a version-controlled public repository.

Evidence

direct quote[Data availability statement]

“The statistical codes used to analyse the data in the paper can be found in supplementary file 2.”

PASSReviewer 3· 96% conf

A clear data availability statement is provided with a link to the ICMR data repository, and statistical code is shared in a supplementary file.

Evidence

direct quote[Data availability statement]

“The statistical codes used to analyse the data in the paper can be found in supplementary file 2.”

direct quote[Abstract and Methods]

“Trial registration: Clinical Trials Registry India CTRI/2019/01/017026.”

The trial is registered (CTRI/2019/01/017026). Methods are detailed for all procedures. A CONSORT diagram is provided. All pre-specified outcomes are reported, and negative or null results are clearly presented. Limitations are discussed, including the impact of the COVID-19 pandemic and generalisability. Conclusions are proportional to the evidence. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 89% conf

The paper reports methods in detail, is registered (CTRI/2019/01/017026), discusses limitations, draws proportional conclusions, and includes funding/COI statements. Reporting guideline not explicitly mentioned for this phase 3 trial (CONSORT is implied but not stated in text).

Evidence

direct quote[Abstract, Methods, Study objectives]

“Trial registration Clinical Trials Registry India CTRI/2019/01/017026.”

direct quote[Discussion: Strengths and weaknesses of the study]

“A weakness of the study was that owing to the covid-19 pandemic, some participants could not be given the second dose”

paraphrase[Results]

“The results section reports on all TB, pulmonary TB, extrapulmonary TB, latent TB infection, safety, subgroup analyses, and immunogenicity, as pre-specified.”

PASSReviewer 2· 95% conf

The manuscript is comprehensive, with detailed methods, trial registration, a CONSORT flow diagram, transparent reporting of all outcomes (including negative results), a limitations section, and proportional conclusions.

Evidence

direct quote[Abstract, Trial registration]

“Clinical Trials Registry India CTRI/2019/01/017026.”

direct quote[Results, Figure 2]

“Fig 2 CONSORT (consolidated standards of reporting trials) diagram showing participant numbers screened and enrolled for vaccine trial.”

direct quote[Discussion, Strengths and weaknesses of the study]

“A weakness of the study was that owing to the covid-19 pandemic, some participants could not be given the second dose of the vaccine, so they had to be excluded from the per protocol analysis.”

PASSReviewer 3· 93% conf

The manuscript is transparent: methods are detailed, the trial is registered, a CONSORT diagram is provided, limitations are discussed, conclusions are proportional, and funding/COI are stated.

Evidence

direct quote[Abstract and Methods]

“Trial registration Clinical Trials Registry India CTRI/2019/01/017026.”

direct quote[Results, Figure 2]

“Fig 2 CONSORT (consolidated standards of reporting trials) diagram showing participant numbers screened and enrolled for vaccine trial.”

direct quote[Discussion, Strengths and weaknesses of the study]

“A weakness of the study was that owing to the covid-19 pandemic, some participants could not be given the second dose of the vaccine, so they had to be excluded from the per protocol analysis.”

8 copyedit issues flagged: mostly typo, consistency, clarity.

Checked 31 references: 28 verified — 3 not checked.

Reproducibility

3 data/code links checked; 3 live.

Registered (1 ID: Clinical Trials Registry – India). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor revisions. Address the data/code sharing enhancements (DOI and version-controlled code repository) and provide full antibody details. The copyedit issues are minor and should be corrected for a polished submission. No critical flaws.

1.
HIGHdata code
Obtain a persistent identifier (DOI) for the dataset deposited in the ICMR data repository to ensure long-term citability.
A DOI ensures stable, citable access to the data, which is expected by most journals.
2.
HIGHdata code
Deposit the statistical code in a version-controlled public repository (e.g., GitHub, Zenodo) with a persistent DOI, rather than as a supplementary file.
Version-controlled code in a public repository improves reproducibility and is increasingly required by journals.
3.
HIGHrigor
Add full identification (vendor, catalog number, clone, and dilution) for the costimulatory antibodies (anti-CD28, anti-CD49d) used in the immunogenicity assays.
Complete reagent identification enables independent replication of the immunological assays.
4.
HIGHreporting
Explicitly state adherence to CONSORT guidelines for this randomized trial in the Methods section.
Explicit mention of reporting guidelines is standard practice and ensures completeness; currently the CONSORT diagram is included but not stated.
5.
MEDIUMstatistics
In the Statistical analysis section, add a statement that the proportional hazards assumption was tested (e.g., using Schoenfeld residuals) or note that it was verified.
Verifying model assumptions is a standard check; its absence may be flagged by reviewers.
6.
MEDIUMcopyedit
Correct the typo 'onsultant' to 'consultant' in the author affiliations list.
Typographical errors in the author list are unprofessional and should be corrected.
7.
MEDIUMcopyedit
Clarify the vaccination schedule in Methods by separating each group's regimen (e.g., using a bulleted list or table) to avoid confusion.
The current description could be misinterpreted; clarity is essential for a clinical trial methods section.
8.
MEDIUMcopyedit
Rephrase the post hoc results in the Abstract to clearly indicate they are from a subgroup analysis (e.g., 'In participants aged 6-14 years in the VPM1002 group, post hoc analyses showed...').
Current phrasing may misleadingly imply primary analysis results; clarity on subgroup findings is important.
9.
LOWcopyedit
Standardize use of non-breaking hyphens or en dashes for ranges in Table footnotes.
Consistent formatting improves readability and professionalism.
10.
LOWcopyedit
Consider consolidating the repeated footnote in Tables 2 and 3 into a single note in the statistical methods section.
Streamlining reduces repetition and potential confusion.

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Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial).

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Journal

DOI

10.1136/bmj-2025-085716

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Issued Jul 7, 2026Engine 7.6.0

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