Kaimen Rigor reviewed

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Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

Name: Kaimen Rigor review — Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.
Item: Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.
Rating: 100
Author: Alpha1

Nyombayire J, Ingabire R, Mazzei A, Sharkey T, Umuhoza C, Mukamuyango J, Allen S, Tichacek A, Parker R, Wall KM, Katwere M, Keshinro B, Gaddah A, Wang Y, Forcheh CA, McLean C, Oriol-Mathieu V, Luhn K, Robinson C, Karita E

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

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DOI

10.1038/s41591-025-03932-z

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

Paper source

Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

No reported statistical tests were found to recompute.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen 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.

The paper is a well-conducted and transparently reported phase 3 randomized trial of an Ebola vaccine regimen in pregnant women. All eight rigor dimensions are adequately addressed, with clear ethical approvals, detailed methods, and appropriate statistical reporting. Minor copyediting issues and a few reporting clarifications (e.g., denominator for primary outcomes) are the only concerns.

Both reviewers independently scored all eight dimensions and agreed on 'pass' for each; the only minor divergence was on the power analysis sub-criterion (Reviewer 2 rated it 'reported but inadequate'), which does not change the overall dimension status. The statistics verification component checked 0 tests (none were machine-verifiable), so no statistical claims are independently confirmed beyond the reviewers' plausibility checks. The citation check found no retracted or unresolved references.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

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

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites multiple prior studies on the Ad26.ZEBOV, MVA-BN-Filo regimen in nonpregnant populations and notes the lack of data in pregnant women. The rationale for the study is logically derived from the high mortality of Ebola in pregnancy and the absence of vaccine safety data in this population. Limitations of prior research are implicitly addressed by the study's design to fill the gap in pregnant populations.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work cited and a logical rationale for the study.

Evidence

“Previous studies have found that the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen is well-tolerated and immunogenic, with mild-to-moderate adverse events (AEs) of short duration and no sequelae”

Introduction ¶2Find in source

“to date, no data are available on the safety, reactogenicity or immunogenicity of Ebola vaccination in pregnant populations”

Introduction ¶3Find in source

“The objective of the present study was to evaluate the safety, reactogenicity and immunogenicity of the two-dose Ebola vaccine regimen in healthy pregnant women in Rwanda.”

Introduction ¶3Find in source

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior research on Ebola vaccine safety and immunogenicity, and the rationale for studying pregnant women is well-justified.

Evidence

“Previous studies have found that the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen is well-tolerated and immunogenic, with mild-to-moderate adverse events (AEs) of short duration and no sequelae”

Introduction ¶2Find in source

“However, to date, no data are available on the safety, reactogenicity or immunogenicity of Ebola vaccination in pregnant populations”

Introduction ¶3Find in source

“The objective of the present study was to evaluate the safety, reactogenicity and immunogenicity of the two-dose Ebola vaccine regimen in healthy pregnant women in Rwanda.”

Introduction ¶3Find in source

Randomization method (Excel RNG) and unit (individual woman) are stated. Blinding is described as open-label with a rationale. Power analysis is not a formal hypothesis test but sample size justification is provided. Inclusion/exclusion criteria are detailed. Outlier handling is addressed through missing data and analysis population definitions. Controls are the unvaccinated group B. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous with clear randomization, blinding rationale, and pre-specified analysis populations.

Evidence

“An allocation template was created by coauthor S.A. at Emory University using simple randomization based on the Microsoft Excel random number generator function.”

MethodsFind in source

“There was no masking in this study. An open-label design was selected so that group B women could receive the benefits of the vaccine regimen.”

MethodsFind in source

“A target sample size of 1,000 participants in group A and 1,000 participants in group B was determined based on feasibility and the estimated background incidence of key pregnancy outcomes.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is rigorous for a phase 3 trial, with clear randomization, predefined inclusion/exclusion criteria, and a pre-specified analysis population, though blinding is absent (open-label) with a stated rationale.

Evidence

“An allocation template was created by coauthor S.A. at Emory University using simple randomization based on the Microsoft Excel random number generator function.”

MethodsFind in source

“There was no masking in this study. An open-label design was selected so that group B women could receive the benefits of the vaccine regimen.”

MethodsFind in source

“The study is not powered for any formal statistical hypothesis testing. A target sample size of 1,000 participants in group A and 1,000 participants in group B was determined based on feasibility and the estimated background incidence of key pregnancy outcomes.”

Statistical analysisFind in source

Sex of infants is reported, and all women are female by design. Age, weight, and health status are reported for women; gestational age, birth weight, and Apgar scores for infants. Demographics including race and HIV status are reported. Species/strain and housing are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for both mothers and infants.

Evidence

“Female | 504 (52.3%) | 497 (50.7%) | 1001 (51.5%)”

Table 1Find in source

“Age, year, median (Q1; Q3) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0)”

Table 1Find in source

“Race—Black | 992 (100%) | 1,020 (100%) | 2,012 (100%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well-reported for a human trial, including sex, age, weight, and demographics; species/strain and housing are not applicable.

Evidence

“Age, year, median (Q1; Q3) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0)”

Table 1Find in source

paraphrase[Table 1]

“Sex | Female | 504 (52.3%) | 497 (50.7%) | 1001 (51.5%)”

The protocol was approved by the Rwanda National Ethics Committee, Rwanda FDA, and Emory University IRB, with protocol numbers. Written informed consent was obtained. Regulatory compliance is stated. All applicable criteria are met.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly documented with named committees and informed consent.

Evidence

“The protocol was approved by the Rwanda National Ethics Committee (821/RNEC/2020), the Rwanda FDA (003/CT/RWANDA FDA/2020) and the Emory University Institutional Review Board (STUDY00000367).”

MethodsFind in source

“Written informed consent to participate was obtained.”

MethodsFind in source

“The study complies with all relevant ethical regulations.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented with named ethics committees and informed consent; regulatory compliance is stated.

Evidence

“The protocol was approved by the Rwanda National Ethics Committee (821/RNEC/2020), the Rwanda FDA (003/CT/RWANDA FDA/2020) and the Emory University Institutional Review Board (STUDY00000367).”

MethodsFind in source

“Written informed consent to participate was obtained.”

MethodsFind in source

The vaccines (Ad26.ZEBOV, MVA-BN-Filo) are named with manufacturer and dose. The FANG ELISA is identified. Statistical software (SAS v9.4) is named. Other bench resources are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational vaccines are well identified, and the assay and software are specified.

Evidence

“Study vaccines were manufactured and provided under the responsibility of Janssen Vaccines and Prevention B.V.”

MethodsFind in source

“IgG binding antibodies against EBOV GP were measured using the validated and FDA-endorsed FANG ELISA, performed by Q2 Solutions Vaccine Testing Laboratory.”

MethodsFind in source

“Data were analyzed using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational vaccines are identified with manufacturer and dose; software tools are identified; other bench resources are not applicable.

Evidence

“Study vaccines were manufactured and provided under the responsibility of Janssen Vaccines and Prevention B.V. Ad26.ZEBOV is a nonreplicating monovalent vaccine that encodes the full-length GP from EBOV Mayinga.”

MethodsFind in source

“Data were analyzed using SAS v9.4.”

Statistical analysisFind in source

The study is descriptive with CIs, so exact p-values are not applicable. Effect sizes are reported as risk differences with CIs. Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks on reported percentages and counts show no inconsistencies.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with CIs reported and no formal hypothesis testing.

Evidence

“No formal statistical hypothesis testing was planned. To aid understanding of the uncertainty around the estimates, CIs for primary endpoint estimates and the risk differences between groups A and B were computed post hoc.”

Statistical analysisFind in source

“Percentage difference (group A–group B) % (95% CI)”

Table 2Find in source

“Adverse maternal/fetal outcomes of interest were reported in 51 of 977 (5.2%; 95% CI = 3.9–6.8%) women in group A and 73 of 1,000 (7.3%; 95% CI = 5.8–9.1%) women in group B.”

ResultsFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate for a large clinical trial, with CIs reported for primary endpoints; exact p-values are not reported as the study is descriptive, and mathematical plausibility checks are not applicable due to large N.

Evidence

“Adverse maternal/fetal outcomes of interest were reported in 51 of 977 (5.2%; 95% CI = 3.9–6.8%) women in group A and 73 of 1,000 (7.3%; 95% CI = 5.8–9.1%) women in group B.”

ResultsFind in source

“No formal statistical hypothesis testing was planned.”

Statistical analysisFind in source

The data availability statement names the YODA Project as the managed-access platform with conditions and timeframe. Code availability is also via YODA. Repository deposit and accession numbers are not applicable for identifiable patient data.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data and code availability are clearly stated with a concrete access mechanism via YODA.

Evidence

“requests for access to the CSRs and participant-level data, including individual participant-level data, can be submitted through the Yale Open Data Access (YODA) Project site at http://yoda.yale.edu”

Data availabilityFind in source

“Requests for access to the analytic code can be submitted through YODA Project site at http://yoda.yale.edu”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is clearly stated with a concrete access route via the YODA project; code availability is also provided through YODA.

Evidence

“Requests for access to the CSRs and participant-level data, including individual participant-level data, can be submitted through the Yale Open Data Access (YODA) Project site at http://yoda.yale.edu .”

Data availabilityFind in source

“Requests for access to the analytic code can be submitted through YODA Project site at http://yoda.yale.edu .”

Data availabilityFind in source

The trial is registered (NCT04556526). CONSORT checklist is mentioned. All outcomes are reported. Limitations are discussed. Conclusions are proportional. Funding and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, CONSORT checklist, and limitations discussed.

Evidence

“ClinicalTrials.gov registration: NCT04556526”

AbstractFind in source

“Supplementary Figs. 1–3, Supplementary Tables 1–6 and CONSORT checklist.”

Supplementary materialFind in source

“The data should be interpreted considering limitations. This is not a masked trial”

Discussion ¶5Find in source

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, reporting guideline adherence, limitations discussion, and funding/COI statements.

Evidence

“ClinicalTrials.gov registration: NCT04556526”

AbstractFind in source

“Supplementary Figs. 1–3, Supplementary Tables 1–6 and CONSORT checklist.”

Supplementary materialFind in source

“The data should be interpreted considering limitations. This is not a masked trial, although it should be noted that the labor and delivery staff do not know which group the women are in, which may have reduced assessment bias.”

Discussion ¶5Find in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 30 references by DOI: 28 verified — 2 no DOI (shown, not verified).

5 data/code links checked; 5 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported; an informed reader should weigh the minor reporting gaps (e.g., unexplained denominator of 977 for primary outcomes, lack of formal power analysis) and the copyedit issues, but none threaten the validity of the conclusions. No erratum is warranted for the identified issues, though clarifying the denominator and fixing typographical errors would improve the record.

1.
HIGHreporting
In Results, Primary outcomes, clarify why the denominator for group A is 977 rather than the FAS of 992 (e.g., exclusions for missing outcome data) and state this explicitly.
The unexplained denominator is an internal inconsistency that an informed reader will notice and could raise questions about the analysis population.
2.
HIGHreporting
In Methods, Statistical analysis, add a sentence explicitly stating that the reported CIs for risk differences are not adjusted for multiplicity, given the numerous primary outcomes.
The current statement about inflated type I error is clear but could be more explicit to prevent misinterpretation of the CIs.
3.
MEDIUMcopyedit
In Results, Primary outcomes, remove the extra closing parentheses after each percentage (e.g., '95% CI = 0.8–2.3%))' should be '95% CI = 0.8–2.3%)').
Typographical errors in reported statistics can undermine confidence in the accuracy of the data.
4.
MEDIUMcopyedit
In Abstract, rephrase the sentence about SAE frequencies to avoid ambiguity: 'Maternal/fetal SAE frequencies were 9.8% in group A and 9.0% in group B; neonatal/infant SAE frequencies were 21.9% in group A and 15.9% in group B.'
The current use of 'respectively' with two pairs is confusing and could be misread.
5.
MEDIUMreporting
In Results, Secondary outcomes, specify the exact number of women in the denominator for the antibody response range (99.2–100%).
Providing the denominator improves clarity and allows readers to assess the precision of the estimate.
6.
MEDIUMreporting
In Methods, Statistical analysis, clarify how missing data were handled in the denominators for primary outcomes (e.g., whether women with missing outcomes were excluded from the denominator).
The current text states 'Missing data were not imputed' but does not specify how missing outcomes affected the analysis population.
7.
MEDIUMreporting
In Methods, Randomization and masking, specify whether outcome assessors or adjudicators were blinded to group assignment, even though the trial was open-label.
Clarifying the blinding status of outcome assessors helps readers assess potential bias in outcome ascertainment.
8.
MEDIUMreporting
In Methods, Statistical analysis, add a statement about whether the study was powered for the secondary immunogenicity endpoint, as the sample size justification focuses on safety.
Readers need to know whether immunogenicity findings are adequately powered or exploratory.
9.
LOWreporting
In Results, Patient disposition, ensure consistent use of 'enrolled' and 'randomized' throughout the manuscript.
Inconsistent terminology can confuse readers about the exact study flow.
10.
LOWreporting
In Data availability, add a note about the specific conditions for accessing data through YODA, such as the review process and timeline.
Making the access route more concrete helps readers understand how to request data.
11.
LOWreporting
In Results, report the number of women screened but not enrolled for each exclusion reason to improve transparency of the screening process.
Detailed screening data strengthen the transparency of the trial's conduct.
12.
LOWreporting
In Methods, Statistical analysis, clarify the role of the IDMC (Independent Data Monitoring Committee) in the statistical analysis section.
The IDMC is mentioned but its role in the analysis is not detailed, which could be clarified for completeness.

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Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

Read full text (PMC)

DOI

10.1038/s41591-025-03932-z

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Record fingerprint

746f7c37077a00a4db0d23377a57237dc21c61664d36d5c668668b35a05f00af

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

No reported statistical tests were found to recompute.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Overstated conclusions

None found

Checked — nothing surfaced.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work cited and a logical rationale for the study.

Evidence

“Previous studies have found that the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen is well-tolerated and immunogenic, with mild-to-moderate adverse events (AEs) of short duration and no sequelae”

Introduction ¶2Find in source

“to date, no data are available on the safety, reactogenicity or immunogenicity of Ebola vaccination in pregnant populations”

Introduction ¶3Find in source

“The objective of the present study was to evaluate the safety, reactogenicity and immunogenicity of the two-dose Ebola vaccine regimen in healthy pregnant women in Rwanda.”

Introduction ¶3Find in source

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior research on Ebola vaccine safety and immunogenicity, and the rationale for studying pregnant women is well-justified.

Evidence

“Previous studies have found that the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen is well-tolerated and immunogenic, with mild-to-moderate adverse events (AEs) of short duration and no sequelae”

Introduction ¶2Find in source

“However, to date, no data are available on the safety, reactogenicity or immunogenicity of Ebola vaccination in pregnant populations”

Introduction ¶3Find in source

“The objective of the present study was to evaluate the safety, reactogenicity and immunogenicity of the two-dose Ebola vaccine regimen in healthy pregnant women in Rwanda.”

Introduction ¶3Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous with clear randomization, blinding rationale, and pre-specified analysis populations.

Evidence

“An allocation template was created by coauthor S.A. at Emory University using simple randomization based on the Microsoft Excel random number generator function.”

MethodsFind in source

“There was no masking in this study. An open-label design was selected so that group B women could receive the benefits of the vaccine regimen.”

MethodsFind in source

“A target sample size of 1,000 participants in group A and 1,000 participants in group B was determined based on feasibility and the estimated background incidence of key pregnancy outcomes.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Evidence

“An allocation template was created by coauthor S.A. at Emory University using simple randomization based on the Microsoft Excel random number generator function.”

MethodsFind in source

“There was no masking in this study. An open-label design was selected so that group B women could receive the benefits of the vaccine regimen.”

MethodsFind in source

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for both mothers and infants.

Evidence

“Female | 504 (52.3%) | 497 (50.7%) | 1001 (51.5%)”

Table 1Find in source

“Age, year, median (Q1; Q3) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0)”

Table 1Find in source

“Race—Black | 992 (100%) | 1,020 (100%) | 2,012 (100%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well-reported for a human trial, including sex, age, weight, and demographics; species/strain and housing are not applicable.

Evidence

“Age, year, median (Q1; Q3) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0)”

Table 1Find in source

paraphrase[Table 1]

“Sex | Female | 504 (52.3%) | 497 (50.7%) | 1001 (51.5%)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly documented with named committees and informed consent.

Evidence

“The protocol was approved by the Rwanda National Ethics Committee (821/RNEC/2020), the Rwanda FDA (003/CT/RWANDA FDA/2020) and the Emory University Institutional Review Board (STUDY00000367).”

MethodsFind in source

“Written informed consent to participate was obtained.”

MethodsFind in source

“The study complies with all relevant ethical regulations.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented with named ethics committees and informed consent; regulatory compliance is stated.

Evidence

“The protocol was approved by the Rwanda National Ethics Committee (821/RNEC/2020), the Rwanda FDA (003/CT/RWANDA FDA/2020) and the Emory University Institutional Review Board (STUDY00000367).”

MethodsFind in source

“Written informed consent to participate was obtained.”

MethodsFind in source

The vaccines (Ad26.ZEBOV, MVA-BN-Filo) are named with manufacturer and dose. The FANG ELISA is identified. Statistical software (SAS v9.4) is named. Other bench resources are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational vaccines are well identified, and the assay and software are specified.

Evidence

“Study vaccines were manufactured and provided under the responsibility of Janssen Vaccines and Prevention B.V.”

MethodsFind in source

“IgG binding antibodies against EBOV GP were measured using the validated and FDA-endorsed FANG ELISA, performed by Q2 Solutions Vaccine Testing Laboratory.”

MethodsFind in source

“Data were analyzed using SAS v9.4.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational vaccines are identified with manufacturer and dose; software tools are identified; other bench resources are not applicable.

Evidence

MethodsFind in source

“Data were analyzed using SAS v9.4.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with CIs reported and no formal hypothesis testing.

Evidence

Statistical analysisFind in source

“Percentage difference (group A–group B) % (95% CI)”

Table 2Find in source

“Adverse maternal/fetal outcomes of interest were reported in 51 of 977 (5.2%; 95% CI = 3.9–6.8%) women in group A and 73 of 1,000 (7.3%; 95% CI = 5.8–9.1%) women in group B.”

ResultsFind in source

PASSReviewer 2· 85% conf

Evidence

“Adverse maternal/fetal outcomes of interest were reported in 51 of 977 (5.2%; 95% CI = 3.9–6.8%) women in group A and 73 of 1,000 (7.3%; 95% CI = 5.8–9.1%) women in group B.”

ResultsFind in source

“No formal statistical hypothesis testing was planned.”

Statistical analysisFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data and code availability are clearly stated with a concrete access mechanism via YODA.

Evidence

Data availabilityFind in source

“Requests for access to the analytic code can be submitted through YODA Project site at http://yoda.yale.edu”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is clearly stated with a concrete access route via the YODA project; code availability is also provided through YODA.

Evidence

Data availabilityFind in source

“Requests for access to the analytic code can be submitted through YODA Project site at http://yoda.yale.edu .”

Data availabilityFind in source

The trial is registered (NCT04556526). CONSORT checklist is mentioned. All outcomes are reported. Limitations are discussed. Conclusions are proportional. Funding and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, CONSORT checklist, and limitations discussed.

Evidence

“ClinicalTrials.gov registration: NCT04556526”

AbstractFind in source

“Supplementary Figs. 1–3, Supplementary Tables 1–6 and CONSORT checklist.”

Supplementary materialFind in source

“The data should be interpreted considering limitations. This is not a masked trial”

Discussion ¶5Find in source

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, reporting guideline adherence, limitations discussion, and funding/COI statements.

Evidence

“ClinicalTrials.gov registration: NCT04556526”

AbstractFind in source

“Supplementary Figs. 1–3, Supplementary Tables 1–6 and CONSORT checklist.”

Supplementary materialFind in source

Discussion ¶5Find in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 30 references by DOI: 28 verified — 2 no DOI (shown, not verified).

5 data/code links checked; 5 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
In Results, Primary outcomes, clarify why the denominator for group A is 977 rather than the FAS of 992 (e.g., exclusions for missing outcome data) and state this explicitly.
The unexplained denominator is an internal inconsistency that an informed reader will notice and could raise questions about the analysis population.
2.
HIGHreporting
In Methods, Statistical analysis, add a sentence explicitly stating that the reported CIs for risk differences are not adjusted for multiplicity, given the numerous primary outcomes.
The current statement about inflated type I error is clear but could be more explicit to prevent misinterpretation of the CIs.
3.
MEDIUMcopyedit
In Results, Primary outcomes, remove the extra closing parentheses after each percentage (e.g., '95% CI = 0.8–2.3%))' should be '95% CI = 0.8–2.3%)').
Typographical errors in reported statistics can undermine confidence in the accuracy of the data.
4.
MEDIUMcopyedit
In Abstract, rephrase the sentence about SAE frequencies to avoid ambiguity: 'Maternal/fetal SAE frequencies were 9.8% in group A and 9.0% in group B; neonatal/infant SAE frequencies were 21.9% in group A and 15.9% in group B.'
The current use of 'respectively' with two pairs is confusing and could be misread.
5.
MEDIUMreporting
In Results, Secondary outcomes, specify the exact number of women in the denominator for the antibody response range (99.2–100%).
Providing the denominator improves clarity and allows readers to assess the precision of the estimate.
6.
MEDIUMreporting
In Methods, Statistical analysis, clarify how missing data were handled in the denominators for primary outcomes (e.g., whether women with missing outcomes were excluded from the denominator).
The current text states 'Missing data were not imputed' but does not specify how missing outcomes affected the analysis population.
7.
MEDIUMreporting
In Methods, Randomization and masking, specify whether outcome assessors or adjudicators were blinded to group assignment, even though the trial was open-label.
Clarifying the blinding status of outcome assessors helps readers assess potential bias in outcome ascertainment.
8.
MEDIUMreporting
In Methods, Statistical analysis, add a statement about whether the study was powered for the secondary immunogenicity endpoint, as the sample size justification focuses on safety.
Readers need to know whether immunogenicity findings are adequately powered or exploratory.
9.
LOWreporting
In Results, Patient disposition, ensure consistent use of 'enrolled' and 'randomized' throughout the manuscript.
Inconsistent terminology can confuse readers about the exact study flow.
10.
LOWreporting
In Data availability, add a note about the specific conditions for accessing data through YODA, such as the review process and timeline.
Making the access route more concrete helps readers understand how to request data.
11.
LOWreporting
In Results, report the number of women screened but not enrolled for each exclusion reason to improve transparency of the screening process.
Detailed screening data strengthen the transparency of the trial's conduct.
12.
LOWreporting
In Methods, Statistical analysis, clarify the role of the IDMC (Independent Data Monitoring Committee) in the statistical analysis section.
The IDMC is mentioned but its role in the analysis is not detailed, which could be clarified for completeness.

Full text (78,367 chars · analyzed ~96%, head + tail)Analyzed: Aug 15, 2026