Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

Name: Kaimen Rigor review — Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.
Item: Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.
Rating: 59
Author: Alpha1

Malkin E, Zaric M, Kieh M, Baden LR, Fitz-Patrick D, Marini A, Yun H, Hayes P, Bromell R, Ayorinde M, Fernandez N, Varma R, Sigei F, Ward M, Pindolia H, Sewell S, Amini F, Blie J, Wilson B, Faley P, McCullough J, Tokpah F, Wisseh C, Towalid E, Hadawale S, Sayeed E, Hunt D, Keshavarzi N, Barin B, Maljkovic Berry I, Parks CL, Truter SG, Walker K, Vekemans J, Lehrman J, Engelbrecht M, Malherbe M, Laufer D, Philiponis V, Higgs E, Mutua G, Fast PE, Gupta SB, rVSVΔG-LASV-GPC Study Group

Paper source

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Kaimen Rigor review — 3.5★ (Adequate), 0 critical, 3 high issues for “Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.”

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Alpha1 Editorial

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

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Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

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DOI

10.1056/NEJMoa2501073

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8f1d47ef66cf20b5a238615470bc6763e9140e7a3d3c25fd3c9fefc1b76d4b4c

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Issued Aug 15, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

Paper source

Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

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

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
IntegrityIntegrity concern−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
20% does not match the reported count 2/20
“20.0% (2/20)”
Vaccine Safety and ReactogenicityFind in source

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 204DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 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.

This Phase 1 trial is methodologically sound with clear randomization, blinding, and appropriate statistical reporting for an early-phase study. The main weaknesses are missing explicit ethics committee details, informed consent description, and a data availability statement, along with minor reporting gaps such as unspecified statistical software and randomization method.

Both reviewers agreed on study type (interventional) and on most dimensions; they diverged on ethical approvals (pass vs. warn), where the more conservative warn was adopted due to missing explicit IRB name and informed consent. The statistics verification component checked only 1 test (inconsistent), so statistical correctness beyond that is unverified.

Numerical inconsistencies

2 findings · worst high

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.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Internal contradictions in the reported numbersAssessed

1 reported summary statistic mathematically impossible for the stated N (PERCENT).

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.

5 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

2 findings · worst medium

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.

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

The introduction cites prior work on Lassa fever outbreaks, the absence of approved vaccines, and the development of rVSVΔG-LASV-GPC, including its 100% efficacy in non-human primates. The rationale for the study is logically linked to the need for a vaccine and the promising preclinical data. The paper does not explicitly discuss limitations of prior research, but the premise is well-established.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on Lassa fever, the lack of approved vaccines, and the development of the rVSV vector platform, including the licensed ERVEBO vaccine.

Evidence

“No vaccines are approved for Lassa fever to alleviate health and economic burdens or to prepare for pandemics.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 2]

“rVSVΔG-LASV-GPC, developed at the Public Health Agency of Canada, demonstrated 100% efficacy in non-human primates and other models.”

“This first-in-human study of rVSVΔG-LASV-GPC was designed to assess safety and immunogenicity in healthy US and Liberian adults.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on Lassa fever, the rVSV platform, and the vaccine candidate's preclinical efficacy, and logically links this to the study objectives.

Evidence

“No vaccines are approved for Lassa fever to alleviate health and economic burdens or to prepare for pandemics.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 2]

“rVSVΔG-LASV-GPC, developed at the Public Health Agency of Canada, demonstrated 100% efficacy in non-human primates and other models.”

“This first-in-human study of rVSVΔG-LASV-GPC was designed to assess safety and immunogenicity in healthy US and Liberian adults.”

Introduction ¶2Find in source

The trial is randomized, double-blind, and placebo-controlled with a 4:1 randomization ratio. Randomization and blinding are described, and the unit of randomization is the participant. Inclusion/exclusion criteria are mentioned but not fully detailed in the main text. The study was not powered for formal hypothesis testing, which is appropriate for a Phase 1 trial. Outlier handling is not explicitly described, but the analysis population is defined.

Sub-criteria

controlsADEQUATE

power analysisN/A

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionINADEQUATE

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 randomization, blinding, dose escalation, and clear inclusion/exclusion criteria, though the power analysis is not applicable as it is a Phase 1 trial.

Evidence

“This randomized, double-blind, placebo-controlled, dose-escalation, phase 1 study evaluated the safety, tolerability, and immunogenicity of rVSVΔG-LASV-GPC.”

MethodsFind in source

“Healthy participants, aged 18-50 years, from 3 US and 1 Liberian sites were enrolled in eight groups and randomized (4:1) to intramuscular rVSV∆G-LASV-GPC or placebo (matched diluent).”

MethodsFind in source

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The trial design is rigorous with randomization, blinding, and a clear dose-escalation schema, though some details (e.g., randomization method) are not fully described in the main text.

Evidence

“This randomized, double-blind, placebo-controlled, dose-escalation, phase 1 study evaluated the safety, tolerability, and immunogenicity of rVSVΔG-LASV-GPC.”

MethodsFind in source

“randomized (4:1) to intramuscular rVSV∆G-LASV-GPC or placebo (matched diluent).”

MethodsFind in source

paraphrase[Methods, Trial design and oversight]

“Institutional Review, eligibility criteria and enrollment are detailed in the [supplement].”

The paper reports sex (31 female, 22 male in US; 32 female, 29 male in Liberia) and age (median 26 and 24 years). Health status is implied by inclusion criteria (healthy adults). Demographics are summarized in tables. Species/strain and housing conditions are not applicable as this is 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

Sex, age, and health status are reported for participants, and demographics are provided for both US and Liberian cohorts.

Evidence

paraphrase[Results, Participants]

“Of 80 US volunteers screened, 53 (31 female, 22 male) were enrolled, median age 26 years (range: 18-49).”

paraphrase[Results, Participants]

“Of 175 Liberian volunteers screened, 61 (32 female, 29 male) were enrolled, median age 24 years (range: 18-43).”

PASSReviewer 2· 90% conf

Sex, age, and health status are reported for participants; demographics are adequately described.

Evidence

paraphrase[Results, Participants]

“Of 80 US volunteers screened, 53 (31 female, 22 male) were enrolled, median age 26 years (range: 18-49).”

paraphrase[Results, Participants]

“Of 175 Liberian volunteers screened, 61 (32 female, 29 male) were enrolled, median age 24 years (range: 18-43).”

The paper states 'US FDA and the Liberia Medicine and Health Regulatory Authority Investigational New Drug authorizations, Institutional Review' but does not name a specific IRB or ethics committee. Informed consent is not explicitly described in the main text, though it is implied by the conduct of the trial. Regulatory compliance is mentioned via FDA and Liberian authority authorizations.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial was approved by institutional review boards and regulatory authorities, and informed consent is implied; however, the specific ethics committee names are not provided in the main text.

Evidence

paraphrase[Methods, Trial design and oversight]

“Randomization, blinding, US FDA and the Liberia Medicine and Health Regulatory Authority Investigational New Drug authorizations, Institutional Review, eligibility criteria and enrollment are detailed in the [Supplementary Appendix].”

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

WARNReviewer 2· 80% conf

The paper mentions regulatory authorizations and trial registration, but does not explicitly name an IRB/ethics committee that approved the study or describe informed consent in the main text.

Evidence

paraphrase[Methods, Trial design and oversight]

“US FDA and the Liberia Medicine and Health Regulatory Authority Investigational New Drug authorizations, Institutional Review, eligibility criteria and enrollment are detailed in the [supplement].”

absence[Methods]

Informed consent is not described in the main text.

The vaccine candidate rVSVΔG-LASV-GPC is named, and its manufacture is referenced. The ELISA kit (ReLASV® Pan-Lassa NP IgG/IgM ELISA Kit, Zalgen Labs) is identified. Assays for neutralizing antibodies and T-cell responses are described. Software tools are not explicitly identified, but statistical methods are described.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational vaccine and key reagents are identified, including the ELISA kit and assay details, though some specifics like lot numbers are not provided.

Evidence

paraphrase[Abstract]

“A replication-competent recombinant vesicular stomatitis virus vectored vaccine encoding a Lassa Virus (LASV) glycoprotein complex (rVSVΔG-LASV-GPC) has been developed.”

paraphrase[Methods, LASV Nucleoprotein (NP) IgM and IgG ELISA]

“ReLASV® Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) was used following manufacturer’s instructions.”

PASSReviewer 2· 85% conf

The investigational vaccine and key reagents are identified, though some details (e.g., lot numbers) are not provided.

Evidence

“rVSVΔG-LASV-GPC”

AbstractFind in source

paraphrase[Methods, LASV Nucleoprotein (NP) IgM and IgG ELISA]

“ReLASV® Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) was used following manufacturer’s instructions.”

The paper reports geometric means with 95% CIs for antibody responses, which is appropriate. It does not report p-values for primary endpoints, but this is consistent with a descriptive Phase 1 study. The statistical software is not identified. Data presentation includes figures with individual data points and error bars defined as 95% CIs. Mathematical plausibility checks were not performed due to lack of raw data.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedN/A

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate for a Phase 1 trial, with geometric means and 95% CIs reported; exact p-values are not reported, but the study was not powered for hypothesis testing.

Evidence

“Binding and neutralizing antibody levels were summarized by geometric mean (GM) and 95% confidence interval (CI).”

Statistical analysisFind in source

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate for a Phase 1 trial, with geometric means and 95% CIs reported; exact p-values are not reported, but the study was not powered for hypothesis testing.

Evidence

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

“Binding and neutralizing antibody levels were summarized by geometric mean (GM) and 95% confidence interval (CI).”

Statistical analysisFind in source

There is no explicit data availability statement in the paper. The trial is registered, but individual patient data are not deposited in a public repository. The paper mentions that the protocol is available at NEJM.org, but this does not constitute a data availability statement. No code sharing is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

The paper does not include a data availability statement, and no data or code repositories are mentioned.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

The paper does not include a data availability statement, and no data or code repositories are mentioned.

Evidence

absence[Entire paper]

No data availability statement is present.

The methods are detailed enough for replication, including dosing, assays, and statistical analysis. The trial is registered (NCT04794218). Limitations are discussed in the Discussion section. Conclusions are proportional to the evidence. Funding sources and conflict of interest are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports methods in detail, discusses limitations, and provides funding and conflict of interest information; trial registration is provided.

Evidence

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

“Study limitations warrant comment. This was a Phase 1 study and hypothesis testing was not performed.”

Discussion ¶7Find in source

paraphrase[Support Statement]

“This Phase 1 trial (ClinicalTrials.gov number NCT04794218) was funded by Coalition for Epidemic Preparedness Innovations (CEPI) (award reference number: 276869).”

PASSReviewer 2· 85% conf

The paper is transparent about methods, limitations, and funding, and reports all outcomes, though it does not reference a specific reporting guideline.

Evidence

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

“Study limitations warrant comment. This was a Phase 1 study and hypothesis testing was not performed.”

DiscussionFind in source

Registered (2 IDs: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 38 references by DOI: 37 verified — 1 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is generally robust, but readers should weigh the missing explicit ethics committee details and informed consent description, and the lack of a data availability statement. The internal contradiction regarding participant counts (114 randomized vs. 113 vaccinated) is minor but should be clarified. No erratum is urgently required, but a data availability statement and ethics details would strengthen transparency.

1.
HIGHethics
In the Methods section, explicitly name the institutional review board(s) that approved the study and provide approval numbers.
The current text only mentions 'Institutional Review' without specifics, which is a reporting gap for a clinical trial.
2.
HIGHethics
Add a statement describing the informed consent process (e.g., written informed consent obtained from all participants) in the Methods.
Informed consent is a fundamental ethical requirement and its absence from the main text is a notable omission.
3.
HIGHdata code
Add a data availability statement specifying how de-identified data can be accessed (e.g., via a data-sharing agreement or repository like Vivli).
The paper currently lacks any data availability statement, which is expected for a data-driven clinical trial.
4.
MEDIUMreporting
In the Statistical analysis section, identify the statistical software used (e.g., SAS, R) with version numbers.
Software identification aids reproducibility and is a standard reporting expectation.
5.
MEDIUMreporting
In the Methods, describe the randomization method (e.g., computer-generated random sequence) and allocation concealment.
The current text states randomization but not the method, which is a common reviewer request.
6.
MEDIUMreporting
Detail the inclusion/exclusion criteria in the main text rather than only referring to the supplement.
Full eligibility criteria are important for readers to assess generalizability.
7.
MEDIUMreporting
Reference the CONSORT reporting guideline in the Methods or provide a completed CONSORT checklist as supplementary material.
Adherence to reporting guidelines improves transparency and completeness.
8.
MEDIUMstatistics
Clarify the discrepancy between the abstract stating 114 participants randomized and the results reporting 113 who received vaccine (one ineligible post-randomization).
The internal contradiction could confuse readers and should be explicitly reconciled.
9.
MEDIUMreporting
State how outliers were handled in the statistical analysis, if any, or explicitly state that no outliers were excluded.
Outlier handling is a methodological detail that should be transparent.
10.
LOWcopyedit
Ensure consistent use of the vaccine name 'rVSVΔG-LASV-GPC' throughout the manuscript, including the delta symbol (Δ vs ∆).
Inconsistent terminology can confuse readers and appears unprofessional.
11.
LOWcopyedit
Rephrase the sentence in Methods, Trial design and oversight: 'The assignment into Group 4A occurred for participants declining second dose or to balance the overall group sizes between Group 4A and 4B.' for clarity.
The current phrasing is awkward and could be misinterpreted.
12.
LOWcopyedit
Add a comma after 'events' in the sentence 'Two (4.2%) Liberian vaccinees reported Grade 3 systemic events, abdominal pain/diarrhea and fever, for 1-2 days.'
Minor punctuation improves readability.

Full text (28,297 chars)Analyzed: Aug 15, 2026

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Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

Read full text (PMC)

DOI

10.1056/NEJMoa2501073

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8f1d47ef66cf20b5a238615470bc6763e9140e7a3d3c25fd3c9fefc1b76d4b4c

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

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
IntegrityIntegrity concern−0.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
20% does not match the reported count 2/20
“20.0% (2/20)”
Vaccine Safety and ReactogenicityFind in source

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 204DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit4 minor suggestions

Numerical inconsistencies

2 findings · worst high

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Internal contradictions in the reported numbersAssessed

1 reported summary statistic mathematically impossible for the stated N (PERCENT).

Overstated conclusions

None found

Checked — nothing surfaced.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

2 findings · worst medium

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“No vaccines are approved for Lassa fever to alleviate health and economic burdens or to prepare for pandemics.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 2]

“rVSVΔG-LASV-GPC, developed at the Public Health Agency of Canada, demonstrated 100% efficacy in non-human primates and other models.”

“This first-in-human study of rVSVΔG-LASV-GPC was designed to assess safety and immunogenicity in healthy US and Liberian adults.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

Evidence

“No vaccines are approved for Lassa fever to alleviate health and economic burdens or to prepare for pandemics.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 2]

“rVSVΔG-LASV-GPC, developed at the Public Health Agency of Canada, demonstrated 100% efficacy in non-human primates and other models.”

“This first-in-human study of rVSVΔG-LASV-GPC was designed to assess safety and immunogenicity in healthy US and Liberian adults.”

Introduction ¶2Find in source

Sub-criteria

controlsADEQUATE

power analysisN/A

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionINADEQUATE

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 randomization, blinding, dose escalation, and clear inclusion/exclusion criteria, though the power analysis is not applicable as it is a Phase 1 trial.

Evidence

“This randomized, double-blind, placebo-controlled, dose-escalation, phase 1 study evaluated the safety, tolerability, and immunogenicity of rVSVΔG-LASV-GPC.”

MethodsFind in source

“Healthy participants, aged 18-50 years, from 3 US and 1 Liberian sites were enrolled in eight groups and randomized (4:1) to intramuscular rVSV∆G-LASV-GPC or placebo (matched diluent).”

MethodsFind in source

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The trial design is rigorous with randomization, blinding, and a clear dose-escalation schema, though some details (e.g., randomization method) are not fully described in the main text.

Evidence

“This randomized, double-blind, placebo-controlled, dose-escalation, phase 1 study evaluated the safety, tolerability, and immunogenicity of rVSVΔG-LASV-GPC.”

MethodsFind in source

“randomized (4:1) to intramuscular rVSV∆G-LASV-GPC or placebo (matched diluent).”

MethodsFind in source

paraphrase[Methods, Trial design and oversight]

“Institutional Review, eligibility criteria and enrollment are detailed in the [supplement].”

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

Sex, age, and health status are reported for participants, and demographics are provided for both US and Liberian cohorts.

Evidence

paraphrase[Results, Participants]

“Of 80 US volunteers screened, 53 (31 female, 22 male) were enrolled, median age 26 years (range: 18-49).”

paraphrase[Results, Participants]

“Of 175 Liberian volunteers screened, 61 (32 female, 29 male) were enrolled, median age 24 years (range: 18-43).”

PASSReviewer 2· 90% conf

Sex, age, and health status are reported for participants; demographics are adequately described.

Evidence

paraphrase[Results, Participants]

“Of 80 US volunteers screened, 53 (31 female, 22 male) were enrolled, median age 26 years (range: 18-49).”

paraphrase[Results, Participants]

“Of 175 Liberian volunteers screened, 61 (32 female, 29 male) were enrolled, median age 24 years (range: 18-43).”

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial was approved by institutional review boards and regulatory authorities, and informed consent is implied; however, the specific ethics committee names are not provided in the main text.

Evidence

paraphrase[Methods, Trial design and oversight]

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

WARNReviewer 2· 80% conf

The paper mentions regulatory authorizations and trial registration, but does not explicitly name an IRB/ethics committee that approved the study or describe informed consent in the main text.

Evidence

paraphrase[Methods, Trial design and oversight]

absence[Methods]

Informed consent is not described in the main text.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational vaccine and key reagents are identified, including the ELISA kit and assay details, though some specifics like lot numbers are not provided.

Evidence

paraphrase[Abstract]

“A replication-competent recombinant vesicular stomatitis virus vectored vaccine encoding a Lassa Virus (LASV) glycoprotein complex (rVSVΔG-LASV-GPC) has been developed.”

paraphrase[Methods, LASV Nucleoprotein (NP) IgM and IgG ELISA]

“ReLASV® Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) was used following manufacturer’s instructions.”

PASSReviewer 2· 85% conf

The investigational vaccine and key reagents are identified, though some details (e.g., lot numbers) are not provided.

Evidence

“rVSVΔG-LASV-GPC”

AbstractFind in source

paraphrase[Methods, LASV Nucleoprotein (NP) IgM and IgG ELISA]

“ReLASV® Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) was used following manufacturer’s instructions.”

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedN/A

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate for a Phase 1 trial, with geometric means and 95% CIs reported; exact p-values are not reported, but the study was not powered for hypothesis testing.

Evidence

“Binding and neutralizing antibody levels were summarized by geometric mean (GM) and 95% confidence interval (CI).”

Statistical analysisFind in source

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

PASSReviewer 2· 80% conf

Statistical methods are appropriate for a Phase 1 trial, with geometric means and 95% CIs reported; exact p-values are not reported, but the study was not powered for hypothesis testing.

Evidence

“This study was not powered for formal hypothesis testing and analyses were not adjusted for multiplicity.”

Statistical analysisFind in source

“Binding and neutralizing antibody levels were summarized by geometric mean (GM) and 95% confidence interval (CI).”

Statistical analysisFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

The paper does not include a data availability statement, and no data or code repositories are mentioned.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

The paper does not include a data availability statement, and no data or code repositories are mentioned.

Evidence

absence[Entire paper]

No data availability statement is present.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports methods in detail, discusses limitations, and provides funding and conflict of interest information; trial registration is provided.

Evidence

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

“Study limitations warrant comment. This was a Phase 1 study and hypothesis testing was not performed.”

Discussion ¶7Find in source

paraphrase[Support Statement]

“This Phase 1 trial (ClinicalTrials.gov number NCT04794218) was funded by Coalition for Epidemic Preparedness Innovations (CEPI) (award reference number: 276869).”

PASSReviewer 2· 85% conf

The paper is transparent about methods, limitations, and funding, and reports all outcomes, though it does not reference a specific reporting guideline.

Evidence

“Trial reg: NCT04794218 (https://clinicaltrials.gov/ct2/show/NCT04794218)”

AbstractFind in source

“Study limitations warrant comment. This was a Phase 1 study and hypothesis testing was not performed.”

DiscussionFind in source

Registered (2 IDs: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 38 references by DOI: 37 verified — 1 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHethics
In the Methods section, explicitly name the institutional review board(s) that approved the study and provide approval numbers.
The current text only mentions 'Institutional Review' without specifics, which is a reporting gap for a clinical trial.
2.
HIGHethics
Add a statement describing the informed consent process (e.g., written informed consent obtained from all participants) in the Methods.
Informed consent is a fundamental ethical requirement and its absence from the main text is a notable omission.
3.
HIGHdata code
Add a data availability statement specifying how de-identified data can be accessed (e.g., via a data-sharing agreement or repository like Vivli).
The paper currently lacks any data availability statement, which is expected for a data-driven clinical trial.
4.
MEDIUMreporting
In the Statistical analysis section, identify the statistical software used (e.g., SAS, R) with version numbers.
Software identification aids reproducibility and is a standard reporting expectation.
5.
MEDIUMreporting
In the Methods, describe the randomization method (e.g., computer-generated random sequence) and allocation concealment.
The current text states randomization but not the method, which is a common reviewer request.
6.
MEDIUMreporting
Detail the inclusion/exclusion criteria in the main text rather than only referring to the supplement.
Full eligibility criteria are important for readers to assess generalizability.
7.
MEDIUMreporting
Reference the CONSORT reporting guideline in the Methods or provide a completed CONSORT checklist as supplementary material.
Adherence to reporting guidelines improves transparency and completeness.
8.
MEDIUMstatistics
Clarify the discrepancy between the abstract stating 114 participants randomized and the results reporting 113 who received vaccine (one ineligible post-randomization).
The internal contradiction could confuse readers and should be explicitly reconciled.
9.
MEDIUMreporting
State how outliers were handled in the statistical analysis, if any, or explicitly state that no outliers were excluded.
Outlier handling is a methodological detail that should be transparent.
10.
LOWcopyedit
Ensure consistent use of the vaccine name 'rVSVΔG-LASV-GPC' throughout the manuscript, including the delta symbol (Δ vs ∆).
Inconsistent terminology can confuse readers and appears unprofessional.
11.
LOWcopyedit
Rephrase the sentence in Methods, Trial design and oversight: 'The assignment into Group 4A occurred for participants declining second dose or to balance the overall group sizes between Group 4A and 4B.' for clarity.
The current phrasing is awkward and could be misinterpreted.
12.
LOWcopyedit
Add a comma after 'events' in the sentence 'Two (4.2%) Liberian vaccinees reported Grade 3 systemic events, abdominal pain/diarrhea and fever, for 1-2 days.'
Minor punctuation improves readability.

Full text (28,297 chars)Analyzed: Aug 15, 2026