Rigor Reviewed

Rigor-Reviewed Manuscript

Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

Name: Adcurare Rigor Record — Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.
Item: Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.
Rating: 59
Author: Adcurare

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

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Adcurare Rigor Review — 3.5★ (Adequate), 0 critical, 9 high issues for “Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability not met−0.5★
ReportingStudy design partially met−0.25★
ReportingEthical approvals partially met−0.25★
ReportingKey resources partially met−0.25★
ReportingStatistical analysis partially met−0.25★

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

Not verified in this report

No reported statistical tests were found to recompute.

Problems surfaced5 types

Data and code not shared
Statistical reporting gaps (tests, assumptions, effect sizes)
Ethics/consent reporting incomplete
Key resources under-identified (antibodies, cell lines, RRIDs)
Study-design details incomplete (controls, blinding, power)

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.

The manuscript reports a well-designed Phase 1 Lassa vaccine trial with a clear scientific premise, adequate reporting of biological variables, and good transparency overall. However, it has significant reporting gaps in ethical approvals (no named IRB, no informed consent statement), key resources (statistical software not identified), statistical analysis (tests named inadequately, no exact p-values), and a critical omission of a data availability statement.

All three independent reviewers were provided with the same full manuscript text. They generally agreed on most dimensions, with minor divergence on key resources (R3 rated 'fail' citing cell line authentication; the other two rated 'warn'). The copyedit pass flagged 9 minor issues, primarily clarity and consistency. The citation check found no retracted or unfound references. The statistics verification could not recompute any tests (none met the criteria for recomputation), so neither errors nor correctness were assessed.

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

Reporting

Eight Dimensions3 pass · 4 warn · 1 fail

The introduction cites prior work on Lassa fever epidemiology, the rVSV platform and its success as ERVEBO, and preclinical studies showing 100% efficacy in non-human primates. The rationale for the study is logically derived from this evidence. However, the paper does not explicitly address limitations of prior research, though this is a minor omission for a Phase 1 trial.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior work on Lassa fever burden, the success of the rVSV platform for Ebola, and preclinical efficacy data, with a logical rationale for the first-in-human study.

Evidence

paraphrase[Introduction]

“The introduction cites references on Lassa fever, the rVSV-Ebola vaccine (ERVEBO), and preclinical rVSV-LASV efficacy in non-human primates.”

direct quote[Introduction, last sentence]

“This first-in-human study of rVSV\u0394G-LASV-GPC was designed to assess safety and immunogenicity in healthy US and Liberian adults.”

absence[Introduction]

Limitations of prior studies are not explicitly discussed.

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing the unmet need for a Lassa fever vaccine, the success of the rVSV vector platform for Ebola, and prior preclinical data for the candidate.

Evidence

direct quote[Introduction, paragraph 1-2]

“A consortium led by International Aids Vaccine Initiative (IAVI) is advancing a Lassa fever vaccine based on replication-competent recombinant vesicular stomatitis virus (rVSV) vector with VSV envelope glycoprotein gene exchanged for LASV glycoprotein complex (LASV-GPC; rVSVΔG-LASV-GPC). Based on the same approach, Merck developed a rVSVΔG Zaire Ebola virus (ERVEBO) chimera, approved by FDA, EMA, and African countries.”

direct quote[Introduction, last sentence]

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

absence[Introduction]

Limitations of prior research are not addressed.

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific foundation by citing prior work on Lassa fever, the rVSV platform, and prior vaccine studies, and logically motivates the present study.

Evidence

paraphrase[Introduction]

“The introduction cites 21 references covering Lassa fever epidemiology, the rVSV Ebola vaccine success, and preclinical rVSV-LASV studies.”

direct quote[Introduction, last paragraph]

“Based on the same approach, Merck developed a rVSVΔG Zaire Ebola virus (ERVEBO) chimera, approved by FDA, EMA, and African countries.”

direct quote[Discussion, paragraph 7]

“Currently there are no defined correlates of protection against LASV infection, and the immunological thresholds required for vaccine efficacy remain undefined.”

The paper states participants were randomized and double-blind, but the randomization method (e.g., computer-generated) is not specified in the main text, only referenced to the supplementary appendix. No a priori power analysis is reported, which is expected for a Phase 1 safety study. Inclusion criteria are limited to age and healthy status; full criteria are in the supplementary. Outlier handling is not discussed. Blinding is described as double-blind, which is adequate. The unit of randomization (individual) is clear.

Sub-criteria

controlsN/A

power analysisNOT REPORTED

blinding levelsADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionINADEQUATE

randomization methodNOT REPORTED

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

The study design is adequately described as a randomized, double-blind, placebo-controlled trial with participant-level randomization and blinding, inclusion/exclusion criteria are defined, and the analysis population is described, though a power analysis was not performed (typical for phase 1) and outlier handling is vague.

Evidence

direct quote[Abstract]

“In this Phase 1, first-in-human, double-blind study, 114 healthy adults (18-50 years of age) were randomized to receive rVSV\u0394G-LASV-GPC or placebo intramuscularly”

direct quote[Methods, paragraph 1]

“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].”

direct quote[Statistical analysis section]

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

WARNReviewer 2· 85% conf

The trial design is described but several key methodological details are not fully reported in the main text, including the randomization method, power analysis, and outlier handling, and inclusion/exclusion criteria are only partially given.

Evidence

direct quote[Methods, Trial design and oversight]

“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).”

direct quote[Methods, Statistical analysis]

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

direct quote[Methods, Trial design and oversight]

“Healthy participants, aged 18-50 years, from 3 US and 1 Liberian sites were enrolled...”

WARNReviewer 3· 85% conf

The study design is generally rigorous (randomized, double-blind, placebo-controlled), but several methodological details are inadequately reported or missing, including the randomization method, a priori power analysis, and full inclusion/exclusion criteria in the main text.

Evidence

absence[Methods, Trial design and oversight]

Randomization method is not specified.

direct quote[Methods, Statistical analysis]

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

paraphrase[Methods, Trial design and oversight]

“Eligibility criteria are mentioned (healthy, 18-50 years) but details are referred to the protocol.”

The paper reports sex and age for both cohorts (e.g., 53 US participants: 31 female, 22 male, median age 26). Demographics are referenced in a table. Health status is described as 'healthy adults'. Weight is not reported, which is a minor omission for a Phase 1 trial that does not require weight-based dosing.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthINADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex, age, and health status are reported for both US and Liberian cohorts, but race/ethnicity is not reported in the main text (deferred to supplementary). This gives 2 of 3 applicable criteria as adequate, meeting the pass threshold.

Evidence

direct quote[Results]

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

direct quote[Results]

“The representativeness of the enrolled individuals is summarized in [Supplementary Appendix].”

direct quote[Methods]

“Healthy participants, aged 18-50 years, from 3 US and 1 Liberian sites were enrolled”

PASSReviewer 2· 90% conf

Sex and age are reported for both US and Liberian cohorts, and baseline demographics are summarized in a table. Health status is stated as 'healthy', but weight is not reported.

Evidence

direct quote[Results, Participants]

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

absence[Results, Participants]

Weight is not reported.

direct quote[Results, Participants]

“Table 1 summarizes participant demographics and characteristics.”

PASSReviewer 3· 80% conf

Sex and age are reported for US and Liberian cohorts, and health status is described; demographics are referenced to a table but not fully detailed in the main text, which is acceptable given the study design.

Evidence

direct quote[Results, Participants]

“Of 80 US volunteers screened, 53 (31 female, 22 male) were enrolled... 61 (32 female, 29 male) were enrolled.”

direct quote[Results, Participants]

“median age 26 years (range: 18-49)... median age 24 years (range: 18-43).”

paraphrase[Results, Participants]

“The representativeness of the enrolled individuals is summarized in [supplement].”

The methods mention 'Institutional Review' but no named board or approval number. Informed consent is not explicitly stated. Regulatory compliance with the Declaration of Helsinki or ICH-GCP is not referenced. Although the trial is registered (NCT04794218) and funded by CEPI, the ethical approvals statement is absent from the main text. According to the scoring rule, any applicable inadequate/not_reported sub-criterion warrants a warn.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementNOT REPORTED

regulatory complianceNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

The paper does not name a specific IRB/ethics committee that approved the study, does not mention informed consent, and does not reference a regulatory framework such as the Declaration of Helsinki. Since this is human-subjects research, these are notable reporting gaps.

Evidence

direct quote[Methods]

absence[Entire paper]

No mention of informed consent.

absence[Entire paper]

No reference to the Declaration of Helsinki or other regulatory framework.

WARNReviewer 2· 90% conf

The paper references ethical review and regulatory authorizations in the supplementary appendix but does not name the reviewing IRB or provide a protocol number in the main text, and informed consent is not mentioned.

Evidence

direct quote[Methods, Trial design and oversight]

absence[Methods]

Informed consent is not mentioned in the main text.

direct quote[Methods, Trial design and oversight]

“US FDA and the Liberia Medicine and Health Regulatory Authority Investigational New Drug authorizations”

WARNReviewer 3· 90% conf

The paper does not provide an explicit ethics approval statement (named IRB or ethics committee) or mention informed consent, though it references regulatory authorizations. This is a reporting gap but not evidence of misconduct.

Evidence

absence[Methods, Trial design and oversight]

No named IRB or ethics committee is cited for approval.

absence[Methods]

Informed consent is not mentioned.

paraphrase[Methods, Trial design and oversight]

“The authors mention FDA and Liberian regulatory authorizations but do not cite a specific guideline like Declaration of Helsinki.”

The vaccine (rVSVΔG-LASV-GPC) is described and its manufacture is referenced. Assay kits such as the ReLASV Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) and the International Standard for anti-LASV antibodies (NIBSC) are identified. Antibodies, cell lines, mycoplasma testing, and organisms are not applicable. Statistical software is not mentioned anywhere in the paper, which is a notable omission for reproducibility.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

The investigational vaccine and key assay reagents are identified, but the statistical software used for analysis is not reported. This gives 1 of 2 applicable sub-criteria as adequate, falling to a warn.

Evidence

direct quote[Methods]

“randomized (4:1) to intramuscular rVSV\u0394G-LASV-GPC or placebo (matched diluent).”

direct quote[Methods]

“ReLASV\u00ae Pan-Lassa NP IgG/IgM ELISA Kit (Zalgen Labs) was used following manufacturer\u2019s instructions”

absence[Statistical analysis section]

No statistical software is mentioned.

WARNReviewer 2· 80% conf

The investigational vaccine is identified by name, dose, and route, but the manufacturer is not explicitly stated in the main text. Statistical software is not identified.

Evidence

direct quote[Methods, Trial design and oversight]

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

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

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

absence[Methods, Statistical analysis]

Statistical software is not mentioned.

FAILReviewer 3· 80% conf

Critical reagents are inadequately identified: the vaccine product lacks lot number, cell lines used in assays are not authenticated, mycoplasma testing is absent, and software is not named. Only antibodies used in ELISA are adequately described.

Evidence

direct quote[Methods, LASV GPC-specific IgG ELISA]

“Anti-LASV-GPC serum IgG antibodies were quantified by ELISA using a standard curve (first International Standard of Anti-LASV Antibodies [National Institute for Biological Standards and Control, 20/202]).”

absence[Methods, Vaccine shedding and T-cell assays]

Cell line authentication and mycoplasma testing are not mentioned.

direct quote[Methods, Trial design and oversight]

“rVSVΔG-LASV-GPC vaccine or placebo (matched diluent).”

Tests are not named for primary analyses (descriptive only); a Spearman's rank test is mentioned for post-hoc correlations but no p-values are given. Assumptions such as normality or equal variance are not verified. Exact p-values are not reported. Statistical software is not identified. Effect sizes (geometric means) and CIs are reported adequately. Data presentation includes individual data points, error bars, and per-group n. Mathematical plausibility is not applicable given the non-integer continuous outcomes and descriptive focus.

Sub-criteria

tests namedINADEQUATE

exact p valuesNOT REPORTED

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The study reports effect sizes with 95% CIs and presents data adequately, but it does not name statistical tests for primary comparisons, verify assumptions, report exact p-values, or identify software. This results in 2 of 6 applicable criteria being adequate, which is a warn.

Evidence

direct quote[Statistical analysis section]

“Post-hoc correlation analyses used Spearman\u2019s rank test.”

direct quote[Results]

“Peak binding IgG levels, typically at day 85, were geometric means of 1400.8 (95% CI, 952.5-2060.0)”

absence[Statistical analysis section]

No statistical software is identified.

WARNReviewer 2· 85% conf

The analysis uses appropriate descriptive statistics (geometric means, 95% CIs) and a Spearman correlation test, but exact p-values are not reported, test assumptions are not verified, and the statistical software is not identified.

Evidence

direct quote[Methods, Statistical analysis]

“Post-hoc correlation analyses used Spearman’s rank test.”

absence[Methods, Statistical analysis]

Assumptions are not verified.

direct quote[Methods, Statistical analysis]

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

WARNReviewer 3· 85% conf

The statistical analysis is limited: only Spearman's rank test is named for post-hoc correlations, no hypothesis tests are performed, exact p-values are not reported, and software is not identified. However, effect sizes with CIs and individual data points are presented.

Evidence

direct quote[Methods, Statistical analysis]

“Post-hoc correlation analyses used Spearman’s rank test.”

absence[Results]

Exact p-values are not reported anywhere.

direct quote[Results, Immunogenicity]

“Geometric Means of 2258.4 (95% CI, 1177.7-4330.7)...”

No data availability statement is present in the paper. For patient-level data from a clinical trial, a data access statement is expected, even if controlled. Repository deposit and accession numbers are not applicable for identifiable patient data, and code sharing is not applicable as no bespoke analysis code is mentioned. Therefore, the only applicable sub-criterion is not reported.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 95% conf

The paper lacks a data availability statement, which is required for clinical trials. No repository deposit, accession numbers, or code sharing are applicable, but the absence of any statement results in a fail.

Evidence

absence[Entire paper]

No data availability statement is present.

FAILReviewer 2· 90% conf

The paper does not include a data availability statement, no data are deposited in a repository, and no code is shared. Only a clinical trial registration number is provided.

Evidence

absence[Methods (all sections)]

No data availability statement is present.

absence[Methods (all sections)]

No repository deposit is mentioned.

direct quote[Abstract, Methods, Support Statement]

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

FAILReviewer 3· 95% conf

No data availability statement, repository deposit, accession numbers for data, or code sharing are provided. The clinical trial registration number is given but does not constitute data access.

Evidence

absence[Entire paper]

No data availability statement is present.

absence[Methods or Data Availability]

No repository deposit mentioned.

direct quote[Abstract, last line]

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

Methods are detailed (though some details are in supplementary). Trial registration number is provided (NCT04794218). All prespecified outcomes (safety, immunogenicity) are reported with both positive and negative results. Limitations are discussed. Conclusions are proportional. Funding and conflicts of interest are stated. A CONSORT flow diagram or similar reporting guideline is not referenced.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports methods adequately, registers the trial, describes all outcomes, discusses limitations, draws proportional conclusions, and includes funding/COI statements. Only a reporting guideline (e.g., CONSORT) is not mentioned, which is a common omission but does not prevent a pass.

Evidence

direct quote[Abstract]

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

direct quote[Discussion]

“Study limitations warrant comment. This was a Phase 1 study and hypothesis testing was not performed. It included a relatively small sample, among whom several US participants were lost to follow-up and a few participants in Liberia had pre-existing antibodies to LASV.”

direct quote[Support statement and disclosure]

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

PASSReviewer 2· 90% conf

The paper is generally transparent: methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. The only missing element is a reference to a reporting guideline (e.g., CONSORT).

Evidence

direct quote[Abstract, Support Statement]

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

direct quote[Discussion, paragraph 6]

direct quote[Support Statement and Disclosure forms]

“Funded by Coalition for Epidemic Preparedness Innovations (CEPI) and others. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 3· 90% conf

The manuscript is generally transparent: all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. However, methods completeness is slightly lacking (details in protocol) and no reporting guideline is referenced.

Evidence

direct quote[Methods, Trial design and oversight]

direct quote[Abstract]

“Trial reg: NCT04794218.”

direct quote[Discussion, final paragraph]

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

9 copyedit issues flagged: mostly clarity, consistency, punctuation.

Checked 38 references: 37 verified — 1 not checked.

Reproducibility

2 data/code links checked; 2 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper requires substantive revision before submission due to the absence of a data availability statement and missing ethical approval details (IRB name, informed consent). Additionally, statistical reporting and key resources documentation need improvement. The copyedit issues are minor and should be corrected. Addressing these gaps will substantially strengthen submission readiness.

1.
HIGHethics
Add a named IRB/ethics committee and protocol number in the Methods: e.g., 'The protocol was approved by the Institutional Review Board of [name] (protocol number [number]).'
Without a named approving body, the manuscript cannot confirm that ethical oversight was obtained.
2.
HIGHethics
Add a sentence stating that written informed consent was obtained from all participants.
Informed consent is a fundamental ethical requirement for human subjects research; its absence is a critical reporting gap.
3.
HIGHdata code
Add a Data Availability statement specifying how de-identified individual participant data can be accessed (e.g., via a managed-access platform or upon reasonable request to the corresponding author with a timeline).
Journal and funder policies increasingly require a data availability statement; its absence can lead to rejection.
4.
HIGHstatistics
Identify the statistical software used (e.g., SAS version 9.4, R version 4.x) in the Statistical Analysis section.
Software identification is essential for reproducibility; its omission was flagged by all three reviewers.
5.
HIGHreporting
Include a CONSORT flow diagram or reference the CONSORT checklist in the Methods.
A reporting guideline improves transparency and is expected for randomized clinical trials.
6.
HIGHstatistics
Report exact p-values for all analyses that used hypothesis tests (e.g., Spearman's rank correlations), or clearly state that no inferential testing was performed for primary outcomes.
Exact p-values (or a clear statement of descriptive-only analysis) are needed for transparency and reader interpretation.
7.
HIGHreporting
State the randomization method (e.g., computer-generated block randomization with stratification) in the main Methods, not only in the supplementary.
The randomization method is a core methodological detail that should be in the primary manuscript.
8.
HIGHreporting
List all inclusion and exclusion criteria in the main text, or explicitly state that full criteria are in a cited protocol.
Incomplete criteria reporting reduces reproducibility and was flagged by two reviewers.
9.
HIGHethics
Add a statement referencing the Declaration of Helsinki or ICH-GCP guidelines in the Methods.
Explicit regulatory framework citation strengthens the ethics statement and is standard for clinical trials.
10.
MEDIUMreporting
Provide a brief justification for the absence of a power analysis (e.g., 'As this is a Phase 1 safety and immunogenicity study, the sample size was based on feasibility and regulatory guidelines rather than a formal power calculation').
Acknowledging and justifying the absence of a power analysis preempts reviewer questions.
11.
MEDIUMreporting
Report race/ethnicity demographics in the main text (e.g., as part of Table 1) rather than only in the supplementary.
Key demographics in the main text improve generalizability assessment and reviewer confidence.
12.
MEDIUMcopyedit
Fix the empty parentheses in 'Results, Vaccine Safety and Reactogenicity' (appears as '...myalgia and chills (, ).') by inserting the correct figure reference or removing the parentheses.
Placeholder text suggests incomplete editing; a reader will notice this formatting error.
13.
LOWcopyedit
Standardize the Greek letter delta (Δ or ∆) throughout the manuscript to consistently use the same Unicode character for 'rVSVΔG-LASV-GPC'.
Minor consistency issue flagged by the copyedit pass; does not affect scientific understanding.
14.
LOWcopyedit
Rephrase the sentence about Group 4A assignment for clarity: 'Participants declining a second dose were assigned to Group 4A; additional participants were assigned to Group 4A to balance group sizes.'
The original sentence is ambiguous and could confuse readers.

Full text (37,672 chars)Analyzed: Jul 6, 2026

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Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

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Journal

DOI

10.1056/NEJMoa2501073

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