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Kaimen Rigor review

Adjuvanted inactivated rabies virus-vectored Lassa virus vaccine in healthy adults: a phase 1 trial.

Ortiz JR, Kurup D, Kaufman AC, Ben Hamed S, LaRocco AM, Lyke KE, Litts SM, Datta S, Liang Y, McGilvray MF, Losignor JA, Oshinsky JJ, Palmer KV, Johnson-Mayo IP, Scher G, Balakumar U, Chandwani A, Rapaka RR, Deming ME, Chua JV, Wirblich C, Chen WH, Neuzil KM, Pasetti MF, Schnell MJ

DOI: 10.1038/s41591-026-04429-z
Record issued: 2026-08-15
Engine: 7.39.0
Exported: 2026-09-20

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/8861bb5d-b89b-456a-b8b7-375436c9acef is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★

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

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The efficacy claim is based on immunogenicity endpoints (LASV-GPC IgG ELISA seroconversion and RABV neutralizing antibody titers) as surrogates for clinical protection against Lassa fever and rabies. While the paper cites a WHO correlate of protection for rabies (RFFIT ≥0.5 IU/ml), it does not provide a validated surrogate for Lassa fever protection; the LASV-GPC ELISA is not established as a correlate of clinical protection in humans. Target engagement at the tested dose is not demonstrated beyond immunogenicity.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary reported effect is 100% seroconversion for LASV-GPC ELISA and 100% seroprotection for rabies neutralizing antibodies. However, the clinical meaningfulness of these surrogate endpoints is not anchored to a minimal clinically important difference or a validated clinical outcome. The paper acknowledges no immune correlate of protection for Lassa fever, and the rabies correlate is for rabies, not Lassa. The effect size is presented as a positive result without demonstrating that the immune response translates to clinical benefit.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 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 clinical trial is methodologically rigorous with clear randomization, blinding, and detailed reporting of demographics and ethics. The main weakness is the vague data availability statement, which lacks a specific repository or accession number, and minor reporting gaps such as not explicitly citing a reporting guideline and occasional threshold-only p-values.

Both reviewers classified the study as interventional and agreed on all dimension statuses. The only divergence was in key resources (software identification) and statistical analysis (exact p-values), resolved by adopting the more specific evidence from Reviewer 2. The statistics verification recomputed only 2 tests; the rest are unverified. 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

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p < .050 · recomputed p = <.001Reviewer 1
Fisher's exact test for moderate warmth after dose 2 in group C vs others
“Moderate 0 (0.0) | 1 (6.7) | 10 (71.4)* | 2 (22.2) | 11 (25.0)”
Find in source
Taken as given: The table is 2x2 comparing group C (10 events, 4 non-events) vs all others (1 event, 29 non-events).; The reported p-value is from Fisher's exact test.
Method: Fisher's exact test on 2x2 table from group C vs others.
How we recomputed it: pFisher2x2(10,4,1,29,0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Spearman correlation between ELISA and RFFIT titers
“ELISA and RFFIT titers were strongly associated (Spearman’s ρ = 0.89; 95% CI 0.86–0.91; P < 0.001; n = 268)”
Find in source
Taken as given: The reported Spearman rho is 0.89.; The sample size n is 268.; The p-value is two-tailed.
Method: Computed two-tailed p-value for Spearman correlation using the t-distribution approximation: t = r * sqrt((n-2)/(1-r^2)), then p = 2 * (1 - tCdf(t, n-2)).
How we recomputed it: pR(0.89, 268)

lowinternal contradiction
The abstract states '100.0% (44 of 44) of LASSARAB recipients' seroconverted, but the results section reports day 61 seroconversion of 100% for all LASSARAB groups, which is consistent. However, the abstract also states '0.0% (0 of 10) of controls' seroconverted, but the results section reports day 61 seroconversion of 0% for controls, which is consistent. No contradiction found.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
AbstractFind in source

Overstated conclusions

2 findings · worst high

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.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed

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

supportedReviewers 1, 2
LASSARAB + aPHAD-SE demonstrated a favorable safety profile.
The safety data presented support this claim, with no serious AEs and mostly mild events.
Evidence: Table 4 shows no serious AEs, and reactogenicity was predominantly mild.
“LASSARAB + 3D-6-acyl phosphorylated hexaacyl disaccharide (PHAD)-SE demonstrated a favorable safety profile and immunogenicity against Lassa and rabies viruses.”
AbstractFind in source
supportedReviewer 1
LASSARAB induced 100% seroconversion against Lassa and rabies after two doses.
The data show 100% seroconversion for LASV-GPC and RABV in all LASSARAB groups at day 61.
Evidence: Results section: 'After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients' and 'Rabies glycoprotein IgG ELISA seroconversion ... were also 100% across all groups'.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
AbstractFind in source
supportedReviewer 1
The vaccine elicited RABV-neutralizing antibodies meeting the WHO correlate of protection.
Seroprotection rates reached 100% in all groups by day 36, supporting the claim.
Evidence: Results: 'From day 36 through day 61, seroprotection was 100% across all groups.'
Two intramuscular doses induced rapid and near-universal LASV-GPC seroconversion and achieved high RABV-neutralizing antibody titers that met the established WHO correlate of protection.
Discussionreviewer’s wording
supportedReviewers 1, 2
The vaccine is well tolerated and elicits robust dual humoral immunity.
The safety and immunogenicity data support this conclusion.
Evidence: Overall safety profile and immunogenicity results.
“LASSARAB + aPHAD-SE, an adjuvanted inactivated rabies-vectored LASV-GPC vaccine, is well tolerated and elicits robust dual humoral immunity to Lassa and rabies viruses.”
DiscussionFind in source
supportedReviewer 2
LASSARAB induced immunogenicity to both Lassa and rabies viruses.
The immunogenicity data show 100% seroconversion for LASV-GPC and RABV in LASSARAB groups, supporting the claim.
Evidence: Results show 100% seroconversion for LASV-GPC and RABV ELISA in LASSARAB groups by day 61.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
AbstractFind in source
supportedReviewer 2
The vaccine induced rabies seroprotection at levels meeting the WHO correlate of protection.
The RFFIT data show 100% seroprotection in all groups by day 36, supporting the claim.
Evidence: Results show 100% seroprotection (≥0.5 IU/ml) across all groups from day 36 onward.
“Rabies glycoprotein IgG ELISA seroconversion (≥fourfold rise) and neutralizing antibody by rapid fluorescent focus inhibition test (RFFIT) seroprotection (≥0.5 IU ml −1 ) were also 100% across all groups, including controls.”
AbstractFind in source
supportedReviewer 2
The safety profile was comparable to that of a licensed rabies vaccine.
The reactogenicity data show similar rates between LASSARAB groups and control, supporting the claim.
Evidence: Table 2 and 3 show similar solicited event rates between groups.
“Notably, the safety profile was comparable to that of a licensed rabies vaccine.”
DiscussionFind in source

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

INADEQUATESurrogate endpoint
The efficacy claim is based on immunogenicity endpoints (LASV-GPC IgG ELISA seroconversion and RABV neutralizing antibody titers) as surrogates for clinical protection against Lassa fever and rabies. While the paper cites a WHO correlate of protection for rabies (RFFIT ≥0.5 IU/ml), it does not provide a validated surrogate for Lassa fever protection; the LASV-GPC ELISA is not established as a correlate of clinical protection in humans. Target engagement at the tested dose is not demonstrated beyond immunogenicity.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
Find in source
INADEQUATEEffect size
The primary reported effect is 100% seroconversion for LASV-GPC ELISA and 100% seroprotection for rabies neutralizing antibodies. However, the clinical meaningfulness of these surrogate endpoints is not anchored to a minimal clinically important difference or a validated clinical outcome. The paper acknowledges no immune correlate of protection for Lassa fever, and the rabies correlate is for rabies, not Lassa. The effect size is presented as a positive result without demonstrating that the immune response translates to clinical benefit.
“After two doses, Lassa virus GPC IgG ELISA seroconversion (≥fourfold rise) was achieved in 100.0% (44 of 44) of LASSARAB recipients and 0.0% (0 of 10) of controls.”
Find in source

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

1 finding · 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

Eight Dimensions7 pass · 1 warn

The introduction thoroughly reviews the epidemiology of Lassa fever, the lack of licensed vaccines, and the immune mechanisms of protection, citing numerous references. It also describes the development of LASSARAB and its preclinical efficacy in animal models, providing a logical rationale for the trial. Limitations of prior research are implicitly addressed by noting the absence of immune correlates and the need for clinical evaluation.

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 strong scientific premise by citing prior research on Lassa fever burden, vaccine development challenges, and preclinical data supporting LASSARAB.

Evidence

“Lassa fever causes substantial morbidity and mortality in West Africa, and no licensed vaccine is available.”

Introduction ¶1Find in source

paraphrase[Introduction, last paragraph]

“Adjuvanted LASSARAB demonstrated protective efficacy in preclinical studies, preventing lethal LASV challenge in animal models.”

“Complicating LASV vaccine development is that the immune mechanisms of protection are not fully understood.”

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The paper establishes a strong scientific premise with extensive prior work and a clear rationale for the vaccine.

Evidence

paraphrase[Introduction, paragraph 1-3]

“Adjuvanted LASSARAB demonstrated protective efficacy in preclinical studies, preventing lethal LASV challenge in animal models.”

“This platform incorporates the rabies virus (RABV) glycoprotein, which could simultaneously confer immunity to rabies and thereby enhance the feasibility and public health value of a combination vaccine in endemic regions.”

Introduction ¶3Find in source

“Complicating LASV vaccine development is that the immune mechanisms of protection are not fully understood.”

Introduction ¶2Find in source

Randomization method (block randomization) and unit (participant) are reported. Blinding is described: participants and assessors blinded to group assignment, with unblinded vaccinators. Inclusion/exclusion criteria are detailed. Power analysis is not applicable as the study explicitly states no formal power calculations. Outlier handling is addressed through sensitivity analysis excluding a participant with high baseline titers. Controls are appropriate (licensed rabies vaccine). Independent replication is not applicable for a single phase 1 trial.

Sub-criteria

controlsADEQUATE

power analysisN/A

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· 85% conf

The trial design is rigorous with randomization, blinding, and a clear dose-escalation protocol, though power analysis is not applicable for this phase 1 study.

Evidence

“Eligible participants were enrolled and randomized to study groups using block randomization generated by the study statistician.”

MethodsFind in source

“Participants and all other study personnel were blinded to treatment allocation until study completion and database lock.”

MethodsFind in source

“There were no prespecified hypotheses or formal power calculations.”

AbstractFind in source

PASSReviewer 2· 85% conf

The trial design is rigorous with randomization, blinding, and clear inclusion/exclusion criteria, though power analysis is not applicable for a phase 1 trial.

Evidence

“Eligible participants were enrolled and randomized to study groups using block randomization generated by the study statistician.”

Methods ¶3Find in source

“Unblinded staff were responsible for vaccine accountability, storage, preparation and administration, but were not involved in subsequent safety or immunogenicity assessments.”

Methods ¶2Find in source

“We enrolled healthy, nonpregnant, nonlactating adults aged 18–50 years.”

Methods ¶1Find in source

Sex is reported for all participants, and both sexes are enrolled, so sex_justified is not applicable. Age, BMI, and health status are reported. Demographics include age, sex, ethnicity, and race. Species/strain and housing conditions 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

Demographic and baseline characteristics are well reported, including sex, age, BMI, ethnicity, and race.

Evidence

paraphrase[Table 1]

“Female 8 (53.3) | 6 (40.0) | 5 (35.7) | 5 (50.0) | 24 (44.4)”

paraphrase[Table 1]

“Age, years (mean ± s.d.) 34.0 ± 8.9 | 32.3 ± 6.5 | 31.6 ± 7.3 | 31.8 ± 6.4 | 32.5 ± 7.3”

paraphrase[Table 1]

“Hispanic 2 (13.3) | 2 (13.3) | 0 (0.0) | 2 (20.0) | 6 (11.1)”

PASSReviewer 2· 90% conf

Demographic and baseline characteristics are well reported, including sex, age, BMI, and race/ethnicity.

Evidence

“Female | 8 (53.3) | 6 (40.0) | 5 (35.7) | 5 (50.0) | 24 (44.4)”

Table 1Find in source

“Age, years (mean ± s.d.) | 34.0 ± 8.9 | 32.3 ± 6.5 | 31.6 ± 7.3 | 31.8 ± 6.4 | 32.5 ± 7.3”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity, n (%) | Hispanic | 2 (13.3) | 2 (13.3) | 0 (0.0) | 2 (20.0) | 6 (11.1)”

The protocol and informed consent forms were approved by the University of Maryland Baltimore Institutional Review Board (IRB) with protocol number HP-00110576. Informed consent is implied as the IRB approved the consent forms. Regulatory compliance is stated through adherence to FDA and IRB feedback and trial registration.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study has clear ethics approval from a named IRB and describes informed consent, with regulatory compliance.

Evidence

“The protocol and informed consent forms were approved by the UMB, Institutional Review Board (IRB) (HP-00110576).”

MethodsFind in source

paraphrase[Methods, Regulatory and ethics]

“The trial was registered at ClinicalTrials.gov (NCT06546709) on 4 December 2024.”

PASSReviewer 2· 95% conf

Ethical approvals and consent are clearly documented with a named IRB and protocol number.

Evidence

“The protocol and informed consent forms were approved by the UMB, Institutional Review Board (IRB) (HP-00110576).”

EthicsFind in source

“The protocol and informed consent forms were approved by the UMB, Institutional Review Board (IRB) (HP-00110576).”

EthicsFind in source

“Version 1 was submitted to the US FDA but was not submitted to the IRB.”

EthicsFind in source

The investigational product LASSARAB is described with antigen content and adjuvant, and the control Imovax Rabies is identified with manufacturer. Reagents for assays are mentioned but not fully cataloged. Software for statistical analysis is not identified, which is a minor gap.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational vaccine and control are identified with manufacturer and formulation details; software used for analysis is not specified.

Evidence

“Group D, the control group, received the licensed inactivated rabies vaccine (Imovax Rabies; Sanofi Pasteur) in its commercial presentation.”

MethodsFind in source

absence[Methods, Statistical analysis]

Statistical software not identified.

PASSReviewer 2· 85% conf

The investigational product and control vaccine are well identified, and statistical software is named.

Evidence

“LASSARAB + aPHAD-SE was administered in three dose groups: group A received 700 rU of antigen with 5 µg of adjuvant in 1 ml; group B received 1,400 rU of antigen with 5 µg of adjuvant in 1 ml; and group C received two concurrent injections of the medium-dose preparation for a total of 2,800 rU of antigen and 10 µg of adjuvant.”

Methods ¶1Find in source

“Group D, the control group, received the licensed inactivated rabies vaccine (Imovax Rabies; Sanofi Pasteur) in its commercial presentation.”

Methods ¶1Find in source

paraphrase[Methods, Statistical analysis section]

“Statistical analyses were performed using R version 4.3.1.”

Tests such as Fisher's exact test, Wilcoxon signed-rank, and Kruskal-Wallis are named. Effect sizes are reported as GMTs with 95% CIs. Exact p-values are not reported (only P < 0.05), which is acceptable for this exploratory analysis. Software is not identified. Data presentation includes individual data points in figures and per-group n. Mathematical plausibility checks are not applicable due to continuous outcomes and small N.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Statistical tests are named, effect sizes with CIs are reported, and data presentation is appropriate for a clinical trial, though exact p-values are not always given.

Evidence

paraphrase[Methods, Statistical analysis]

“Fisher’s exact test, Wilcoxon signed-rank test, Kruskal–Wallis test”

paraphrase[Results, Secondary objective]

“GMTs increased significantly from baseline in the LASSARAB-containing study groups: 8.8 IU ml−1 (95% CI 3.3–23.6) for group A”

paraphrase[Table 3 footnote]

“Fisher’s exact test (P < 0.05)”

PASSReviewer 2· 80% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

paraphrase[Methods, Statistical analysis section]

“Within-group comparisons to baseline used Wilcoxon signed-rank tests; between-group comparisons used Kruskal-Wallis tests; Fisher's exact test was used for categorical comparisons.”

“ELISA and RFFIT titers were strongly associated (Spearman’s ρ = 0.89; 95% CI 0.86–0.91; P < 0.001; n = 268)”

ResultsFind in source

“By day 29, GMTs increased significantly from baseline in the LASSARAB-containing study groups: 8.8 IU ml −1 (95% CI 3.3–23.6) for group A”

ResultsFind in source

The data availability statement says individual-level data will be deposited in a public repository within 1 year of database lock, but no repository or accession number is given. This is a concrete plan but not yet fulfilled. Repository deposit and accession numbers are not applicable for interim data. Code sharing is not applicable as no custom code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, with no immediate repository deposit or accession numbers; code sharing is not applicable.

Evidence

“Anonymized individual-level data and a complete data dictionary will be deposited in a publicly accessible repository within 1 year of database lock and completion of the final study analysis (anticipated June 2027).”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Data availability statement is present but vague, with no immediate repository deposit or accession numbers.

Evidence

“Study data are maintained in controlled-access storage at the Univ. of Maryland School of Medicine. Individual-level participant data are not currently available because this report represents an interim analysis and the study remains blinded; unblinded data will not be accessible until completion of all study visits, database lock and final study analysis.”

Data availabilityFind in source

Trial registration number is provided. Methods are detailed enough for replication. Limitations are explicitly discussed. Conclusions are appropriately cautious for a phase 1 interim analysis. Funding and COI statements are present. Reporting guideline is not explicitly mentioned but the paper follows CONSORT-like structure.

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 is transparent with trial registration, detailed methods, limitations, and proportional conclusions.

Evidence

“ClinicalTrials.gov identifier NCT06546709”

AbstractFind in source

“As a phase 1 trial, there were no prespecified hypotheses, the sample size was not powered to detect between-group differences, and any post hoc analyses should be interpreted with caution.”

LimitationsFind in source

“This project has been funded in whole or in part with federal funds from the NIAID, National Institutes of Health and Department of Health and Human Services, under contract no. HHSN272201700082C”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, detailed methods, and discussion of limitations.

Evidence

paraphrase[Regulatory and ethics section]

“The trial was registered at ClinicalTrials.gov ( NCT06546709 ) on 4 December 2024.”

“Our study has several limitations. As a phase 1 trial, there were no prespecified hypotheses, the sample size was not powered to detect between-group differences, and any post hoc analyses should be interpreted with caution.”

Discussion ¶7Find in source

AcknowledgementsFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

ClinicalTrials.gov

NCT06546709

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 57 references by DOI: 46 verified — 11 no DOI (shown, not verified).

NO DOI
Lassa fever
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Lassa fever suspected in death of US traveler returning from West Africa
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
WHO expert consultation on rabies: third report
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
ERVEBO (Ebola Zaire Vaccine, Live)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Global market study: measles-containing vaccines (MCV) – Public Summary
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Human rabies prevention-United States, 2008: recommendations of the Advisory Committee on Immunization Practices
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Human Rabies Vaccines Global Market Study – Public Summary
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Imovax rabies
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
A rapid reproducible test for determining rabies neutralizing antibody
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Laboratory Techniques in Rabies
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Good review practice: clinical review of investigational new drug applications
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

1 data/code link checked; 1 live.

datahttps://www.clinicaltrials.gov/study/NCT06546709LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

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 clarity, consistency, grammar.

MINORconsistencyAbstract
“3D-6-acyl PHAD-SE”
→ Define abbreviation at first use in abstract.
Abbreviation used without definition in abstract.
MINORclarityMethods, Statistical analysis
“Statistical analyses were performed using R (version 4.3.1).”
→ Specify software version if used.
Software not identified in the paper.
MINORclarityResults, Post hoc analysis
“we found no differences between study groups for dose 1 and found differences between study groups for dose 2 for warmth, itching, tenderness and pain ( P < 0.05).”
→ Clarify which groups differed.
The sentence is ambiguous about which groups showed differences.
MINORgrammarDiscussion, paragraph 5
“The RABV platform provides a well-established foundation for a dual-target vaccine .”
→ Remove extra space before period.
Extra space before period.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported; an informed reader should weigh the minor gaps in data availability specificity and the lack of an explicit reporting guideline. No erratum is warranted, but the authors should consider providing a concrete data repository plan and clarifying the post hoc group differences.

1.
HIGHdata code
In the Data availability section, specify the intended repository (e.g., Dryad, Zenodo) and provide a provisional accession number or DOI to make the statement concrete.
The current statement is vague and does not meet common data-sharing expectations, which could be a reviewer concern.
2.
HIGHreporting
In the Methods, add a statement referencing the CONSORT reporting guideline to enhance transparency.
Explicitly citing the reporting guideline improves transparency and is a common reviewer request.
3.
MEDIUMstatistics
In the Results, report exact p-values (e.g., P=0.03) instead of thresholds (P<0.05) where feasible, to improve transparency.
Threshold-only p-values are less informative and can be seen as imprecise reporting.
4.
MEDIUMother
In the Methods, provide more details on the ELISA and RFFIT assay reagents (e.g., vendor, catalog numbers) to meet key resource identification standards.
Full reagent identification enhances reproducibility.
5.
MEDIUMreporting
In the Results, clarify which study groups differed for dose 2 local reactions (warmth, itching, tenderness, pain) as the current sentence is ambiguous.
Ambiguity in reporting group differences could confuse readers and reviewers.
6.
MEDIUMdata code
In the Data availability section, clarify whether any custom analysis code will be shared and if so, where.
Clarifying code sharing enhances reproducibility.
7.
MEDIUMreporting
In the Discussion, add a sentence on the generalizability of the findings to endemic populations, acknowledging the limitation of the healthy adult cohort.
Addressing generalizability strengthens the discussion.
8.
MEDIUMother
In the Methods, provide more detail on the randomization sequence generation and allocation concealment to fully meet CONSORT requirements.
Detailed randomization procedures improve transparency and reproducibility.
9.
LOWcopyedit
In the Abstract, define the abbreviation '3D-6-acyl PHAD-SE' at first use.
Abbreviations should be defined at first use for clarity.
10.
LOWcopyedit
In the Discussion, remove the extra space before the period in the sentence about the RABV platform.
Minor typographical error that should be corrected.

Full text (97,341 chars · analyzed ~77%, head + tail)Analyzed: Aug 15, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Adjuvanted inactivated rabies virus-vectored Lassa virus vaccine in healthy adults: a phase 1 trial.

DOI

10.1038/s41591-026-04429-z

Record issued

2026-08-15

Engine

7.39.0

Exported

2026-09-20