Rigor Reviewed

Rigor-Reviewed Manuscript

Low-Dose Yellow Fever Vaccine in Adults in Africa.

Name: Adcurare Rigor Record — Low-Dose Yellow Fever Vaccine in Adults in Africa.
Item: Low-Dose Yellow Fever Vaccine in Adults in Africa.
Rating: 79
Author: Adcurare

Kimathi D, Juan-Giner A, Bob NS, Orindi B, Namulwana ML, Diatta A, Cheruiyot S, Fall G, Dia M, Hamaluba MM, Nyehangane D, Karanja HK, Gitonga JN, Mugo D, Omuoyo DO, Hussein M, Oloo E, Kamau N, Wafula J, Bendera J, Silvester N, Mwavita J, Joshua M, Mwendwa J, Agababyona C, Ngetsa C, Aisha N, Moki F, Buluku T, Munene M, Mwanga-Amumpaire J, Lutwama J, Kayiwa J, Kamaara E, Barrett AD, Kaleebu P, Bejon P, Sall AA, Grais RF, Warimwe GM, NIFTY Investigators

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Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 3 high issues for “Low-Dose Yellow Fever Vaccine in Adults in Africa.”

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Adcurare Editorial

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

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability partially met−0.25★

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

Problems surfaced1 type

Data/code availability incomplete

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

This is a well-conducted, well-reported randomized noninferiority trial of fractional yellow fever vaccine doses. The major methodological gaps are a missing explicit informed consent statement, unidentified statistical software, a vague data-sharing statement, and minor copyedit issues. No validity-threatening statistical errors or retracted citations were found.

Evaluation covered all eight rigor dimensions using three independent reviewer ratings, a copyedit pass, a 17-reference citation check (none flagged), and recomputation of two reported tests (both consistent). The statistics check covered only tests with a reported test statistic + df, or effect + CI; threshold-only p-values were not re-evaluated. Dimensions not applicable to this human clinical trial were excluded from scoring.

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

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

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior research on yellow fever vaccine efficacy, fractional dosing, and the WHO recommendation, acknowledging limitations such as variability by manufacturer and batch. The rationale linking the need for dose-finding data to the study objectives is clear. Limitations of prior research (e.g., generalizability from Brazil, limited to young men) are explicitly addressed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise, citing prior work on yellow fever vaccine dose-finding and the need for dose-sparing strategies, and provides a logical rationale for the study.

Evidence

direct quote[Introduction, paragraphs 2-3]

“The World Health Organization (WHO) recommends the use of fractional doses of the vaccine as a dose-sparing strategy during outbreaks when there are vaccine shortages. This policy is supported by evidence from trials evaluating the immunogenicity and safety of one fifth of a standard dose... However, because the potency of doses can vary substantially according to manufacturer and batch, the generalizability of these data may be limited.”

direct quote[Introduction, paragraph 3]

“A dose-finding trial that was carried out in Brazil with the use of the 17DD vaccine substrain showed that a dose of 587 IU resulted in seroconversion in 96.9% of the participants... This trial involved young men with a mean age of 19.4 years, and hence further data are needed.”

direct quote[Introduction, paragraph 4]

“We conducted the Noninferiority Fractional-Doses Trial for Yellow Fever Vaccine (NIFTY) to assess the immunogenicity of fractional doses (1000 IU, 500 IU, or 250 IU) of the 17D-204 yellow fever vaccine manufactured by the Institut Pasteur de Dakar in Dakar, Senegal, for noninferiority to the standard vaccine dose (13,803 IU).”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior research on fractional dosing of yellow fever vaccine, acknowledging limitations of prior work, and providing a logical rationale for the dose-finding trial.

Evidence

direct quote[Introduction, paragraph 2]

“However, because the potency of doses can vary substantially according to manufacturer and batch, the generalizability of these data may be limited.”

direct quote[Introduction, paragraph 3]

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise, citing prior research on fractional dosing, vaccine shortages, and the need for dose-finding data, with a logical rationale for the study.

Evidence

direct quote[Introduction, paragraphs 2-3]

“However, because the potency of doses can vary substantially according to manufacturer and batch, the generalizability of these data may be limited.”

direct quote[Introduction, paragraph 4]

direct quote[Introduction, paragraph 3]

“This trial involved young men with a mean age of 19.4 years, and hence further data are needed.”

Randomization was performed using a computerized system with fixed blocks prepared by an independent firm. The trial was double-blind. A sample size calculation was provided (90% power, one-sided alpha 0.025, noninferiority margin -10 percentage points). Inclusion/exclusion criteria are clearly stated. The per-protocol analysis excluded participants with baseline yellow fever antibodies, which is justified. Outlier handling is not explicitly discussed, but the analysis populations are well-defined. Controls are appropriate (standard dose group). Independent replication is not reported, but this is a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous: a double-blind, randomized, noninferiority trial with a pre-specified sample size calculation, clear inclusion/exclusion criteria, and appropriate handling of missing data and exclusions.

Evidence

direct quote[Methods, Trial Design and Participants]

“Randomization was performed in fixed blocks prepared in advance by an independent firm (DiagnoSearch LifeSciences) with the use of a computerized randomization system, with equal allocation to each of the four dose groups.”

direct quote[Methods, Trial Design and Participants]

“This double-blind, randomized, noninferiority trial”

direct quote[Methods, Sample Size]

“Assuming a 95% incidence of seroconversion, we estimated that 120 participants per dose group would provide the trial with 90% power to determine noninferiority at a margin of −10 percentage points and at a one-sided alpha level of 0.025.”

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

direct quote[Methods, Trial Design and Participants]

“This double-blind, randomized, noninferiority trial was conducted...”

direct quote[Methods, Sample Size]

PASSReviewer 3· 95% conf

The study design is rigorous: double-blind, randomized, with adequate randomization method, sample size justification, and clear analysis populations.

Evidence

direct quote[Methods, Trial Design and Participants]

direct quote[Abstract]

“In this double-blind, randomized, noninferiority trial in Uganda and Kenya...”

direct quote[Methods, Sample Size]

The paper reports age (mean ± SD), sex (percentage female/male), and health status (including HIV status, CD4 count) in Table 1. Demographics are reported. Since both sexes are enrolled, sex_justified is not applicable. Species/strain/source and housing conditions are not applicable for a human clinical trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables are well-reported: sex, age, health status (including HIV status), and demographics are provided. Sex is reported for both sexes, so justification is not applicable. Species/strain/source and housing conditions are not applicable for a human trial.

Evidence

direct quote[Table 1]

“Age — yr | 40.2±11.0 | 38.5±11.7 | 40.4±11.6 | 39.8±11.9 | Sex — no. (%) | Female | 78 (65) | 68 (57) | 71 (59) | 79 (66) | Male | 42 (35) | 52 (43) | 49 (41) | 41 (34)”

direct quote[Table 1]

“HIV-positive — no. (%) | 8 (7) | 12 (10) | 5 (4) | 13 (11) | Median CD4+ cell count (IQR) — cells/μl | 653 (533−712) | 654 (428−884) | 943 (709−951) | 613 (480−758)”

WARNReviewer 2· 80% conf

Sex is reported, but weight is not reported and demographics do not include race/ethnicity.

Evidence

direct quote[Results, Participants]

“the majority of the participants (296 [62%]) were women”

absence[Table 1]

Weight is not reported.

direct quote[Table 1]

“Age — yr 40.2±11.0 ... HIV-positive — no. (%) 8 (7) ...”

PASSReviewer 3· 95% conf

The demographic and health characteristics of participants are comprehensively reported, including sex, age, and HIV status.

Evidence

direct quote[Table 1]

“Female — 78 (65%) [250 IU dose]; Mean age 40.2±11.0”

direct quote[Table 1 footnotes]

“Of the total number of participants who were positive for human immunodeficiency virus (HIV) infection, 35 had WHO clinical stage 1 disease, and 3 had WHO clinical stage 2 disease.”

direct quote[Results, Participants]

“The characteristics of the participants at baseline were similar across the trial groups”

The paper names four ethics committees that approved the protocol (Oxford Tropical Research Ethics Committee, KEMRI Scientific and Ethics Review Unit, Mbarara University Research Ethics Committee, Uganda National Council of Sciences and Technology). Regulatory approval from Kenya Pharmacy and Poisons Board and Uganda National Drug Authority is stated. Informed consent is not explicitly described in the main text, but the trial procedures (community meetings, screening) imply consent; however, a formal statement is missing. Regulatory compliance is stated through the named approvals.

Sub-criteria

iacuc statementN/A

informed consentINADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly reported: the trial was approved by named ethics committees and regulatory bodies, and informed consent is implied by the trial procedures. Regulatory compliance is stated.

Evidence

direct quote[Methods, Trial Oversight]

“The trial protocol was reviewed and approved by the Oxford Tropical Research Ethics Committee, the Kenya Medical Research Institute Scientific and Ethics Review Unit, Mbarara University of Science and Technology Research Ethics Committee, and the Uganda National Council of Sciences and Technology.”

direct quote[Methods, Trial Oversight]

“Regulatory approval was obtained from the Kenya Pharmacy and Poisons Board and the Uganda National Drug Authority.”

absence[Methods, Trial Design and Participants]

Informed consent is not explicitly described in the main text.

WARNReviewer 2· 85% conf

Ethics approval from named bodies is reported, but informed consent is not explicitly described and regulatory compliance does not name a specific framework.

Evidence

direct quote[Methods, Trial Oversight]

absence[Methods, Trial Design and Participants]

Informed consent is not described.

direct quote[Methods, Trial Oversight]

“Regulatory approval was obtained from the Kenya Pharmacy and Poisons Board and the Uganda National Drug Authority.”

PASSReviewer 3· 95% conf

Ethics approval by named committees and regulatory bodies, as well as compliance with relevant regulations, is clearly stated.

Evidence

direct quote[Methods, Trial Oversight]

“Regulatory approval was obtained from the Kenya Pharmacy and Poisons Board and the Uganda National Drug Authority.”

paraphrase[Methods, Trial Design and Participants]

“The paper describes community meetings to present the trial, and states that volunteers were able to adhere to trial procedures, but does not explicitly mention obtaining signed informed consent.”

The vaccine is identified as the Institut Pasteur de Dakar 17D-204 yellow fever vaccine, with dose levels specified. The PRNT assay is described as being conducted at a WHO-accredited reference laboratory. Statistical software is not explicitly named, but the analysis methods are described. For a clinical trial, the investigational product is the key resource, and it is adequately identified.

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

PASSReviewer 1· 95% conf

Key resources are adequately identified: the vaccine (manufacturer, dose levels), the PRNT assay (reference laboratory), and statistical software (implied but not named). The investigational product is clearly described.

Evidence

direct quote[Abstract]

“the Institut Pasteur de Dakar 17D-204 yellow fever vaccine at a standard dose (13,803 IU) or at a fractional dose of 1000 IU, 500 IU, or 250 IU”

direct quote[Methods, Laboratory Assessments]

“The plaque reduction neutralization test (PRNT) assays for this trial were conducted according to well-described standardized methods at the WHO-accredited regional yellow fever reference laboratory at the Institut Pasteur de Dakar.”

absence[Methods, Statistical Analysis]

Statistical software is not named.

WARNReviewer 2· 80% conf

The vaccine is adequately identified, but statistical software is not identified.

Evidence

direct quote[Abstract]

“vaccination with the Institut Pasteur de Dakar 17D-204 yellow fever vaccine at a standard dose (13,803 IU) or at a fractional dose of 1000 IU, 500 IU, or 250 IU”

absence[Methods, Statistical Analysis]

Statistical software is not identified.

PASSReviewer 3· 95% conf

The investigational vaccine and its source are clearly identified; other wet-lab resources are not applicable for this trial's scope.

Evidence

direct quote[Abstract and Methods]

“The Institut Pasteur de Dakar 17D-204 yellow fever vaccine at a standard dose (13,803 IU) or at a fractional dose of 1000 IU, 500 IU, or 250 IU.”

absence[Methods, Statistical Analysis]

No statistical software is named for the analysis.

The primary analysis uses a noninferiority approach with 95% confidence intervals for the difference in seroconversion incidence. Exact p-values are not reported, which is appropriate for a noninferiority trial. Effect sizes (differences) and confidence intervals are reported. Data presentation includes per-group n, incidence, and CIs. Assumptions are not explicitly verified, but the analysis uses standard methods. Statistical software is not identified. Mathematical plausibility is not applicable as the primary outcome is a proportion.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Statistical analysis is rigorous: tests are named (noninferiority analysis with confidence intervals), exact p-values are not reported (noninferiority is based on CIs), effect sizes and CIs are reported, data presentation includes per-group n and CIs, and mathematical plausibility is not applicable for continuous outcomes.

Evidence

direct quote[Methods, Statistical Analysis]

“Noninferiority was shown if the lower boundary of the 95% confidence interval of the difference in the incidence of seroconversion was greater than −10 percentage points.”

direct quote[Table 2]

“Difference vs. Standard Dose (95% CI) | −4.4 (−9.4 to 0.7) | 0.01 (−5.0 to 5.1) | 0.01 (−5.0 to 5.1) | Reference”

direct quote[Table 2]

“Participants with Seroconversion | no./total no. vaccinated | 108/115 | 115/117 | 115/117 | 114/116”

WARNReviewer 2· 80% conf

Effect sizes with confidence intervals are reported, but exact p-values are absent, assumptions are not verified, and statistical software is not named.

Evidence

direct quote[Results, Immunogenicity]

“The difference in the incidence of seroconversion between the 1000-IU dose and the standard dose was 0.01 percentage points (95% CI, −5.0 to 5.1)”

absence[Results, Immunogenicity]

No exact p-values are reported.

absence[Methods, Statistical Analysis]

Statistical software is not mentioned.

PASSReviewer 3· 95% conf

Statistical analyses are appropriate and well-reported, with named tests (noninferiority), exact p-values (or confidence intervals), and clear definitions of analysis populations.

Evidence

direct quote[Methods, Statistical Analysis]

“Noninferiority was shown if the lower boundary of the 95% confidence interval of the difference in the incidence of seroconversion was greater than −10 percentage points.”

direct quote[Table 2]

“Table 2: Difference vs. Standard Dose (95% CI) — Day 28: 250 IU: −4.4 (−9.4 to 0.7); 500 IU: 0.01 (−5.0 to 5.1)”

absence[Methods, Statistical Analysis]

Assumptions such as normality are not explicitly verified.

The paper states 'A data sharing statement provided by the authors is available with the full text of this article at NEJM.org', but the statement itself is not included in the main text. No repository deposit, accession numbers, or code sharing are reported. For a clinical trial, managed access is acceptable, but the statement is not concrete.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data sharing statement is mentioned but not provided in the main text; no repository deposit, accession numbers, or code sharing are reported. The statement is vague.

Evidence

direct quote[End of main text]

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org”

absence[Entire paper]

No repository deposit is reported.

absence[Entire paper]

No code sharing is reported.

PASSReviewer 2· 85% conf

A data sharing statement is referenced and trial registration is provided, which are adequate for a clinical trial without public data deposition.

Evidence

direct quote[Funding/Disclosures]

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.”

direct quote[Abstract]

“NIFTY ClinicalTrials.gov number, NCT04059471”

WARNReviewer 3· 80% conf

The paper states that a data sharing statement is available, but the actual statement is not provided in the main text and no repository or accession numbers are reported.

Evidence

direct quote[End of main text, before references]

“A data sharing statement provided by the authors is available with the full text of this article at NEJM.org”

absence[Full text]

No repository deposit is mentioned.

Methods are detailed enough for replication. The trial is registered at ClinicalTrials.gov (NCT04059471). Limitations are discussed (statistical power, generalizability to other substrains). Conclusions are proportional to the evidence. Funding sources and a COI statement are provided. A reporting guideline (e.g., CONSORT) is not explicitly referenced, but the trial is well-reported.

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· 95% conf

Reporting is transparent: methods are detailed, the trial is registered (NCT04059471), limitations are discussed, conclusions are proportional, and funding/COI are provided. A reporting guideline is not explicitly mentioned.

Evidence

direct quote[Abstract]

“NIFTY ClinicalTrials.gov number, NCT04059471”

direct quote[Discussion, paragraph 5]

“Our trial has limitations, including with regard to statistical power.”

direct quote[End of main text]

“Supported by grants from the European and Developing Countries Clinical Trials Partnership (EDCTP- RIA2016V-1633) and the Wellcome Trust (203077_Z_16_Z). Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 2· 90% conf

Methods are complete, trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. However, no reporting guideline is referenced.

Evidence

direct quote[Abstract]

“NIFTY ClinicalTrials.gov number, NCT04059471”

direct quote[Discussion]

“Our trial has limitations, including with regard to statistical power.”

direct quote[Funding/Disclosures]

“Supported by grants from the European and Developing Countries Clinical Trials Partnership (EDCTP- RIA2016V-1633) and the Wellcome Trust (203077_Z_16_Z).”

PASSReviewer 3· 95% conf

The trial is registered, methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are reported.

Evidence

direct quote[Abstract]

“NIFTY ClinicalTrials.gov number, NCT04059471”

direct quote[Discussion, paragraph 4]

“Our trial has limitations, including with regard to statistical power... we cannot exclude lower margins of noninferiority that may be relevant in some circumstances.”

direct quote[End of main text]

“Supported by grants from the European and Developing Countries Clinical Trials Partnership (EDCTP-RIA2016V-1633) and the Wellcome Trust (203077_Z_16_Z). Disclosure forms provided by the authors are available...”

9 copyedit issues flagged: mostly typo, other, clarity.

Checked 17 references: 15 verified — 2 not checked.

Reproducibility

2 data/code links checked; 1 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

Nearly ready for submission. The three warn-dimension gaps are standard pre-submission fixes: add an explicit informed consent statement, name the statistical software, and provide a concrete data sharing statement (including a repository plan). Fixing these plus the copyedit typos (6 minor terminology inconsistencies) will bring the paper to a clean pass on all dimensions.

1.
HIGHethics
Add an explicit statement in the Methods (Trial Design and Participants section) describing the informed consent process, specifying whether written or oral consent was obtained from all participants.
A missing informed consent statement is a standard requirement for human subjects research and will be flagged by any journal reviewer or editor.
2.
HIGHdata code
Replace the vague reference to 'a data sharing statement available at NEJM.org' with a concrete statement in the main text naming the repository (e.g., ClinicalTrials.gov, Vivli, Dryad) and providing the expected accession number or access mechanism.
Reviewers and journals now expect a specific data access route, not a placeholder reference to a journal website.
3.
HIGHreporting
Name the statistical software package and version used for all analyses (e.g., SAS, R, Stata) in the Methods, Statistical Analysis section.
Not naming the software is a reproducibility gap; journals typically require this information.
4.
MEDIUMethics
Add a statement of compliance with the Declaration of Helsinki (or ICH-GCP) in the Methods, Trial Oversight section.
While ethics committee approval is stated, an explicit reference to a recognized ethical framework strengthens the compliance statement.
5.
MEDIUMreporting
Reference the CONSORT reporting guideline in the Methods section, and consider appending a completed CONSORT checklist as supplementary material.
Although the paper follows CONSORT conventions, an explicit citation is standard practice and may be required by the target journal.
6.
MEDIUMreporting
Add a brief note in the Methods, Statistical Analysis section stating that statistical test assumptions (e.g., normality for continuous variables) were checked or justify why they were not relevant.
The absence of any mention of assumption verification is a transparency gap, even for a CI-based noninferiority analysis.
7.
MEDIUMdata code
If custom analysis code was used, deposit it in a public repository (e.g., GitHub, Zenodo) with a DOI and cite it in the manuscript.
Sharing analysis code is increasingly expected and supports reproducibility.
8.
LOWcopyedit
Correct the typo 'postran-domization' to 'post-randomization' in Methods, Statistical Analysis.
This is a clear typographical error that should be corrected for readability.
9.
LOWcopyedit
Correct inconsistent terminology: change 'fractionated dose' to 'fractional dose' throughout the Results (paragraph 1) and Discussion (paragraphs 1 and 4).
Consistent terminology improves clarity and avoids confusion.
10.
LOWcopyedit
Correct 'factional' to 'fractional' in Discussion, paragraph 1 and Results discussion of seroconversion differences.
Typo correction for professional presentation.
11.
LOWcopyedit
Add hyphen: change 'longterm efficacy' to 'long-term efficacy' in Discussion, paragraph 4.
Standard hyphenation for a compound adjective.
12.
LOWcopyedit
Clarify the relationship between 'vaccine-related adverse events' (abstract: 111 events) and 'probably related' events (Results: 70 events) to ensure consistency.
A reader may notice the apparent discrepancy; a brief explanation (e.g., '111 events were considered related, of which 70 were probably related') would resolve it.
13.
LOWcopyedit
Add a footnote reference for 'GMT' in the Table 2 header to ensure the abbreviation is defined.
Abbreviations in table headers should be defined in footnotes for standalone readability.

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DOI

10.1056/NEJMoa2407293

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