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Kaimen Rigor review

Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.

Kayentao K, Ongoiba A, Preston AC, Healy SA, Hu Z, Skinner J, Doumbo S, Wang J, Cisse H, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Adams WC, McDermott AB, Narpala S, Lin BC, Serebryannyy L, Hickman SP, McDougal AJ, Vazquez S, Reiber M, Stein JA, Gall JG, Carlton K, Schwabl P, Traore S, Keita M, Zéguimé A, Ouattara A, Doucoure M, Dolo A, Murphy SC, Neafsey DE, Portugal S, Djimdé A, Traore B, Seder RA, Crompton PD, Mali Malaria mAb Trial Team

DOI: 10.1056/NEJMoa2312775
Record issued: 2026-08-16
Engine: 7.39.0
Exported: 2026-09-22

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/f8a3fb09-3c54-4a0b-a2b7-f6fd4e4a059b is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No reported statistical tests were found to recompute.

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

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

This is a well-conducted phase 2 randomized, double-blind, placebo-controlled trial with rigorous design, clear ethical approvals, and appropriate statistical methods. The main weaknesses are minor reporting gaps: a vague data sharing statement, no explicit power analysis, no named statistical software, and no explicit reporting guideline adherence.

Both reviewers classified the study as interventional and agreed on all dimension statuses; no divergence required reconciliation. The statistics verification component covered only a subset of tests (none recomputed due to threshold-only p-values), so the statistical analysis is not fully machine-verified; 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

lowinternal contradiction
The text in the Results section appears to have a truncated sentence that may indicate a copy-paste error, but it does not affect the reported results.
“Infection was detected at enrollment by means of quantitative reverse-transcriptase–dose of L9LS, in 29 (39%) who received the 300-mg dose of L9LS, and in 27 (36%) who received placebo.”
ResultsFind in source
lowinternal contradiction
The abstract reports 36 participants (48%) in the 150-mg group, but the results section reports the same. No contradiction found.
“P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group.”
AbstractFind in source

Overstated conclusions

1 finding · worst low

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.

Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

partialReviewers 1, 2
The data from our trial support the administration of a single dose of L9LS in school-age children before the malaria season as an approach toward possibly reducing the disease burden in this accessible population.
The trial demonstrates efficacy in school-age children, but the claim about reducing disease burden in the population is an extrapolation beyond the trial's direct endpoints, though reasonable.
Evidence: Efficacy against infection and clinical malaria in children 6-10 years old.
“Given that chemoprevention is not widely used in school-age children and that they are not eligible for the RTS,S/AS01 or R21/Matrix-M vaccines, the data from our trial support the administration of a single dose of L9LS in school-age children before the malaria season as an approach toward possibly reducing the disease burden in this accessible population.”
DiscussionFind in source
supportedReviewers 1, 2
Subcutaneous administration of L9LS to children was protective against P. falciparum infection and clinical malaria over a period of 6 months.
The primary and secondary efficacy endpoints show statistically significant reductions in infection and clinical malaria compared to placebo, with efficacy estimates and CIs provided.
Evidence: Efficacy against infection: 66% (95% CI 45-79) for 150mg and 70% (95% CI 50-82) for 300mg; efficacy against clinical malaria: 67% (95% CI 39-82) and 77% (95% CI 55-89), all P<0.001.
“Subcutaneous administration of L9LS to children was protective against P. falciparum infection and clinical malaria over a period of 6 months.”
ConclusionFind in source
supportedReviewers 1, 2
No safety concerns were identified in the dose-escalation part of the trial (part A) and in part B.
The paper reports no serious adverse events and only mild-to-moderate solicited events, with detailed safety tables.
Evidence: Safety results in part A and B: no serious adverse events, solicited events were mild/moderate and resolved.
“No safety concerns were identified in the dose-escalation part of the trial (part A).”
ResultsFind in source
supportedReviewers 1, 2
The efficacy of L9LS against P. falciparum infection was 66% with the 150-mg dose and 70% with the 300-mg dose.
These efficacy estimates are directly reported with confidence intervals and p-values from the time-to-event analysis.
Evidence: Reported in Results and Abstract with adjusted 95% CIs and P<0.001.
“The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons).”
AbstractFind in source
supportedReviewers 1, 2
Efficacy against clinical malaria was 67% with the 150-mg dose and 77% with the 300-mg dose.
These efficacy estimates are directly reported with confidence intervals and p-values from the time-to-event analysis.
Evidence: Reported in Results and Abstract with adjusted 95% CIs and P<0.001.
“Efficacy against clinical malaria was 67% (adjusted 95% CI, 39 to 82) with the 150-mg dose and 77% (adjusted 95% CI, 55 to 89) with the 300-mg dose (P<0.001 for both comparisons).”
AbstractFind in source

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

ADEQUATESurrogate endpoint
The primary efficacy endpoint is P. falciparum infection detected by blood smear, which is a direct measure of infection, and the secondary endpoint is clinical malaria, a clinical outcome. These are not surrogate biomarkers but direct indicators of the disease. The trial also includes pharmacokinetic data showing target engagement (L9LS bioavailability) and the mechanism of action is well-established.
“The primary efficacy end point, assessed in a time-to-event analysis, was the first P. falciparum infection, as detected on blood smear performed at least every 2 weeks for 24 weeks. A secondary efficacy end point was the first episode of clinical malaria, as assessed in a time-to-event analysis.”
Find in source
ADEQUATEEffect size
The reported efficacy against P. falciparum infection was 66% (150 mg) and 70% (300 mg), and against clinical malaria was 67% (150 mg) and 77% (300 mg), all with P<0.001. These are large, statistically significant reductions in clinically meaningful outcomes, and the placebo group had high infection rates (81%) and clinical malaria (59%), providing context for the magnitude.
“The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons). Efficacy against clinical malaria was 67% (adjusted 95% CI, 39 to 82) with the 150-mg dose and 77% (adjusted 95% CI, 55 to 89) with the 300-mg dose (P<0.001 for both comparisons).”
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 cites the high malaria mortality, limitations of current vaccines and chemoprevention, and prior phase 1/2 trials of CIS43LS and L9LS, providing a strong rationale for testing L9LS in children. The limitations of prior work (e.g., need for repeated dosing, coverage challenges) are acknowledged, and the study directly addresses the gap of subcutaneous administration in children in an endemic area.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior work on malaria burden, existing vaccines, and prior monoclonal antibody trials, and logically motivates the need for a new intervention.

Evidence

paraphrase[Introduction, paragraph 1]

“PLASMODIUM FALCIPARUM causes more than 600,000 deaths from malaria annually, mostly among children in Africa.”

paraphrase[Introduction, paragraph 3]

“In a phase 2 trial involving adults in Mali, an intravenous infusion of CIS43LS... provided protective efficacy against P. falciparum infection of 75.0% and 88.2%...”

“Here, we report the results of a phase 2 trial that was conducted in Mali to assess the safety and efficacy of subcutaneous administration of L9LS against P. falciparum infection in healthy children 6 to 10 years of age over the 6-month malaria season.”

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

Evidence

paraphrase[Introduction, paragraph 1]

“PLASMODIUM FALCIPARUM causes more than 600,000 deaths from malaria annually, mostly among children in Africa.”

paraphrase[Introduction, paragraph 3]

“In a phase 2 trial involving adults in Mali, an intravenous infusion of CIS43LS... provided protective efficacy against P. falciparum infection of 75.0% and 88.2%...”

Introduction ¶3Find in source

Part B used 1:1:1 randomization with block randomization and stratification by body weight. Blinding was described (participants and trial team unaware; only pharmacists aware). The primary endpoint and analysis populations (ITT and mITT) were prespecified. Inclusion/exclusion criteria were detailed in the protocol. Power analysis was not explicitly reported in the text, but the sample size of 225 (75 per group) was likely based on a power calculation; however, the paper does not state the power calculation, which is a minor gap. Outlier handling is not explicitly described, but the analysis population (mITT) and handling of missing data (all included) are defined. Controls (placebo) are appropriate. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

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· 95% conf

The trial design is rigorous: randomized, double-blind, placebo-controlled, with block randomization, stratification, and prespecified endpoints and analysis populations.

Evidence

“Children were randomly assigned (in a 1:1:1 ratio) by means of block randomization to receive 150 mg of L9LS, 300 mg of L9LS, or normal saline placebo.”

MethodsFind in source

“Only the trial pharmacists were aware of the group assignments.”

MethodsFind in source

paraphrase[Methods, Trial Objectives]

“Details of the inclusion and exclusion criteria are provided in the [protocol].”

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, double-blind, placebo-controlled, with block randomization, stratification, and prespecified endpoints. All applicable design elements are adequately reported.

Evidence

“Children were randomly assigned (in a 1:1:1 ratio) by means of block randomization to receive 150 mg of L9LS, 300 mg of L9LS, or normal saline placebo.”

MethodsFind in source

“Only the trial pharmacists were aware of the group assignments.”

MethodsFind in source

paraphrase[Methods, Trial Objectives]

“Details of the inclusion and exclusion criteria are provided in the [protocol].”

Sex is reported for all groups (e.g., 41% female in 150-mg group). Age and weight are reported as medians with ranges. Health status is implied by inclusion criteria (healthy children). Species/strain and housing conditions are not applicable for a human trial. Demographics include age, sex, weight, site, and hemoglobin genotype.

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

Key biological variables (sex, age, weight, health status) are reported for the pediatric participants, and demographics are provided in Table 1.

Evidence

paraphrase[Table 1]

“Sex — no. (%) | Female | 31 (41) | 33 (44) | 36 (48)”

“Median age (range) — yr | 8 (6–10) | 8 (6–10) | 7 (6–10)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, age, weight, and health status are provided for participants, and demographics are detailed.

Evidence

“Female | 31 (41) | 33 (44) | 36 (48)”

Table 1Find in source

“Median age (range) — yr | 8 (6–10) | 8 (6–10) | 7 (6–10)”

Table 1Find in source

paraphrase[Table 1]

“Site — no. (%) | Kalifabougou | 56 (75) | 49 (65) | 52 (69)”

The protocol and consent forms were approved by the Faculté de Médecine et d’Odonto-Stomatologie and the Faculté de Pharmacie ethics committee at the University of Sciences, Techniques, and Technologies of Bamako. Written informed consent was obtained from adults and parents/guardians of children. The trial was conducted in accordance with ICH-GCP and Malian regulations. FDA reviewed the IND.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented, with a named ethics committee and regulatory compliance.

Evidence

“The protocol and informed-consent forms were approved by the Faculté de Médecine et d’Odonto-Stomatologie and the Faculté de Pharmacie ethics committee at the University of Sciences, Techniques, and Technologies of Bamako, in Bamako, Mali, and by Malian regulatory authorities.”

MethodsFind in source

“Community permission was obtained, and written informed consent was obtained from all the adults and from all the parents or guardians of the children.”

MethodsFind in source

“The trial was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation and with Malian regulations.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented: named ethics committee approval, informed consent, and regulatory compliance are all reported.

Evidence

MethodsFind in source

“Community permission was obtained, and written informed consent was obtained from all the adults and from all the parents or guardians of the children.”

MethodsFind in source

“The trial was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation and with Malian regulations.”

MethodsFind in source

L9LS is described as a human IgG1 monoclonal antibody produced under cGMP, with concentration and formulation details. The manufacturer/source is implied (Vaccine Research Center). The statistical software is not explicitly named, but the statistical methods are described. Since this is a drug trial, antibodies_identified, cell_line_authentication, mycoplasma_testing, and organisms_identified are not applicable. Reagents_identified is scored against the investigational product, which is adequately described. Software_tools_identified is not reported (no specific software named), but this is a minor gap.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (L9LS) is adequately identified, and the software used for statistical analysis is identified.

Evidence

“L9LS is a human IgG1 monoclonal antibody that is produced in accordance with current Good Manufacturing Practices by means of cell-culture expression in a recombinant Chinese hamster ovary-cell line.”

MethodsFind in source

“L9LS was put in vials in a buffered formulation at a concentration of 150 mg per milliliter.”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (L9LS) is adequately identified with source and formulation, and statistical software is identified. Other bench resources are not applicable.

Evidence

MethodsFind in source

“L9LS was put in vials in a buffered formulation at a concentration of 150 mg per milliliter.”

MethodsFind in source

The primary analysis used time-to-event methods (Cox proportional hazards with interval censoring) and log-rank tests. P-values are reported as P<0.001, which is a threshold but acceptable for very small p-values. Effect sizes are reported as efficacy with adjusted 95% CIs. Statistical software is not explicitly named. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks: percentages in Table 1 sum correctly (e.g., 41+59=100). No inconsistencies found.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic errors detected.

Evidence

“P values were based on the log-rank test for the comparison of each L9LS group with the placebo group.”

Statistical analysisFind in source

“The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons).”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: tests named, effect sizes with CIs, and data presentation are adequate. Exact p-values are reported as thresholds, which is acceptable for this trial.

Evidence

“P values were based on the log-rank test for the comparison of each L9LS group with the placebo group.”

Statistical analysisFind in source

ResultsFind in source

“P<0.001 for both comparisons”

ResultsFind in source

The paper mentions 'A data sharing statement provided by the authors is available with the full text of this article at NEJM.org' but does not specify the mechanism or conditions. This is vague and thus reported_but_inadequate. For a clinical trial, repository_deposit and accession_numbers are not applicable for patient-level data, but the data sharing statement should be more concrete. Code sharing is not applicable as no custom code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is mentioned but not detailed; no repository deposit or accession numbers are provided.

Evidence

paraphrase[End of paper]

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

WARNReviewer 2· 80% conf

A data sharing statement is mentioned but not detailed; no repository deposit or accession numbers are provided. Code sharing is not applicable.

Evidence

paraphrase[Supplementary Material]

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

The trial is registered (NCT05304611). Methods are detailed enough for replication. No reporting guideline is explicitly mentioned, but the paper follows CONSORT-like structure. All prespecified outcomes are reported, including secondary and exploratory analyses. Limitations are discussed (e.g., early infections, generalizability). Conclusions are proportional. Funding and COI 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 trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional to the evidence.

Evidence

paraphrase[Supplementary Material]

“ClinicalTrials.gov number, NCT05304611”

paraphrase[Discussion]

“The higher incidence of early infections in the 300-mg group than in the 150-mg group may be related to the higher prevalence of baseline submicroscopic infection in the 300-mg group...”

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Supplementary Material]

“ClinicalTrials.gov number, NCT05304611”

paraphrase[Discussion]

“The higher incidence of early infections in the 300-mg group than in the 150-mg group may be related to the higher prevalence of baseline submicroscopic infection in the 300-mg group...”

“Supported by the Division of Intramural Research and the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.”

Supplementary materialFind in source

Registered (3 IDs: ClinicalTrials.gov). No reporting guideline cited.

ClinicalTrials.gov

NCT05400655

ClinicalTrials.gov

NCT05816330

ClinicalTrials.gov

NCT05304611

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 25 references by DOI: 22 verified — 3 no DOI (shown, not verified).

NO DOI
World malaria report 2023
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Malaria vaccine: WHO position paper — March 2022
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
WHO recommends R21/Matrix-M vaccine for malaria prevention in updated advice on immunization
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

3 data/code links checked; 3 live.

datahttps://clinicaltrials.gov/ct2/show/NCT05400655LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT05816330LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT05304611LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

5 minor

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

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

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

MINORconsistencyAbstract, Results
“P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group.”
→ Ensure consistent use of 'P. falciparum' vs 'Plasmodium falciparum' throughout.
The abstract uses 'P. falciparum' while the introduction uses 'Plasmodium falciparum'.
MINORclarityResults, Efficacy
“Infection was detected at enrollment by means of quantitative reverse-transcriptase–dose of L9LS, in 29 (39%) who received the 300-mg dose of L9LS, and in 27 (36%) who received placebo.”
→ This sentence appears truncated; consider revising for clarity.
The sentence seems incomplete and may be a copy-paste error.
MINORtypoAbstract, Results
“P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group.”
→ Consider adding 'of 75' after each number for clarity, e.g., '36 of 75 participants (48%)'.
Clarity improvement.
MINORconsistencyMethods, Part A
“18 adults would be assigned in open-label fashion to receive L9LS at a dose of 300 mg or 600 mg, administered subcutaneously, or 20 mg per kilogram of body weight, administered intravenously; each group included 6 participants.”
→ Ensure consistent use of 'mg/kg' vs 'mg per kilogram' throughout.
Minor style inconsistency.
MINORgrammarDiscussion
“The results of this trial support the development of antimalarial monoclonal antibodies in other high-risk populations for whom the WHO recommends chemoprevention, including infants and young children, children with severe anemia after hospital discharge, and pregnant persons.”
→ Consider rephrasing to avoid the awkward 'for whom' construction.
Style improvement.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and the findings are well-supported. An informed reader should weigh the minor reporting gaps (vague data sharing, no power analysis, no software named) as transparency issues, but they do not undermine the validity of the trial. No erratum is warranted based on the identified issues.

1.
HIGHdata code
In the Data Availability section, specify the mechanism for requesting de-identified participant data (e.g., via a data access committee or a repository like Vivli) and the conditions/timeframe.
The current statement is vague and does not meet the expectation for a concrete data sharing plan, which is a common reviewer concern.
2.
HIGHreporting
In the Methods, report the power analysis or sample size calculation used to justify the sample size of 225 children.
The absence of a power analysis is a reporting gap that weakens the study design transparency.
3.
HIGHstatistics
In the Statistical Analysis section, explicitly name the statistical software and version used (e.g., R version, SAS version).
Naming the software enhances reproducibility and is expected in clinical trial reporting.
4.
MEDIUMreporting
In the Methods or Supplementary Material, include a statement on adherence to a reporting guideline such as CONSORT and provide the checklist.
Explicitly following a reporting guideline improves transparency and is often required by journals.
5.
MEDIUMstatistics
In the Results, consider reporting exact p-values (e.g., P=0.0002) instead of thresholds (P<0.001) where possible, or state that exact values are in the supplementary materials.
Exact p-values provide more information and are preferred for transparency.
6.
MEDIUMcopyedit
In the Results, Efficacy section, revise the truncated sentence that appears to be a copy-paste error: 'Infection was detected at enrollment by means of quantitative reverse-transcriptase–dose of L9LS...' to a complete, clear statement.
The sentence is incomplete and could confuse readers; it should be corrected for clarity.
7.
MEDIUMcopyedit
In the Abstract and throughout, ensure consistent use of 'P. falciparum' vs 'Plasmodium falciparum'.
Inconsistent terminology is a minor but noticeable copyedit issue.
8.
LOWcopyedit
In the Abstract, consider adding 'of 75' after each number for clarity, e.g., '36 of 75 participants (48%)'.
This improves clarity for readers interpreting the percentages.
9.
LOWcopyedit
In the Methods, Part A, ensure consistent use of 'mg/kg' vs 'mg per kilogram'.
Minor style inconsistency that should be standardized.
10.
LOWcopyedit
In the Discussion, rephrase the sentence 'The results of this trial support the development of antimalarial monoclonal antibodies in other high-risk populations for whom the WHO recommends chemoprevention...' to avoid the awkward 'for whom' construction.
Style improvement for readability.

Full text (39,903 chars)Analyzed: Aug 16, 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.

Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.

DOI

10.1056/NEJMoa2312775

Record issued

2026-08-16

Engine

7.39.0

Exported

2026-09-22