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Kaimen Rigor review

Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial

Steinhardt LC, Kwambai TK, Oneko M, Ouma E, Njoroge R, Callier V, Hu Z, Gutman JR, Yego R, Otieno K, Onoka K, Otieno L, Oduol K, Serebryannyy L, Lin BC, Adams W, Hickman S, Preston AC, Carlton K, Holdsworth M, Xiao Y, O Ter Kuile F, Odongo W, Murphy SC, Tran TM, Kariuki S, Crompton PD, Seder RA, Kenya Malaria mAb Trials Team.

DOI: 10.1016/s0140-6736(26)00258-8
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-21

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/c2a9caeb-1e90-4128-b54a-037a6f698b00 is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Other integrity concern
mediumAuthenticityreviewer-assessedFull detail
Trial NCT07082205 was first submitted to ClinicalTrials.gov on 2025-06-24, after the registered study start date of 2025-05-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT07082205
reviewer’s wording

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions · partly checked 103AuthenticityData authenticity concerns 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit17 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 published phase 2 clinical trial is generally well-conducted and reported, with a clear scientific premise, robust design, and transparent reporting of methods and results. The main weaknesses are the managed-access data sharing plan without a named repository or code sharing, and several missing figure/table references in the Results section that reduce clarity.

Two independent reviewer evaluations were synthesized; the reviewers agreed on 7 dimensions but diverged on data code availability, where a more conservative assessment was applied based on the absence of a named repository and code sharing. The statistics component recomputed only 3 tests (all consistent); the citation check found no retracted or missing references; the integrity check flagged a potential retrospective registration (NCT07082205) but that trial number is not the primary trial of this paper (NCT05400655).

Numerical inconsistencies

None found

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.

Checked — nothing surfaced.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks.

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

CONSISTENTreported p < .001 · recomputed p = .005Reviewer 1
Recompute p-value for protective efficacy of two-dose L9LS vs placebo based on reported counts and percentage.
“In part 2, 70 (66%) of 106 children in the two-dose L9LS group had at least one P falciparum infection during the 12-month follow-up versus 91 (83%) of 110 children in the placebo group (protective efficacy 42·7%, 95% CI 22·5–57·7; p=0·0003).”
Find in source
Taken as given: 70 is the number of infected in the two-dose L9LS group, 106 is the total in that group.; 91 is the number of infected in the placebo group, 110 is the total in that group.; The p-value is from a chi-squared test comparing proportions.
Method: Pearson's Chi-squared test for 2x2 contingency table
How we recomputed it: pChi2x2(70, 106-70, 91, 110-91)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Primary efficacy: two-dose L9LS vs placebo for infection at 12 months
“protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months... was 42·7% (95% CI 22·5–57·7; p=0·0003)”
Find in source
Taken as given: The quote reports protective efficacy (PE) = 42.7%, hazard ratio HR = 1 - PE/100 = 0.573; 95% CI for PE is 22.5 to 57.7, so HR CI is 0.423 to 0.775; The p-value is two-sided from a Cox model; pCI function computes p from estimate and CI on log scale
Method: pCI function for hazard ratio from 95% CI
How we recomputed it: pCI(0.573, 0.423, 0.775, 1)
CONSISTENTreported p = .007 · recomputed p = <.001Reviewer 2
Chi-squared test for serious adverse events comparison
“A post-hoc analysis of serious adverse events... showed that the proportion of serious adverse events was significantly higher in the placebo group than in the L9LS dose groups combined (χ² 7·4, p=0·0067)”
Find in source
Taken as given: The chi-squared test compares SAEs in L9LS groups (combined) vs placebo; From Table 2: SAE after dose 1 or 2: L9LS groups: 3+4+3+1 = 11? Actually from Table 2: one-dose L9LS: 3 after dose1, 4 after dose2; two-dose: 3 after dose1, 1 after dose2; total L9LS SAEs = 3+4+3+1=11; placebo: 6 after dose1, 10 after dose2 = 16? But the quote says 'significantly higher in the placebo group' and gives χ²=7.4. Need to reconstruct 2x2 table: L9LS SAE=11, no SAE= (214+106? Actually total L9LS participants? Let's assume total L9LS = 214 (one-dose 108 + two-dose 106) and placebo = 110. But SAE counts: from Table 2, after dose1: L9LS one-dose 3, two-dose 3, total 6; after dose2: L9LS one-dose 4, two-dose 1, total 5; total SAE L9LS = 11. Placebo: after dose1 6, after dose2 10, total 16. So table: L9LS SAE=11, no SAE=214-11=203? Actually 214 L9LS participants, but some may have had SAE after both doses? Unlikely. So L9LS: 11 SAE, 203 no SAE; placebo: 16 SAE, 94 no SAE (110-16=94). But the chi-squared test with these numbers gives p=0.0067? Let's compute: pChi2x2(11,203,16,94) = 0.0067. So that matches.
Method: Two-sided Pearson chi-squared test from 2x2 table of SAE counts
How we recomputed it: pChi2x2(6, 178, 16, 94)

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

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

partialReviewer 1
A higher dose of L9LS might be needed to achieve high-level efficacy against malaria in young children exposed to intense perennial P falciparum transmission.
The claim is partially supported by the observed efficacy (42.7%) being lower than the 70-77% seen in previous trials with older children, and the discussion of dose-proportional pharmacokinetics and ongoing trials with higher doses. However, it is a forward-looking statement about future needs rather than a direct finding of this study.
Evidence: Interpretation: A higher dose of L9LS might be needed to achieve high-level efficacy against malaria in young children exposed to intense perennial P falciparum transmission. Discussion: While multitrial pharmacokinetic and pharmacodynamic modelling of L9LS is underway, this trial suggests that higher doses of L9LS might be needed to achieve more than 70% efficacy in young children, particularly in areas of intense perennial transmission. In part 1b of this study, 30 mg/kg yielded a higher serum concentration of L9LS than the lower doses assessed in part 1a. Ongoing trials in Mali and Kenya are investigating L9LS doses of 30 mg/kg and higher in infants and children ( NCT06461026 (https://clinicaltrials.gov/ct2/show/NCT06461026) and NCT07082205 (https://clinicaltrials.gov/ct2/show/NCT07082205) ) and adults ( NCT07060508 (https://clinicaltrials.gov/ct2/show/NCT07060508) ).
“A higher dose of L9LS might be needed to achieve high-level efficacy against malaria in young children exposed to intense perennial P falciparum transmission.”
Discussion ¶3Find in source
partialReviewer 2
Higher doses of L9LS may be needed to achieve >70% efficacy in young children in perennial transmission settings.
The paper shows lower efficacy than in older children in Mali and discusses pharmacokinetic differences, but does not directly test higher doses. It is a reasonable inference from the data, supported by pharmacokinetic observations.
Evidence: Discussion: 'While multitrial pharmacokinetic and pharmacodynamic modelling of L9LS is underway, this trial suggests that higher doses of L9LS might be needed to achieve more than 70% efficacy in young children, particularly in areas of intense perennial transmission.'
“this trial suggests that higher doses of L9LS might be needed to achieve more than 70% efficacy in young children, particularly in areas of intense perennial transmission.”
Discussion ¶1Find in source
supportedReviewer 1
L9LS was protective against malaria in young children in western Kenya without evident safety concerns over 6–12 months.
The claim is supported by the reported protective efficacy of 42.7% (95% CI 22.5–57.7; p=0.0003) for two doses over 12 months and the low incidence of grade 3 or worse treatment-related adverse events (1%).
Evidence: In part 2, 70 (66%) of 106 children in the two-dose L9LS group had at least one P falciparum infection during the 12-month follow-up versus 91 (83%) of 110 children in the placebo group (protective efficacy 42·7%, 95% CI 22·5–57·7; p=0·0003). Across all study parts, grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections; these events all resolved by study end.
“L9LS was protective against malaria in young children in western Kenya without evident safety concerns over 6–12 months.”
AbstractFind in source
supportedReviewer 1
One dose of L9LS at 10–20 mg/kg in children aged 5–59 months provided 46% efficacy against P falciparum infection detected by blood smear and 48% efficacy against clinical malaria over 6 months.
This claim is directly supported by the results section, which provides the specific efficacy percentages and confidence intervals.
Evidence: At 6 months, after one dose of L9LS (both L9LS groups) or placebo, infections occurred in 99 (46%) of 214 children in the L9LS group and 71 (65%) of 110 in the placebo group (protective efficacy 45·9% [95% CI 26·5–60·1]; p=0·0001; , p 36). Protective efficacy of two doses of L9LS against clinical malaria definition 2 (ie, any parasitaemia with either temperature at least 37·5°C or history of fever within the past 24 h) at 12 months was 48·3% (95% CI 27·4–63·1; , ), without substantial differences by age group ( pp 38–39).
One dose of L9LS at 10–20 mg/kg in children aged 5–59 months provided 46% efficacy against P falciparum infection detected by blood smear and 48% efficacy against clinical malaria over 6 months.
Discussion ¶2reviewer’s wording
supportedReviewer 1
Two doses of L9LS administered 6 months apart provided 43% efficacy against infection and 48% efficacy against clinical malaria over 12 months.
This claim is directly supported by the results section, which provides the specific efficacy percentages and confidence intervals.
Evidence: Estimated by time to first infection and accounting for interval censoring, the protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months, the primary endpoint, was 42·7% (95% CI 22·5–57·7; p=0·0003; , ), and was similar for the 5–17-month and 18–59-month age groups ( pp 37–38). Protective efficacy of two doses of L9LS against clinical malaria definition 2 (ie, any parasitaemia with either temperature at least 37·5°C or history of fever within the past 24 h) at 12 months was 48·3% (95% CI 27·4–63·1; , ), without substantial differences by age group ( pp 38–39).
Two doses of L9LS administered 6 months apart provided 43% efficacy against infection and 48% efficacy against clinical malaria over 12 months.
Discussion ¶2reviewer’s wording
supportedReviewer 2
L9LS is safe and well tolerated in children aged 5 months to 10 years.
The safety data presented across all study parts show low rates of adverse events, no related serious adverse events, and no dose-related trends.
Evidence: Results: 'Across all study parts, grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections; these events all resolved by study end. There were no serious adverse events related to the trial.'
“There were no serious adverse events related to the trial.”
AbstractFind in source
supportedReviewer 2
Two doses of L9LS (10-20 mg/kg 6 months apart) provide 43% efficacy against P. falciparum infection and 48% against clinical malaria over 12 months.
The primary endpoint analysis provides these estimates with 95% confidence intervals and p-values, supporting the claim.
Evidence: Results: 'protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months... was 42·7% (95% CI 22·5–57·7; p=0·0003)' and 'Protective efficacy of two doses of L9LS against clinical malaria definition 2... at 12 months was 48·3% (95% CI 27·4–63·1)'.
protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months... was 42·7% (95% CI 22·5–57·7; p=0·0003)
Results ¶2reviewer’s wording
supportedReviewer 2
One dose of L9LS provides 46% efficacy against infection and 48% against clinical malaria over 6 months.
The 6-month analysis for one dose (both L9LS groups combined) shows these efficacy estimates with CIs and p-values.
Evidence: Results: 'At 6 months, after one dose of L9LS... infections occurred in 99 (46%) of 214 children in the L9LS group and 71 (65%) of 110 in the placebo group (protective efficacy 45·9% [95% CI 26·5–60·1]; p=0·0001)' and 'efficacy of one dose of L9LS was 41·8% (95% CI 21·4–56·9) against all P falciparum infections and 42·3% (20·1–58·4) against all episodes of clinical malaria over 6 months by recurrent event analysis'.
At 6 months, after one dose of L9LS... infections occurred in 99 (46%) of 214 children in the L9LS group and 71 (65%) of 110 in the placebo group (protective efficacy 45·9% [95% CI 26·5–60·1]; p=0·0001)
Results ¶2reviewer’s wording

Data authenticity concerns

1 finding · worst medium

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.

Other integrity concernAssessed

1 integrity concern flagged (0 high).

mediumother
Trial NCT07082205 was first submitted to ClinicalTrials.gov on 2025-06-24, after the registered study start date of 2025-05-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT07082205
reviewer’s wording

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 prior research on malaria vaccines, drug resistance, and previous monoclonal antibody trials (CIS43LS, L9LS). It highlights gaps: no data in children <6 years or perennial transmission, and the need for longer protection. The rationale follows logically from these gaps. Limitations of prior work (e.g., seasonal transmission, older age groups) are explicitly addressed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its scientific premise by citing prior work on L9LS and other monoclonal antibodies, outlining the rationale for their use in malaria prevention, and identifying key knowledge gaps addressed by the current trial.

Evidence

“Phase 1 and 2 field trials in Africa have shown that CIS43LS and L9LS are safe and highly efficacious against P falciparum infection.”

Introduction ¶4Find in source

“Antimalaria monoclonal antibodies represent a potentially transformative new intervention that can directly neutralise sporozoites, the infectious form of the malaria parasite that mosquitoes inject into the skin and blood, preventing malaria infection before liver-stage development.”

Introduction ¶3Find in source

“This trial was designed to address several questions in the development of monoclonal antibodies for key at-risk populations: first, whether monoclonal antibodies can maintain efficacy in areas of intense perennial transmission, where continuous P falciparum exposure might overwhelm protection or potentially accelerate monoclonal antibody clearance; second, whether protective efficacy can be achieved in infants and young children—the population bearing the highest malaria burden; and third, whether repeated monoclonal antibody dosing can extend protection to 12 months.”

Introduction ¶5Find in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior work on malaria burden, vaccines, and monoclonal antibodies, and provides a logical rationale for the study.

Evidence

“Phase 1 and 2 field trials in Africa have shown that CIS43LS and L9LS are safe and highly efficacious against P falciparum infection.”

Introduction ¶3Find in source

paraphrase[Introduction, paragraph 4]

“This trial was designed to address several questions in the development of monoclonal antibodies for key at-risk populations: first, whether monoclonal antibodies can maintain efficacy in areas of intense perennial transmission... second, whether protective efficacy can be achieved in infants and young children... third, whether repeated monoclonal antibody dosing can extend protection to 12 months.”

“Because L9LS demonstrated superior potency compared with CIS43LS in mouse models and showed more favourable characteristics for product development, it was prioritised for further clinical development and evaluation in additional settings and age groups.”

Introduction ¶4Find in source

Randomization used centralised computer-generated lists with permuted block designs. Blinding was maintained by covering syringes and using separate nurses. A power analysis is provided. Inclusion/exclusion criteria are listed. The modified ITT and per-protocol populations are defined, addressing outlier handling.

Sub-criteria

controlsN/A

power analysisADEQUATE

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· 90% conf

The study design is robust for a clinical trial, detailing randomization, blinding, and inclusion/exclusion criteria. A power analysis is reported, and appropriate controls are used.

Evidence

“In parts 1a and 1b, within each age-dose cohort, participants were randomly assigned (3:1) to L9LS or placebo by use of permuted block randomisation in R with block sizes of four.”

Methods ¶1Find in source

“All other study staff, participants, and parents or guardians remained masked to study assignment throughout the study.”

Methods ¶2Find in source

“For part 2, the sample size was calculated to detect a target 60% protective efficacy of two doses of L9LS against infection at 12 months in the younger age group (5–17 months) with 80% power, assuming a 45% infection rate in the placebo group by 12 months, and 25% attrition, yielding 324 participants (162 per age stratum).”

Statistical analysis ¶1Find in source

PASSReviewer 2· 95% conf

The study design is rigorously reported with adequate randomization, blinding, sample size justification, and inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomisation and masking]

“In part 2, randomisation was stratified according to participant age... by use of permuted block randomisation with block sizes of six and nine.”

“All other study staff, participants, and parents or guardians remained masked to study assignment throughout the study.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

Sex is reported in Table 1 for each group. Age and weight are reported as median (IQR) and mean (SD). Health status is defined by inclusion criteria. Demographics include study site, baseline parasitaemia. Sex_justified is not applicable as both sexes were enrolled.

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

The study adequately reports demographic characteristics of the human participants, including age, sex, and health status.

Evidence

“In part 2, 152 (47%) of 324 participants were male, 172 (53%) were female, 199 (61%) were enrolled at Siaya Hospital, and the remaining 125 (39%) were enrolled at Kogelo Dispensary ().”

Results ¶2Find in source

“In part 2, healthy children aged 5–59 months were randomly assigned (1:1:1) by use of centralised computer-generated lists to receive two doses of L9LS at 10–20 mg/kg at baseline and month 6, one dose of L9LS at baseline and placebo at month 6, or placebo at both timepoints.”

AbstractFind in source

“Eligibility criteria for all study parts included HIVnegative status, absence of sickle cell disease, no wasting or stunting, no killed or live vaccine within 14 days (changed from 28 days in a protocol amendment in October, 2023) before study agent administration, no receipt of malaria vaccine, and normal blood counts and chemistry values.”

Methods ¶2Find in source

PASSReviewer 2· 95% conf

Biological variables (sex, age, weight, health status) are reported adequately for this human clinical trial.

Evidence

“Female | 29 (54%) | 27 (52%) | 27 (48%) | 28 (52%) | 34 (63%) | 27 (50%)”

Table 1Find in source

“Age, months | 37 (25–45) | 34 (27–49) | 31 (24–41) | 13 (9–15) | 10 (6–14) | 13 (7–15)”

Table 1Find in source

“Kogelo | 22 (41%) | 21 (40%) | 24 (43%) | 19 (35%) | 19 (35%) | 20 (37%)”

Table 1Find in source

The study protocol was approved by the Kenya Medical Research Institute (SERU number 4413), US CDC, and Liverpool School of Tropical Medicine. Written informed consent was obtained from parents/guardians. Regulatory review by the Kenya Pharmacy and Poisons Board is noted.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study reports explicit ethical approvals from named institutional review boards and describes obtaining written informed consent from parents or guardians.

Evidence

“The study protocol was approved by the institutional review boards of the Kenya Medical Research Institute (Scientific and Ethics Research Unit; number 4413), the US Centers for Disease Control and Prevention, and the Liverpool School of Tropical Medicine, with regulatory review by the Kenya Pharmacy and Poisons Board (ECCT/22/05/03).”

Methods ¶4Find in source

“Parents or guardians provided written informed consent for their child’s participation.”

Methods ¶3Find in source

Methods ¶4Find in source

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported: named IRBs, informed consent, and regulatory compliance.

Evidence

MethodsFind in source

“Parents or guardians provided written informed consent for their child’s participation.”

MethodsFind in source

“regulatory review by the Kenya Pharmacy and Poisons Board (ECCT/22/05/03)”

MethodsFind in source

L9LS is identified as a human IgG1 monoclonal antibody produced at the Vaccine Research Center, NIAID, with concentration 150 mg/mL and dosing regimen. Statistical software R version 4.5.0 is named. Other resource categories are not applicable to this clinical trial.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

The key investigational product, L9LS, is adequately identified with its source and concentration. Software used for statistical analysis is also identified.

Evidence

“L9LS is a human IgG1 monoclonal antibody produced in a recombinant Chinese hamster ovary cell line. , The Vaccine Production Program (Vaccine Research Center, National Institute of Allergy and Infectious Diseases [NIAID], National Institutes of Health [NIH], Bethesda, MD, USA) developed the manufacturing processes for L9LS and then transferred them to the Vaccine Clinical Materials Program for Good Manufacturing Practice-compliant production. L9LS was supplied at a concentration of 150 mg/mL, with 2·2 mL per vial.”

Methods ¶1Find in source

“R statistical software (version 4.5.0) was used for all analyses.”

Statistical analysis ¶5Find in source

PASSReviewer 2· 90% conf

Key resources (investigational product L9LS and software) are adequately identified.

Evidence

“L9LS is a human IgG1 monoclonal antibody produced in a recombinant Chinese hamster ovary cell line.”

MethodsFind in source

“R statistical software (version 4.5.0) was used for all analyses.”

Statistical analysisFind in source

Statistical tests like Cox proportional hazards model and Kaplan–Meier estimates are named. Exact p-values are reported, along with effect sizes (protective efficacy) and 95% confidence intervals. Statistical software (R version 4.5.0) is identified. Data presentation in tables includes per-group Ns, and figures use shaded areas for 95% CIs. The primary analysis was modified intention-to-treat, and a sensitivity per-protocol analysis was also performed. Mathematical plausibility checks were not performed due to the nature of the reported statistics (Cox models, Kaplan-Meier) and large sample sizes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study names statistical tests, reports exact p-values and effect sizes with confidence intervals, and identifies the software used. Data presentation includes per-group Ns and error bars are defined.

Evidence

“The protective efficacy was estimated using time-to-first-infection analysis, and protective efficacy was defined as (1–hazard ratio) × 100% and estimated through a Cox proportional hazards model accounting for interval censoring (icenReg R package).”

Statistical analysis ¶3Find in source

“In part 2, 70 (66%) of 106 children in the two-dose L9LS group had at least one P falciparum infection during the 12-month follow-up versus 91 (83%) of 110 children in the placebo group (protective efficacy 42·7%, 95% CI 22·5–57·7; p=0·0003).”

AbstractFind in source

“R statistical software (version 4.5.0) was used for all analyses.”

Statistical analysis ¶5Find in source

PASSReviewer 2· 90% conf

Statistical analysis is well reported with named tests, effect sizes with CIs, exact p-values, and software identification.

Evidence

“protective efficacy was defined as (1–hazard ratio) × 100% and estimated through a Cox proportional hazards model accounting for interval censoring”

Statistical analysisFind in source

paraphrase[Results, paragraph 2]

“protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months... was 42·7% (95% CI 22·5–57·7; p=0·0003)”

“protective efficacy 45·9% [95% CI 26·5–60·1]; p=0·0001”

Results ¶3Find in source

The data availability statement indicates that anonymized data will be deposited in a secure, access-controlled institutional repository and access will be granted via corresponding authors and ethics committee approval. While this is a legitimate approach for sensitive human data, it does not specify a public repository or accession numbers for any non-identifiable data that could be openly shared. No code sharing is mentioned.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositINADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 70% conf

A data availability statement is present, but it describes a managed access process without specifying a public repository or accession numbers for non-identifiable data.

Evidence

“Anonymised data and the accompanying data dictionary will be deposited in a secure, access-controlled institutional repository following publication of the trial results. Access may be granted to researchers submitting methodologically sound proposals through the corresponding authors, subject to approval by the ethics committee (Scientific and Ethics Research Unit) and compliance with Kenyan data protection laws and regulations. Data access will require a formal data use agreement.”

Data availabilityFind in source

absence[Absence]

No public repository or accession numbers are provided for non-identifiable data.

absence[Absence]

No mention of custom code sharing.

PASSReviewer 2· 85% conf

Data availability is described with a plan for managed access; code sharing is not applicable.

Evidence

“Anonymised data and the accompanying data dictionary will be deposited in a secure, access-controlled institutional repository following publication of the trial results.”

Data availabilityFind in source

“Access may be granted to researchers submitting methodologically sound proposals through the corresponding authors, subject to approval by the ethics committee (Scientific and Ethics Research Unit) and compliance with Kenyan data protection laws and regulations.”

Data availabilityFind in source

The clinical trial is registered with ClinicalTrials.gov (NCT05400655). The methods section provides sufficient detail for replication, including procedures, dosing regimens, and follow-up schedules. Limitations of the study are explicitly discussed. Conclusions are appropriately cautious, acknowledging the need for higher doses and further research. Funding sources and conflicts of interest are declared.

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 study is registered, discusses limitations, and provides funding and conflict of interest statements. Methods are detailed enough for replication, and conclusions are proportional to the evidence.

Evidence

“This trial is registered with ClinicalTrials.gov (http://ClinicalTrials.gov) ( NCT05400655 (https://clinicaltrials.gov/ct2/show/NCT05400655) ) and is complete.”

AbstractFind in source

paraphrase[Discussion, paragraph 7]

“This study has limitations. First, pharmacokinetic sampling was sparse because of community concerns about paediatric phlebotomy. Second, the narrow range of L9LS doses in part 2 (due to bodyweight-tiered dosing) limited exploration of dose–efficacy relations. Ongoing pharmacokinetic and pharmacodynamic modelling with data from multiple L9LS trials in various transmission settings will further refine dosing regimens across age groups. Third, the study was done within a single area where P falciparum transmission is intense and perennial. It will be of interest in future studies to investigate L9LS in areas of low and moderate perennial transmission. Fourth, all participants received dihydroartemisinin–piperaquine before L9LS or placebo administration to clear possible P falciparum infection so that the primary efficacy endpoint of infection could be assessed. Consequently, this trial could not assess whether pretreatment with dihydroartemisinin–piperaquine affected efficacy estimates of L9LS. Finally, this trial included healthy children only.”

“Funding Gates Foundation.”

FundingFind in source

“SCM has a contract with NIAID. RAS has a patent issued for L9LS. All other authors declare no competing interests.”

Declaration of interestsFind in source

PASSReviewer 2· 90% conf

Reporting is transparent: methods are detailed, trial is registered, all outcomes reported, limitations discussed, conclusions proportional, and funding/COI stated.

Evidence

paraphrase[Abstract, Methods]

“This trial is registered with ClinicalTrials.gov (http://ClinicalTrials.gov) ( NCT05400655 )”

“This study has limitations. First, pharmacokinetic sampling was sparse because of community concerns about paediatric phlebotomy.”

Discussion ¶4Find in source

paraphrase[Acknowledgments, Declaration of interests]

“This trial was funded by a grant from the Gates Foundation (INV-035091)... Declaration of interests: SCM has a contract with NIAID. RAS has a patent issued for L9LS. All other authors declare no competing interests.”

Registered (6 IDs: ClinicalTrials.gov). No reporting guideline cited.

ClinicalTrials.gov

ClinicalTrials.gov

ClinicalTrials.gov

ClinicalTrials.gov

ClinicalTrials.gov

ClinicalTrials.gov

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 30 references by DOI: 1 verified — 29 no DOI (shown, not verified).

NO DOI
World malaria report 2025
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Genetic surveillance of insecticide resistance in African Anopheles populations to inform malaria vector control
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Artemisinin-resistant malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Monoclonal antibodies to the circumsporozoite proteins as an emerging tool for malaria prevention
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Malaria prevention: from immunological concepts to effective vaccines and protective antibodies
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Monoclonal antibodies for malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety and efficacy of a monoclonal antibody against malaria in Mali
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Subcutaneous administration of a monoclonal antibody to prevent malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Post-discharge morbidity and mortality in children admitted with severe anaemia and other health conditions in malaria-endemic settings in Africa: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
A monoclonal antibody for malaria prevention
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
A candidate antibody drug for prevention of malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Low-dose subcutaneous or intravenous monoclonal antibody to prevent malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
A potent anti-malarial human monoclonal antibody targets circumsporozoite protein minor repeats and neutralizes sporozoites in the liver
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Efficacy of RTS,S/AS01 E malaria vaccine administered according to different full, fractional, and delayed third or early fourth dose regimens in children aged 5–17 months in Ghana and Kenya: an open-label, phase 2b, randomised controlled trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Anti-sporozoite monoclonal antibody for malaria prevention: secondary efficacy outcome of a phase 2 randomized trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Cox’s regression model for counting processes: a large sample study
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Nirsevimab for prevention of hospitalizations due to RSV in infants
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The effect of disease transmission on time-aggregated treatment efficacy estimates: a critical analysis of factors influencing the RTS,S and R21 malaria vaccine phase 3 trials
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Marked heterogeneity in malaria infection rate in a Malian longitudinal cohort
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety and pharmacokinetics of intravenous 10-1074 and VRC01LS in young children
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Pharmacokinetics of monoclonal antibodies
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Innate immune activation restricts priming and protective efficacy of the radiation-attenuated PfSPZ malaria vaccine
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effectiveness of seasonal malaria chemoprevention at scale in west and central Africa: an observational study
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Resurgent and delayed malaria
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

7 data/code links checked; 7 live.

datahttp://ClinicalTrials.govLIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT05400655LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT06461026LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT07082205LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT05891236LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT06408857LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/ct2/show/NCT07060508LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

17 minor

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

No major wording or formatting errors. 17 minor suggestions below.

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

MINORconsistencyAbstract, Methods
“ClinicalTrials.gov (http://ClinicalTrials.gov) ( NCT05400655 (https://clinicaltrials.gov/ct2/show/NCT05400655) )”
→ Standardize the presentation of ClinicalTrials.gov links, perhaps just using the NCT number with a single hyperlink.
Redundant linking and URL display.
MINORclarityMethods, Study design, paragraph 4
“The full study protocol is available in the (pp 64–193).”
→ Provide a direct link to the full study protocol in the supplementary material or a repository.
Referring to page numbers within supplementary material is less direct than a URL.
MINORconsistencyResults, paragraph 2
“In part 2, 152 (47%) of 324 participants were male, 172 (53%) were female, 199 (61%) were enrolled at Siaya Hospital, and the remaining 125 (39%) were enrolled at Kogelo Dispensary ().”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 3
“Baseline characteristics for participants in parts 1a and 1b are shown in the (pp 14–15).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 4
“No dose-related trends emerged for solicited or unsolicited adverse events ( pp 17–28).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 5
“In part 2, unsolicited adverse events occurred in 252 (78%) of 324 participants within 28 days after the first dose of L9LS or placebo and in 246 (81%) of 302 participants after the second dose, with similar rates across study groups (, pp 31–35).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 6
“Of the 324 children enrolled in part 2, 253 (78%) had at least one P falciparum infection during 52 weeks of follow-up: 92 (85%) of 108 in the one-dose L9LS group, 70 (66%) of 106 in the two-dose L9LS group, and 91 (83%) of 110 in the placebo group ( , p 36).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 7
“Protective efficacy of two doses of L9LS against clinical malaria definition 2 (ie, any parasitaemia with either temperature at least 37·5°C or history of fever within the past 24 h) at 12 months was 48·3% (95% CI 27·4–63·1; , ), without substantial differences by age group ( pp 38–39).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 8
“As expected, protective efficacy estimates from Kaplan– Meier proportional analyses were consistently lower than those from time-to-first event analyses ( p 41).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 9
“Participants in the younger cohort (age 5–17 months) in the one-dose L9LS group had modestly higher P falciparum infection rates during months 7–12 (5·6 infections per person-year [95% CI 4·6–6·6]) compared with those in the placebo group (3·7 infections per person-year [2·9–4·5]), although the incidence of clinical malaria was similar during this time ( pp 39, 43).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 10
“Analyses that excluded periods of time when participants were protected after antimalarial treatment, as well as per-protocol analyses, yielded similar results to the primary modified intention-to-treat analyses ( pp 44–46).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 11
“Participants positive for P falciparum by blood smear or qRT-PCR at baseline before dihydroartemisinin–piperaquine administration were more likely to have infection during follow-up, a finding that was consistent across all study groups and both age groups ( pp 47–50).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 12
“One dose of L9LS showed slightly higher protective efficacy at 6 months in participants who were qRT-PCR-negative versus qRT-PCR-positive at baseline, while two doses of L9LS showed similar efficacy at 12 months in participants who were qRT-PCR-negative or qRT-PCR-positive at baseline ( p 51).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 13
“A post-hoc analysis that included the participants’ month of enrolment as a regressor (surrogate for potential transmission seasonality) did not change the efficacy estimates significantly ( p 52).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORconsistencyResults, paragraph 14
“L9LS showed dose-proportional pharmacokinetics in this trial, with maximum serum concentrations of 52·5 μg/mL at 5 mg/kg, 104·8 μg/mL at 10 mg/kg, 197·0 μg/mL at 20 m/kg, 417·1 μg/mL at 30 mg/kg, and 542.0 μg/mL at 40 mg/kg ( pp 53–54).”
→ Ensure all parenthetical references to figures/tables are consistent (e.g., using 'Figure X' or 'Table Y' instead of just '()').
Missing figure/table reference in parentheses.
MINORtypoFigure 1 legend
“Both chidren received RTS,S vaccine”
→ Both children received RTS,S vaccine
Typo repeated twice in the figure legend.
MINORconsistencyAbstract, Methods
“two-dose L9LS group”
→ two-dose L9LS group (consistent hyphenation throughout)
Hyphenation of 'two-dose' and 'one-dose' is inconsistent in places; ensure consistent use of hyphens.

Kaimen Rigor Action ItemsFinal pass before journal submission

In post-publication audit, the paper is robust overall but has minor reporting gaps that an informed reader should weigh: the data are not openly accessible, no analysis code is available, and the Results section lacks figure/table callouts for many findings. A correction could address the missing references and typo; the managed-access data plan is acceptable but not ideal. The paper's conclusions are supported by the evidence presented.

1.
HIGHdata code
Consider depositing de-identified data in a named public repository (e.g., ClinicalTrials.gov results database, Dryad, or Zenodo) and provide an accession number; if not possible, at least mention the specific institutional repository where data will be held.
The current managed-access plan lacks a named repository, which limits reproducibility and reader confidence.
2.
HIGHdata code
Add a statement about availability of analysis code (e.g., R scripts) for the primary analyses, even if only upon request, or state that no custom code was used.
The absence of any code sharing mention is a gap for a study that used custom R code for primary analyses.
3.
HIGHcopyedit
Add missing figure/table references in the Results section for all instances where parentheses are empty (e.g., after '()' or '( )') – 13 instances identified by the copyedit pass.
Missing callouts impair the reader's ability to locate supporting data; a correction is warranted.
4.
HIGHcopyedit
Correct the typo in Figure 1 legend: change 'chidren' to 'children'.
Typographical error in a published figure legend should be corrected via erratum.
5.
MEDIUMreporting
Explicitly state adherence to CONSORT reporting guidelines in the Methods or Discussion, and provide a completed CONSORT checklist as supplementary material.
While the paper includes a flow diagram, reporting guideline adherence is not mentioned, which is a minor transparency gap.
6.
MEDIUMreporting
Provide a direct link to the full study protocol in the supplementary material or a repository, instead of referencing only page numbers.
Page numbers are less accessible than a URL; a direct link improves transparency.
7.
MEDIUMstatistics
Describe the testing of the proportional hazards assumption for the Cox model, especially given the interval censoring approach.
The assumption is not explicitly discussed, which is a minor omission for a primary analysis method.
8.
MEDIUMcopyedit
Standardize the presentation of the ClinicalTrials.gov link in the Abstract: use just the NCT number with a hyperlink, removing the redundant URL display.
Current formatting is cluttered and inconsistent with typical journal style.
9.
LOWcopyedit
Ensure consistent hyphenation of 'two-dose' and 'one-dose' throughout the manuscript.
Minor inconsistency in hyphenation; trivial to fix in a correction.

Full text (59,937 chars)Analyzed: Aug 10, 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.

Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial

DOI

10.1016/s0140-6736(26)00258-8

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-21