Effectiveness of the RTS,S/AS01E malaria vaccine in a real-world setting over 1 year of follow-up after the three-dose primary schedule: an interim analysis of a phase 4 study in Ghana, Kenya, and Malawi
Bibliographic record
Abstract
Background RTS,S/AS01 E was first introduced within the Malaria Vaccine Implementation Programme in selected areas in Ghana, Kenya, and Malawi. A series of post-introduction observational studies were initiated in these areas to assess RTS,S/AS01 E safety and effectiveness in real-world settings. Here, we report the results of the interim analysis of the EPI-MAL-003 study secondary objectives related to vaccine effectiveness. Methods EPI-MAL-003 was a phase 4, disease surveillance study with prospective cohort event monitoring. The study was performed in routine medical practice settings at 12 sites (four per country) in Ghana, Kenya, and Malawi. Children younger than 18 months were enrolled in exposed clusters (sites where RTS,S/AS01 E was introduced) and unexposed clusters; data were collected via active surveillance. In an interim analysis, we estimated the effect of vaccination on the incidence of malaria, all-cause hospitalisations, and malaria-related hospitalisations, the prevalence of anaemia among hospitalised children, and mortality over 1 year of follow-up after primary vaccination with three RTS,S/AS01 E doses. These endpoints were analysed in the effectiveness analysis set. The primary endpoints are reported elsewhere, together with secondary safety endpoints. This study is registered with ClinicalTrials.gov, NCT03855995, and is completed. Findings The first child was enrolled on March 21, 2019, and the cutoff date for the current analysis was Nov 2, 2023. 45 000 children were enrolled (22 426 [49·8%] were female and 22 574 [50·25%] were male). 39 463 children were included in the analyses. When comparing vaccinated children from exposed clusters with unvaccinated children from unexposed clusters, country-adjusted incidence rate ratios were 0·70 (95% CI 0·67–0·73; p<0·001) for any malaria, 0·42 (0·30–0·60; p<0·001) for severe malaria, 0·64 (0·56–0·72; p<0·001) for malaria-related hospitalisations, 0·79 (0·74–0·84; p<0·001) for all-cause hospitalisations, and 0·83 (0·64–1·09; p=0·18) for all-cause mortality. The adjusted odds ratio for the prevalence of anaemia among children who were hospitalised (vaccinated children from exposed clusters vs unvaccinated children from unexposed clusters) was 0·81 (95% CI 0·73–0·90; p<0·001). Similar trends were observed in a before–after comparison with unvaccinated children enrolled in the EPI-MAL-002 study conducted before the RTS,S/AS01 E introduction. Interpretation Over 1 year of follow-up after the third vaccine dose, vaccination with RTS,S/AS01 E in real-world settings showed significant reductions in malaria burden. These findings reinforce the continued use of RTS,S/AS01 E vaccination in children as an effective public health measure to reduce malaria-related illness and mortality in endemic regions, and highlight its relevance for future malaria control strategies. Funding GSK.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".