| Title: |
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. |
| Authors: |
Ndeketa, Latif; Haine, Valérie; Debois, Muriel; Asante, Kwaku Poku; Agyapong, Prince Darko; Kaali, Seyram; Devadiga, Raghavendra; Harrison, Samuel BE; Boahen, Owusu; French, Neil; Kayan, Kingsley; Ogutu, Bernhards; Adeniji, Elisha; Kariuki, Simon; Owusu-Agyei, Seth; Olewe, Fredrick; Jere, Tikhala Makhaza; Maleta, Kenneth; Mategula, Donnie; Mzanga, Phylis; Phiri, Vincent Katunga; Ansah, Patrick Odum; Orimbo, John; Ansah, Nana Akosua; Orsini, Mattea; Ong'echa, John Michael; Oduro, Abraham Rexford; Sifuna, Peter M; Azongo, Daniel K; Otieno, Walter; Bangre, Oscar; Kaburise, Michael Bandasua; Ababio, Lucy Osei; Oyieko, Janet Nyawira; Sing'oei, Valentine; Amoit, Stellah Kevyne; Nyangulu, Wongani; Schuerman, Lode; Awuni, Denis; Ochieng, Benard Omondi; Onyango, Irene; Odera-Ojwang, Patricia; Oguk, Esther Achieng; Mendoza, Yolanda Guerra; Cherop, Reuben Yego; Okoth, George Odhiambo; Cravcenco, Cristina; Chipatala, Raphael; Roman, François; Oneko, Martina; Savic, Miloje; RTS,S Epidemiology EPI-MAL-003 Study Group |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2026 |
| Collection: |
London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| Description: |
BACKGROUND: RTS,S/AS01E 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/AS01E 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/AS01E 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/AS01E 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 |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
2214-109X |
| Relation: |
https://researchonline.lshtm.ac.uk/id/eprint/4678458/1/Ndeketa-etal-2025-Effectiveness-of-the-RTS.pdf; Ndeketa, Latif; Haine, Valérie; Debois, Muriel; Asante, Kwaku Poku ; Agyapong, Prince Darko; Kaali, Seyram; Devadiga, Raghavendra; Harrison, Samuel BE; Boahen, Owusu; French, Neil; +42 more.Kayan, Kingsley; Ogutu, Bernhards; Adeniji, Elisha; Kariuki, Simon; Owusu-Agyei, Seth ; Olewe, Fredrick; Jere, Tikhala Makhaza; Maleta, Kenneth; Mategula, Donnie; Mzanga, Phylis; Phiri, Vincent Katunga; Ansah, Patrick Odum; Orimbo, John; Ansah, Nana Akosua; Orsini, Mattea; Ong'echa, John Michael; Oduro, Abraham Rexford; Sifuna, Peter M; Azongo, Daniel K; Otieno, Walter; Bangre, Oscar; Kaburise, Michael Bandasua; Ababio, Lucy Osei; Oyieko, Janet Nyawira; Sing'oei, Valentine; Amoit, Stellah Kevyne; Nyangulu, Wongani; Schuerman, Lode; Awuni, Denis; Ochieng, Benard Omondi; Onyango, Irene; Odera-Ojwang, Patricia; Oguk, Esther Achieng; Mendoza, Yolanda Guerra; Cherop, Reuben Yego; Okoth, George Odhiambo; Cravcenco, Cristina; Chipatala, Raphael; Roman, François; Oneko, Martina; Savic, Miloje; and RTS,S Epidemiology EPI-MAL-003 Study Group (2026) 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. The Lancet. Global health, 14 (1). e61-e69. ISSN 2214-109X DOI:10.1016/S2214-109X(25)00415-2 |
| DOI: |
10.1016/s2214-109x(25)00415-2 |
| Availability: |
https://researchonline.lshtm.ac.uk/id/eprint/4678458/; https://doi.org/10.1016/s2214-109x(25)00415-2 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.F8DC4FF0 |
| Database: |
BASE |