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A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants

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The RTS,S Clinical Trials Partnership·2012·New England Journal of Medicine

DOI 10.1056/nejmoa1208394PMC PMC10915853

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Abstract

BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.).

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Authors: The RTS, S. C. T. P.
Affiliations: Program for Appropriate Technology in Health (US)
Corresponding author: The RTS,S Clinical Trials Partnership
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-12-13
Volume: 367
Issue: 24
Pages: 2284-2295
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1208394
PMC: PMC10915853
OpenAlex: W2244674613
Cited by: 752
References: 31
Citations by year: 2026: 18 · 2025: 29 · 2024: 35 · 2023: 38 · 2022: 36 · 2021: 42 · 2020: 45 · 2019: 47 · 2018: 40 · 2017: 58 · 2016: 67 · 2015: 74 · 2014: 111 · 2013: 103 · 2012: 7
FWCI: 91.09
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: other-oa
Locations: New England Journal of Medicine (publishedVersion, other-oa)
PubMed (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
IHI Repository (acceptedVersion)
PubMed Central (acceptedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Funders: Bill and Melinda Gates Foundation
GlaxoSmithKline
Wellcome Trust (092654)
National Institutes of Health (CC999999)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Travel-related health issues
Keywords: RTS,S/AS01, malaria vaccine, infants, vaccine efficacy, clinical malaria, severe malaria, circumsporozoite protein, co-administration, immunogenicity, vaccine safety, Plasmodium falciparum, African infants, malaria prevention, vaccine adverse events
MeSH terms: Africa, Female, Humans, Immunization Schedule, Infant, Male, Plasmodium falciparum, Vaccines, Synthetic, Incidence, Proportional Hazards Models, Malaria, Falciparum, Treatment Outcome, Malaria Vaccines, Intention to Treat Analysis

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A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants

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