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Cited by 755Malaria Research and ControlBacterial Infections and VaccinesTravel-related health issues

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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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  1. Brabin B, 1990, Trop Dis Bull, 87, R1

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Metadata

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
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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