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A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants
Open accessAbstract
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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“There is only one malaria vaccine candidate that has received a positive regulatory assessment: RTS,S/AS01 (RTS,S) (Mosquirix), which is an injectable vaccine that provides partial protection against malaria in young children 115 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
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“The antigen is formulated as virus-like particle and combined with a liposomal adjuvant system.”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
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“In July 2015, European regulators approved the use of the vaccine, although it is at most 50% effective 115 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
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Cites
Modeling Survival Data: Extending the Cox Model
Therneau, T. M., & Grambsch, P. M. (2000) · Statistics for Biology and Health · doi:10.1007/978-1-4757-3294-8 · Cited by 8,674
Pushko, P., Pumpens, P., & Grens, E. (2013) · Intervirology · doi:10.1159/000346773 · Cited by 5,975
First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
The RTS, S. C. T. P. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1102287 · Cited by 896
Self-citationICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice.
Bhuiyan, P. S., & Rege, N. N. (2001) · PubMed · Cited by 527
Kester, K. E., Cummings, J. F., Ofori‐Anyinam, O., Ockenhouse, C. F., Krzych, U., Moris, P., Schwenk, R., Nielsen, R. A., Debebe, Z., Pinelis, E., et al. (2009) · The Journal of Infectious Diseases · doi:10.1086/600120 · Cited by 524
Siegrist, C. (2003) · Vaccine · doi:10.1016/s0264-410x(03)00342-6 · Cited by 350
Design and Analysis of Vaccine Studies
Halloran, M. E., Longini, I. M., & Struchiner, C. J. (2009) · Statistics for biology and health · doi:10.1007/978-0-387-68636-3 · Cited by 332
Aponte, J. J., Aide, P., Renom, M., Mandomando, I., Bassat, Q., Sacarlal, J., Manaca, M. N., Lafuente, S., Barbosa, A., Leach, A., et al. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61542-6 · Cited by 279
Glycoconjugate vaccines and immune interference: A review
Dagan, R., POOLMAN, J. T., & Siegrist, C. (2010) · Vaccine · doi:10.1016/j.vaccine.2010.06.026 · Cited by 270
Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants
Abdulla, S., Oberholzer, R., Juma, O. A., Kubhoja, S. D., Machera, F., Membi, C. D., Omari, S., Urassa, A., Mshinda, H., Jumanne, A., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0807773 · Cited by 239
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Laurens, M. B., & Plowe, C. V. (2022) · Springer eBooks · doi:10.1007/978-1-4939-2493-6_536-3
Lang, T. A. (2022) · Research Square · doi:10.21203/rs.3.rs-1145790/v1
Datta, S. (2021) · doi:10.33774/chemrxiv-2021-l393t-v36
Sorvillo, F. J., Shafir, S., & Bristow, B. N. (2015) · doi:10.1093/med/9780199661756.003.0215
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Menéndez, C., Bardají, A., & González, R. (2015) · Springer eBooks · doi:10.1007/978-1-4614-8326-7_61
Horii, T., & Palacpac, N. (2019) · Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature · doi:10.3410/f.735603359.793560046
Dobaño, C., Jairoce, C., Macià, D., Torres-Yaguana, J. P., Mayer, L., Vidal, M., Santano, R., Hurtado‐Guerrero, R., Reiter, K., Narum, D. L., et al. (2023) · Research Square · doi:10.21203/rs.3.rs-2352899/v1
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Liu, Y., Zhang, Y., Liang, L., Zhang, H., Zhang, T., Rong, X., Tan, J., & Mi, Y. (2026) · Frontiers in Microbiology · doi:10.3389/fmicb.2026.1795711
Dalsuco, J., Bassat, Q., Ahmed, H., Pfeffer, S., Winnips, C., Boulton, C., Otsyula, N., & D’Alessandro, U. (2026) · Tropical Medicine and Health · doi:10.1186/s41182-026-00935-5
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Oboge, H., Huang, W., Aboge, G., Chege, H. W., Ojuok, R., Chege, N., Musando, J., Poole, E. J., Thumbi, S. M., Nene, V. M., et al. (2026) · Vaccines · doi:10.3390/vaccines14050459
der Most, R. G. V., & Leroux-Roels, G. G. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1800411
Scaria, P. V., Chen, B., Muratova, O. V., Kemanli, P., Doritchamou, J., Lambert, L., Barnafo, E. K., Rausch, K. M., Narum, D. L., Shaligram, U. S., et al. (2026) · Vaccine · doi:10.1016/j.vaccine.2026.128913
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Orfano, A. S., Cisse, A., Guo, Y., Han, L., Fikadu, N., Thiam, L. G., Ba, A., Li, R., Pouye, M. N., Mangou, K., et al. (2026) · medRxiv · doi:10.64898/2026.08.25.26361130
Bashlakova, E., Zarro, M., Villari, P., Vito, C. D., & Rosso, A. (2026) · Journal of Infection and Public Health · doi:10.1016/j.jiph.2026.103356
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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
- 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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