Trial reportThe New England journal of medicine2008
Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age.
Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 202 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya
Malaria Vaccine Phase IB Clinical Trial: Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants
Who cites it
202 citing papers in PubMed, 6 syntheses or guidelines pooled it, 412 citations in OpenAlex.
- A systematic review on malaria and dengue vaccines for the effective management of these mosquito borne diseases: Improving public health.Human vaccines & immunotherapeutics · 2024Pooled it
- Iron Deficiency Is Associated With Reduced Levels of Plasmodium falciparum-specific Antibodies in African Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Pooled it
- Peripheral blood monocyte-to-lymphocyte ratio at study enrollment predicts efficacy of the RTS,S malaria vaccine: analysis of pooled phase II clinical trial data.BMC medicine · 2013Pooled it
- Haemoglobinopathies and the clinical epidemiology of malaria: a systematic review and meta-analysis.The Lancet. Infectious diseases · 2012Pooled it
- Pooled it
- Pooled it
- A sustainable house design to improve child health in rural Africa: a cluster-randomized controlled trial.Nature medicine · 2026Trial
- Antibody fine specificity correlates with protection from malaria for the RTS,S vaccine in young African children: A post hoc analysis of a phase IIb randomised controlled trial.PLoS medicine · 2026Trial
- Induction, decay, and determinants of functional antibodies following vaccination with the RTS,S malaria vaccine in young children.BMC medicine · 2022Trial
- Trial
- Concentration and avidity of antibodies to different circumsporozoite epitopes correlate with RTS,S/AS01E malaria vaccine efficacy.Nature communications · 2019Trial
- Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa.Human vaccines & immunotherapeutics · 2019Trial
- Systems analysis of protective immune responses to RTS,S malaria vaccination in humans.Proceedings of the National Academy of Sciences of the United States of America · 2017Trial
- A monoclonal antibody-based immunoassay to measure the antibody response against the repeat region of the circumsporozoite protein of Plasmodium falciparum.Malaria journal · 2016Trial
- Seven-Year Efficacy of RTS,S/AS01 Malaria Vaccine among Young African Children.The New England journal of medicine · 2016Trial
- Trial
- Genetic Diversity and Protective Efficacy of the RTS,S/AS01 Malaria Vaccine.The New England journal of medicine · 2015Trial
- IFNγ Responses to Pre-erythrocytic and Blood-stage Malaria Antigens Exhibit Differential Associations With Past Exposure and Subsequent Protection.The Journal of infectious diseases · 2015Trial
- RTS,S vaccination is associated with serologic evidence of decreased exposure to Plasmodium falciparum liver- and blood-stage parasites.Molecular & cellular proteomics : MCP · 2015Trial
- Ad35.CS.01-RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naïve Adults.PloS one · 2015Trial
142 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
29 authors at 8 institutions in 7 countries.
Funding
Abstract
backgroundPlasmodium falciparum malaria is a pressing global health problem. A previous study of the malaria vaccine RTS,S (which targets the circumsporozoite protein), given with an adjuvant system (AS02A), showed a 30% rate of protection against clinical malaria in children 1 to 4 years of age. We evaluated the efficacy of RTS,S given with a more immunogenic adjuvant system (AS01E) in children 5 to 17 months of age, a target population for vaccine licensure.
methodsWe conducted a double-blind, randomized trial of RTS,S/AS01E vaccine as compared with rabies vaccine in children in Kilifi, Kenya, and Korogwe, Tanzania. The primary end point was fever with a falciparum parasitemia density of more than 2500 parasites per microliter, and the mean duration of follow-up was 7.9 months (range, 4.5 to 10.5).
resultsA total of 894 children were randomly assigned to receive the RTS,S/AS01E vaccine or the control (rabies) vaccine. Among the 809 children who completed the study procedures according to the protocol, the cumulative number in whom clinical malaria developed was 32 of 402 assigned to receive RTS,S/AS01E and 66 of 407 assigned to receive the rabies vaccine; the adjusted efficacy rate for RTS,S/AS01E was 53% (95% confidence interval [CI], 28 to 69; P<0.001) on the basis of Cox regression. Overall, there were 38 episodes of clinical malaria among recipients of RTS,S/AS01E, as compared with 86 episodes among recipients of the rabies vaccine, with an adjusted rate of efficacy against all malarial episodes of 56% (95% CI, 31 to 72; P<0.001). All 894 children were included in the intention-to-treat analysis, which showed an unadjusted efficacy rate of 49% (95% CI, 26 to 65; P<0.001). There were fewer serious adverse events among recipients of RTS,S/AS01E, and this reduction was not only due to a difference in the number of admissions directly attributable to malaria.
conclusionsRTS,S/AS01E shows promise as a candidate malaria vaccine. (ClinicalTrials.gov number, NCT00380393.)
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.