Trial reportPloS one2009
Insights into long-lasting protection induced by RTS,S/AS02A malaria vaccine: further results from a phase IIb trial in Mozambican children.
Trial report in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00197041 (A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, Administered Intramuscularly According to a 0, 1 and 2 Month Vaccination Schedule in Toddlers and Children Aged 1 to 4 Years in a Malaria-endemic Region of Mozambique.), which is not on this map. Cited by 46 papers, 2 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 to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, Administered Intramuscularly According to a 0, 1 and 2 Month Vaccination Schedule in Toddlers and Children Aged 1 to 4 Years in a Malaria-endemic Region of Mozambique.
Who cites it
46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 96 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
- Pooled it
- 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
- Evaluating artesunate monotherapy and dihydroartemisinin-piperaquine as potential antimalarial options for prevaccination radical cures during future malaria vaccine field efficacy trials.Malaria journal · 2024Trial
- Trial
- Concentration and avidity of antibodies to different circumsporozoite epitopes correlate with RTS,S/AS01E malaria vaccine efficacy.Nature communications · 2019Trial
- Differential Patterns of IgG Subclass Responses toFrontiers in immunology · 2019Trial
- RTS,S vaccination is associated with serologic evidence of decreased exposure to Plasmodium falciparum liver- and blood-stage parasites.Molecular & cellular proteomics : MCP · 2015Trial
- Trial
- Phase 1b randomized trial and follow-up study in Uganda of the blood-stage malaria vaccine candidate BK-SE36.PloS one · 2013Trial
- Effect of the pre-erythrocytic candidate malaria vaccine RTS,S/AS01E on blood stage immunity in young children.The Journal of infectious diseases · 2011Trial
- Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial.The Lancet. Infectious diseases · 2011Trial
- Trial
- Trial
- Role of malaria exposure and off-target responses on RTS,S/AS02NPJ vaccines · 2025Article
- Measuring protective efficacy and quantifying the impact of drug resistance: A novel malaria chemoprevention trial design and methodology.PLoS medicine · 2024Article
- Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Review
- Malaria vaccines: the 60-year journey of hope and final success-lessons learned and future prospects.Tropical medicine and health · 2023Review
- Genetic diversity of Plasmodium falciparum AMA-1 antigen from the Northeast Indian state of Tripura and comparison with global sequences: implications for vaccine development.Malaria journal · 2022Article
- Strategic Variants of CSP Delivered as SynDNA Vaccines Demonstrate Heterogeneity of Immunogenicity and Protection fromInfection and immunity · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe pre-erythrocytic malaria vaccine RTS,S/AS02A has shown to confer protection against clinical malaria for at least 21 months in a trial in Mozambican children. Efficacy varied between different endpoints, such as parasitaemia or clinical malaria; however the underlying mechanisms that determine efficacy and its duration remain unknown. We performed a new, exploratory analysis to explore differences in the duration of protection among participants to better understand the protection afforded by RTS,S. METHODOLOGY/PRINCIPAL
findingsThe study was a Phase IIb double-blind, randomized controlled trial in 2022 children aged 1 to 4 years. The trial was designed with two cohorts to estimate vaccine efficacy against two different endpoints: clinical malaria (cohort 1) and infection (cohort 2). Participants were randomly allocated to receive three doses of RTS,S/AS02A or control vaccines. We did a retrospective, unplanned sub-analysis of cohort 2 data using information collected for safety through the health facility-based passive case detection system. Vaccine efficacy against clinical malaria was estimated over the first six-month surveillance period (double-blind phase) and over the following 12 months (single-blind phase), and analysis was per-protocol. Adjusted vaccine efficacy against first clinical malaria episodes in cohort 2 was of 35.4% (95% CI 4.5-56.3; p = 0.029) over the double-blind phase and of 9.0% (-30.6-36.6; p = 0.609) during the single-blind phase. CONCLUSIONS/SIGNIFICANCE: Contrary to observations in cohort 1, where efficacy against clinical malaria did not wane over time, in cohort 2 the efficacy decreases with time. We hypothesize that this reduced duration of protection is a result of the early diagnosis and treatment of infections in cohort 2 participants, preventing sufficient exposure to asexual-stage antigens. On the other hand, the long-term protection against clinical disease observed in cohort 1 may be a consequence of a prolonged exposure to low-dose blood-stage asexual parasitaemia.
trial registrationClinicalTrials.gov NCT00197041.
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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.