Trial reportVaccine2020
Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa.
Trial report in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00866619 (Efficacy of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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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.
Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Unraveling the HIV-malaria interactions: a bibliometric analysis of global research trends and emerging insights.Frontiers in microbiology · 2025Pooled it
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults.The Journal of clinical investigation · 2024Trial
- Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines.Communications biology · 2020Trial
- Malaria Vaccines and Global Equity: A Scoping Review of Current Progress and Future Directions.Biomedicines · 2025Review
- Safety of RTS,S/AS01E vaccine for malaria in African children aged 5 to 17 months: A systematic review and meta-analysis of randomized controlled trials.PLOS global public health · 2025Article
- PfSPZ Vaccine induces focused humoral immune response in HIV positive and negative Tanzanian adults.EBioMedicine · 2024Article
- Malaria vaccine efficacy, safety, and community perception in Africa: a scoping review of recent empirical studies.Infection · 2024Article
- Policy uptake and implementation of the RTS,S/AS01 malaria vaccine in sub-Saharan African countries: status 2 years following the WHO recommendation.BMJ global health · 2024Review
- The Potential Role of Vaccines in Preventing Antimicrobial Resistance (AMR): An Update and Future Perspectives.Vaccines · 2023Review
- Systematic Review of Safety of RTS,S with AS01 and AS02 Adjuvant Systems Using Data from Randomized Controlled Trials in Infants, Children, and Adults.Clinical pharmacology : advances and applications · 2023Review
- RTS,S/AS01 malaria vaccine (MosquirixDrugs & therapy perspectives : for rational drug selection and use · 2022Review
- Modelling the global burden of drug-resistant tuberculosis avertable by a post-exposure vaccine.Nature communications · 2021Article
- Pre-Erythrocytic Vaccines against Malaria.Vaccines · 2020Review
- Antibody responses to the RTS,S/AS01NPJ vaccines · 2020Article
- Knowledge, acceptance and willingness to pay for malaria vaccine among residents of a semi-urban community in Kaduna State, North-western Nigeria.Nigerian medical journal : journal of the Nigeria Medical AssociationArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
37 authors at 13 institutions in 12 countries.
Funding
Abstract
backgroundWe assessed the safety and immunogenicity of the RTS,S/AS01 malaria vaccine in a subset of children identified as HIV-infected during a large phase III randomized controlled trial conducted in seven sub-Saharan African countries.
methodsInfants 6-12 weeks and children 5-17 months old were randomized to receive 4 RTS,S/AS01 doses (R3R group), 3 RTS,S/AS01 doses plus 1 comparator vaccine dose (R3C group), or 4 comparator vaccine doses (C3C group) at study months 0, 1, 2 and 20. Infants and children with WHO stage III/IV HIV disease were excluded but HIV testing was not routinely performed on all participants; our analyses included children identified as HIV-infected based on medical history or clinical suspicion and confirmed by polymerase chain reaction or antibody testing. Serious adverse events (SAEs) and anti-circumsporozoite (CS) antibodies were assessed.
resultsOf 15459 children enrolled in the trial, at least 1953 were tested for HIV and 153 were confirmed as HIV-infected (R3R: 51; R3C: 54; C3C: 48). Among these children, SAEs were reported for 92.2% (95% CI: 81.1-97.8) in the R3R, 85.2% (72.9-93.4) in the R3C and 87.5% (74.8-95.3) in the C3C group over a median follow-up of 39.3, 39.4 and 38.3 months, respectively. Fifteen HIV-infected participants in each group (R3R: 29.4%, R3C: 27.8%, C3C: 31.3%) died during the study. No deaths were considered vaccination-related. In a matched case-control analysis, 1 month post dose 3 anti-CS geometric mean antibody concentrations were 193.3 EU/mL in RTS,S/AS01-vaccinated HIV-infected children and 491.5 EU/mL in RTS,S/AS01-vaccinated immunogenicity controls with unknown or negative HIV status (p = 0.0001).
conclusionsThe safety profile of RTS,S/AS01 in HIV-infected children was comparable to that of the comparator (meningococcal or rabies) vaccines. RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status. CLINICAL
trial registrationClinicalTrials.gov: NCT00866619.
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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.