Trial reportThe Journal of infectious diseases2020
A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults.
Trial report in The Journal of infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03162614 (Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 28 papers.
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, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Various Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
Who cites it
28 citing papers in PubMed, 45 citations in OpenAlex.
- Efficacy of RTS,S/AS01E Only Seen in Baseline Parasitemic and Not Baseline Aparasitemic Plasmodium falciparum-Exposed, Drug-Treated Kenyan Adults.The Journal of infectious diseases · 2025Trial
- Identification of RTS,S/AS01 vaccine-induced humoral biomarkers predictive of protection against controlled human malaria infection.JCI insight · 2024Trial
- Could Less Be More? Accounting for Fractional-Dose Regimens and Different Number of Vaccine Doses When Measuring the Impact of the RTS,S/AS01E Malaria Vaccine.The Journal of infectious diseases · 2024Trial
- A Pfs48/45-based vaccine to block Plasmodium falciparum transmission: phase 1, open-label, clinical trial.BMC medicine · 2024Trial
- Vaccination induces HIV broadly neutralizing antibody precursors in humans.Science (New York, N.Y.) · 2022Trial
- The Anti-Circumsporozoite Antibody Response of Children to Seasonal Vaccination With the RTS,S/AS01E Malaria Vaccine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Efficacy of RTS,S/AS01The Lancet. Infectious diseases · 2022Trial
- A modular nanoparticle display strategy for varicella-zoster virus gE based on a licensed protein scaffold.PLoS pathogens · 2026Article
- An Ethical Analysis of Public Attitudes towards Controlled Human Infection Studies in Singapore: Acceptability and Payment.Asian bioethics review · 2026Article
- Comparison of major, minor and junctional circumsporozoite protein epitopes for malaria vaccine design.NPJ vaccines · 2025Article
- Recombinant Full-length Plasmodium falciparum Circumsporozoite Protein-Based Vaccine Adjuvanted With Glucopyranosyl Lipid A-Liposome Quillaja saponaria 21: Results of Phase 1 Testing With Malaria Challenge.The Journal of infectious diseases · 2024Article
- Establishing RTS,S/AS01 as a benchmark for comparison to next-generation malaria vaccines in a mouse model.NPJ vaccines · 2024Article
- Controlled Human Malaria Infection Studies in Africa-Past, Present, and Future.Current topics in microbiology and immunology · 2024Review
- Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Review
- Protective antibody threshold of RTS,S/AS01 malaria vaccine correlates antigen and adjuvant dose in mouse model.NPJ vaccines · 2023Article
- Adjuvants for COVID-19 Vaccines.Vaccines · 2023Review
- A Review of Major Patents on Potential Malaria Vaccine Targets.Pathogens (Basel, Switzerland) · 2023Review
- Delayed boosting improves human antigen-specific Ig and B cell responses to the RH5.1/AS01B malaria vaccine.JCI insight · 2023Article
- Induction of antigen specific intrahepatic CD8+ T cell responses by a secreted heat shock protein based gp96-Ig-PfCA malaria vaccine.Frontiers in immunology · 2023Article
- 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
Corrections and comments
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Authors and funding
19 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA previous RTS,S/AS01B vaccine challenge trial demonstrated that a 3-dose (0-1-7-month) regimen with a fractional third dose can produce high vaccine efficacy (VE) in adults challenged 3 weeks after vaccination. This study explored the VE of different delayed fractional dose regimens of adult and pediatric RTS,S/AS01 formulations.
methodsA total of 130 participants were randomized into 5 groups. Four groups received 3 doses of RTS,S/AS01B or RTS,S/AS01E on a 0-1-7-month schedule, with the final 1 or 2 doses being fractional (one-fifth dose volume). One group received 1 full (month 0) and 1 fractional (month 7) dose of RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum-infected mosquito challenge (controlled human malaria infection) 3 months after immunization, a timing chosen to potentially discriminate VEs between groups.
resultsThe VE of 3-dose formulations ranged from 55% (95% confidence interval, 27%-72%) to 76% (48%-89%). Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE. The 2-dose group demonstrated lower VE (29% [95% confidence interval, 6%-46%]). All regimens were well tolerated and immunogenic, with trends toward higher anti-circumsporozoite antibody titers in participants protected against infection.
conclusionsRTS,S/AS01E can provide VE comparable to an equivalent RTS,S/AS01B regimen in adults, suggesting a universal formulation may be considered. Results also suggest that the 2-dose regimen is inferior to the 3-dose regimens evaluated. CLINICAL
trial registrationNCT03162614.
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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.