Evidence map›Paper›PMID 40439411›Full record

Trial reportThe Journal of infectious diseases2025

Efficacy of RTS,S/AS01E Only Seen in Baseline Parasitemic and Not Baseline Aparasitemic Plasmodium falciparum-Exposed, Drug-Treated Kenyan Adults.

Nathanial K Copeland, Lucas Otieno, June Doryne Otieno, Solomon Otieno, Salome Chira, Karen Ivinson, Irene Onyango, Ruth Wasuna, Hoseah Akala, Amos Onditi and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04661579 (A Phase 2b Randomized, Open-label, Controlled, Single Center Study in Plasmodium Falciparum-infected and Uninfected Adults Age 18-55 Years Old in Kenya to Evaluate the Efficacy of the Delayed, Fractional Dose RTS,S/AS01E Malaria Vaccine in Subjects Treated With Artemisinin Combination Therapy Plus Primaquine), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT04661579 phase2completednot on this map

A Phase 2b Randomized, Open-label, Controlled, Single Center Study in Plasmodium Falciparum-infected and Uninfected Adults Age 18-55 Years Old in Kenya to Evaluate the Efficacy of the Delayed, Fractional Dose RTS,S/AS01E Malaria Vaccine in Subjects Treated With Artemisinin Combination Therapy Plus Primaquine

TypeinterventionalSponsorPATHRan2020 to 2022Enrolled620ConditionsPlasmodium FalciparumArmsMalaria Vaccine RTS,S/AS01E, Abhayrab rabies vaccine, Dihydroartemisinin-piperaquine (DHA/Pip), Artemether / Lumefantrine, Primaquine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Nathanial K CopelandKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.ORCID 0000-0003-1504-253X
Lucas OtienoKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
June Doryne OtienoKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Solomon OtienoKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Salome ChiraCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.
Karen IvinsonCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.
Irene OnyangoKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Ruth WasunaKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Hoseah AkalaKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Amos OnditiKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Peter SifunaKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Ben AndagaluKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.ORCID 0000-0002-8678-7478
Roselyne OyugiKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Mary OmondiKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Stellah AmoitKombewa Clinical Research Centre, Kenya Medical Research Institute/US Army Medical Research Directorate-Africa, Kisumu, Kenya.
Emily LockeCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.ORCID 0000-0003-1944-8473
Scott GregoryCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.
Elke S Bergmann-LeitnerBiologics Research & Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.ORCID 0000-0002-8571-8956
Hema PindoliaHuman Immunology Laboratory, International AIDS Vaccine Initiative, London, United Kingdom.
Mike RaineCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.ORCID 0000-0001-8396-6748
Chris GastCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.ORCID 0000-0003-4216-679X
Laina D MercerCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.
John J AponteCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.ORCID 0000-0002-3014-3673
Marc LievensVaccine Clinical R&D, GlaxoSmithKline, Wavre, Belgium.
Christian F OckenhouseCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.
Cynthia K LeeCenter for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA; Seattle, Washington, USA; Nairobi, Kenya; and Geneva, Switzerland.

Funding

Bill and Melinda Gates Foundation INV-042281Gates Foundation INV-007217Gates Foundation INV-008924
6 · The paper itself

Abstract

backgroundRTS,S/AS01 vaccine efficacy (VE) was previously shown as lower in African adults than in malaria-naive US adults, potentially due to concurrent Plasmodium falciparum infections. We investigated whether treatment of infection prior to vaccination would lead to improved VE and immunogenicity.

methodsA phase 2b study in Kenyan adults evaluated the efficacy of RTS,S/AS01E in conjunction with antimalarial chemopreventive drugs. Participants, grouped by baseline presence or absence of P. falciparum infections, were randomized to receive RTS,S/AS01E or rabies vaccine. Four groups received antimalarial drugs prior to immunization and were followed for 6 months to assess P. falciparum infection. We included an additional group not treated with antimalarial drugs for immunological assessment.

resultsVE (RTS,S/AS01E vs rabies vaccine) was 34.8% (95% confidence interval [CI], 8.9% to 53.4%) and -24.0% (95% CI, -97% to 22.4%) in baseline P. falciparum-positive and P. falciparum-negative participants, respectively. In RTS,S/AS01E recipients, there were no statistical differences in anticircumsporozoite (anti-CS) antibody titers in baseline P. falciparum-positive or P. falciparum-negative participants, or in susceptibility to infection during the postvaccination follow-up period. Drug treatment did not improve anti-CS antibody titers.

conclusionsTreating P. falciparum infections during vaccination does not result in increased VE. Anti-CS antibody responses to vaccination do not differ with baseline P. falciparum infection status, drug treatment, or susceptibility to P. falciparum infections. CLINICAL TRIALS REGISTRATION: NCT04661579; PACTR202006896481432.

Indexed as

AntimalarialsMalaria, FalciparumMalaria VaccinesParasitemiaPlasmodium falciparumVaccine EfficacyAdolescentAdultAntibodies, ProtozoanFemaleHumansKenyaMaleMiddle AgedRabies VaccinesVaccines, SyntheticAntibodies, ProtozoanAntimalarialsMalaria VaccinesRabies VaccinesRTS,S-AS01 vaccineVaccines, Syntheticantimalarial drug treatment and malaria vaccineCSP antibody titers and infectionmalaria vaccine in African adultsRTS,S/AS01vaccine-induced antibodies and infection

Identifiers

PMID40439411
PMCPMC12455321

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.