Evidence map›Paper›PMID 35753316›Full record

Trial reportThe Lancet. Infectious diseases2022

Efficacy of RTS,S/AS01

Aaron M Samuels, Daniel Ansong, Simon K Kariuki, Samuel Adjei, Anne Bollaerts, Christian Ockenhouse, Nelli Westercamp, Cynthia K Lee, Lode Schuerman, Dennis K Bii and 17 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Lancet. Infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
13.2field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
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  5. Sustained efficacy of the RTS,S/AS01The Lancet. Global health · 2025
    Trial
  6. Genotypic analysis of RTS,S/AS01The Lancet. Infectious diseases · 2024
    Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 6 institutions in 4 countries.

Aaron M SamuelsMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, United States Centers for Disease Control and Prevention, Kisumu, Kenya; Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: amsamuels@cdc.gov.
Daniel AnsongKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Simon K KariukiCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Samuel AdjeiKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Anne BollaertsGSK, Wavre, Belgium.
Christian OckenhousePATH's Malaria Vaccine Initiative, Washington, DC, USA.
Nelli WestercampMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Cynthia K LeePATH's Malaria Vaccine Initiative, Washington, DC, USA.
Lode SchuermanGSK, Wavre, Belgium.
Dennis K BiiCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Lawrence Osei-TutuKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Martina OnekoCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Marc LievensGSK, Wavre, Belgium.
Maame Anima Attobrah SarfoKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Cecilia AtienoCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Danielle MorelleGSK, Wavre, Belgium.
Ashura BakariKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Tony SangCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Erik JongertGSK, Wavre, Belgium.
Maame Fremah Kotoh-MorttyKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Kephas OtienoCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
François RomanGSK, Wavre, Belgium.
Patrick Boakye Yiadom BuabengKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Yaw NtiamoahKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
Opokua Ofori-AnyinamGSK, Wavre, Belgium.
Tsiri AgbenyegaKwame Nkrumah University of Science and Technology/Agogo Presbyterian Hospital, Agogo, Asante Akyem, Ghana.
RTS,S study group
GlaxoSmithKline (Belgium) · BEKenya Medical Research Institute · KEKwame Nkrumah University of Science and Technology · GHPresbyterian University, Ghana · GHCenter for Global Health · USU.S. President's Malaria Initiative · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundControlled infection studies in malaria-naive adults suggest increased vaccine efficacy for fractional-dose versus full-dose regimens of RTS,S/AS01. We report first results of an ongoing trial assessing different fractional-dose regimens in children, in natural exposure settings.

methodsThis open-label, phase 2b, randomised controlled trial is conducted at the Malaria Research Center, Agogo, Ashanti Region (Ghana), and the Kenya Medical Research Institute and the US Centers for Disease Control and Prevention site in Siaya County (Kenya). We enrolled children aged 5-17 months without serious acute or chronic illness who had previously received three doses of diphtheria, tetanus, pertussis, and hepatitis B vaccine and at least three doses of oral polio vaccine. Children were randomly assigned (1:1:1:1:1) using a web-based randomisation system with a minimisation procedure accounting for centre to receive rabies control vaccine (M012 schedule) or two full doses of RTS,S/AS01

findingsBetween Sept 28, 2017, and Sept 25, 2018, 2157 children were enrolled, of whom 1609 were randomly assigned to a treatment group (322 to each RTS,S/AS01

interpretationThe Fx012-14 regimen was not superior to the standard regimen over 12 months after dose three. All RTS,S/AS01

fundingGlaxoSmithKline Biologicals; PATH's Malaria Vaccine Initiative.

Indexed as

MalariaMalaria, FalciparumMalaria VaccinesRabies VaccinesAdultChildGhanaHumansKenyaMalaria VaccinesRabies Vaccines

Identifiers

PMID35753316
PMCPMC9420828
OpenAlexW4283399455

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.