Evidence map›Paper›PMID 38438123›Full record

Trial reportThe Journal of infectious diseases2024

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.

Nelli Westercamp, Lawrence Osei-Tutu, Lode Schuerman, Simon K Kariuki, Anne Bollaerts, Cynthia K Lee, Aaron M Samuels, Christian Ockenhouse, Dennis K Bii, Samuel Adjei and 14 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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03276962 (Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03276962 phase2completednot on this map

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2022Enrolled1,500ConditionsMalariaArmsRTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), Rabies vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Sustained efficacy of the RTS,S/AS01The Lancet. Global health · 2025
    Trial
  2. Advances in population-based interventions to control falciparum malaria.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2025
    Review
  3. 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

24 authors.

Nelli WestercampMalaria Branch, Division of Parasitic Diseases and Malaria, Global Health Center, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.ORCID 0000-0003-0136-9750
Lawrence Osei-TutuKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, Asante Akyem, Ghana.
Lode SchuermanGSK, Wavre, Belgium.
Simon K KariukiCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Anne BollaertsGSK, Wavre, Belgium.
Cynthia K LeeCenter for Vaccine Innovation and Access, PATH's Malaria Vaccine Initiative, Washington, DC, USA.
Aaron M SamuelsMalaria Branch, Division of Parasitic Diseases and Malaria, Global Health Center, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Christian OckenhouseCenter for Vaccine Innovation and Access, PATH's Malaria Vaccine Initiative, Washington, DC, USA.
Dennis K BiiCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Samuel AdjeiKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, 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, Asante Akyem, Ghana.
Cecilia AtienoCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Ashura BakariKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, Asante Akyem, Ghana.
Tony SangCentre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.
Maame Fremah Kotoh-MorttyKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, 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, Asante Akyem, Ghana.
Yaw NtiamoahKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, Asante Akyem, Ghana.
Daniel AnsongKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, Asante Akyem, Ghana.
Tsiri AgbenyegaKwame Nkrumah University of Science and Technology, Agogo Presbyterian Hospital, Asante Akyem, Ghana.
Opokua Ofori-AnyinamGSK, Wavre, Belgium.

Funding

Federal Ministry of Education and ResearchGlaxoSmithKlinePATH
6 · The paper itself

Abstract

backgroundThe RTS,S/AS01E (RTS,S) malaria vaccine is recommended for children in malaria endemic areas. This phase 2b trial evaluates RTS,S fractional- and full-dose regimens in Ghana and Kenya.

methodsIn total, 1500 children aged 5-17 months were randomized (1:1:1:1:1) to receive RTS,S or rabies control vaccine. RTS,S groups received 2 full RTS,S doses at months 0 and 1 and either full (groups R012-20, R012-14-26) or fractional doses (one-fifth; groups Fx012-14-26, Fx017-20-32).

resultsAt month 32 post-dose 1, vaccine efficacy against clinical malaria (all episodes) ranged from 38% (R012-20; 95% confidence interval [CI]: 24%-49%) to 53% (R012-14-26; 95% CI: 42%-62%). Vaccine impact (cumulative number of cases averted/1000 children vaccinated) was 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), and 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional vs full dose; post hoc analysis), we estimated cases averted/1000 RTS,S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), and 880 (Fx017-20-32).

conclusionsVaccine efficacy was similar across RTS,S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. If maintained through trial end, these observations underscore the means to reduce cost per regimen thus maximizing impact and optimizing supply. CLINICAL TRIALS REGISTRATION: NCT03276962 (ClinicalTrials.gov).

Indexed as

Malaria, FalciparumMalaria VaccinesVaccine EfficacyFemaleGhanaHumansImmunization ScheduleInfantKenyaMalariaMalePlasmodium falciparumMalaria VaccinesRTS,S-AS01E vaccinefractional-dose regimenmalaria vaccineRTS, S/AS01Evaccine efficacyvaccine impact

Identifiers

PMID38438123
PMCPMC11326831

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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.