Evidence map›Paper›PMID 41024138›Full record

ArticleTrials2025

Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial.

Edgard D Dabira, H Magloire Natama, Fatou Jaiteh, Koen Peeters Grietens, Fadima Y Bocoum, Mamadou Ousmane Ndiath, Nuredin Mohammed, Balla Gibba, Adrian V S Hill, Azra Ghani and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06578572 (Seasonal R21 Mass Vaccination for Malaria Elimination), 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.

NCT06578572 phase3recruitingnot on this map

Seasonal R21 Mass Vaccination for Malaria Elimination

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2024 to 2025Enrolled16,200ConditionsMalariaArmsR21Matrix M
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

13 authors.

Edgard D DabiraDisease Control & Elimination Theme, Medical Research Council The Gambia Unit at London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Fajara, The Gambia. Edgard.Dabira@lshtm.ac.uk.
H Magloire NatamaUnité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de La Santé- Direction Régionale du Centre Ouest (URCN/IRSS-DRCO), Nanoro, Burkina Faso.
Fatou JaitehDepartment of Public Health, Institute of Tropical Medicine, Socio-Ecological Health Research Unit, Antwerp, Belgium.
Koen Peeters GrietensDepartment of Public Health, Institute of Tropical Medicine, Socio-Ecological Health Research Unit, Antwerp, Belgium.
Fadima Y BocoumInstitut de Recherche en Sciences de La Santé (IRSS), Ouagadougou, Burkina Faso.
Mamadou Ousmane NdiathDisease Control & Elimination Theme, Medical Research Council The Gambia Unit at London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Fajara, The Gambia.
Nuredin MohammedDisease Control & Elimination Theme, Medical Research Council The Gambia Unit at London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Fajara, The Gambia.
Balla GibbaNational Malaria Control Programme, Banjul, The Gambia.
Adrian V S HillCentre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, University of Oxford, Oxford, UK.
Azra GhaniMRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, UK.
Annette ErhartDisease Control & Elimination Theme, Medical Research Council The Gambia Unit at London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Fajara, The Gambia.
Halidou TintoUnité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de La Santé- Direction Régionale du Centre Ouest (URCN/IRSS-DRCO), Nanoro, Burkina Faso.
Umberto D'AlessandroDisease Control & Elimination Theme, Medical Research Council The Gambia Unit at London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Fajara, The Gambia.

Funding

UK Research and Innovation MR/Y00468X/1
6 · The paper itself

Abstract

introductionProgress in malaria control has stalled since 2015, highlighting the need for new control tools. The R21/Matrix-M (R21) malaria vaccine, a pre-erythrocytic vaccine recently approved by WHO for small children, may be one of these tools. This trial aims to assess whether seasonal mass vaccination with R21 reduces malaria transmission in The Gambia and Burkina Faso, two countries at the extreme of the transmission spectrum.

methodsThis is a multi-centre open cluster-randomised controlled trial to assess the impact of mass vaccination with R21 on malaria transmission and morbidity. The trial will be implemented in eastern Gambia (low to moderate transmission) and Central Burkina Faso (intense transmission). Thirty medium-sized villages in The Gambia and 24 in Burkina Faso will be randomised (1:1) to either intervention or control arm. All eligible residents in intervention villages will receive R21 vaccinations in three-monthly rounds, from May to July 2024, prior to the malaria transmission season. A booster vaccine dose will be administered the following year, in June 2025. The primary outcome is malaria prevalence at peak transmission (November 2024). Secondary outcomes include safety and tolerability, incidence of clinical malaria, vaccination coverage and community acceptability, cost and cost-effectiveness of the intervention. DISCUSSION: This is the first trial on seasonal mass vaccination aiming at reducing malaria transmission. Strengths of the study include its design as an adequately powered cluster-randomised trial and the inclusion of study sites with differing transmission intensity which will also provide safety and efficacy data for different age groups. Key challenges remain vaccine hesitancy and vaccination coverage. If successful, R21 seasonal mass vaccination will be an innovative intervention to accelerate malaria elimination efforts and reach the goal set in the Global Technical Strategy for malaria 2016-2030.

trial registrationClinical trials.gov, NCT06578572. Registered on 27 March 2024.

Indexed as

MalariaMalaria VaccinesMass VaccinationBurkina FasoChild, PreschoolGambiaHumansInfantMulticenter Studies as TopicRandomized Controlled Trials as TopicSeasonsMalaria VaccinesBurkina FasoCluster randomised trialMalariaR21/Matrix-MSeasonal mass vaccinationThe Gambia

Identifiers

PMID41024138
PMCPMC12481873

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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.