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, Annette Erhart, Halidou Tinto, Umberto D'Alessandro
{"title":"季节性大规模接种R21/Matrix-M以消除疟疾（SERVAL）：聚类随机试验方案。","authors":"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, Annette Erhart, Halidou Tinto, Umberto D'Alessandro","doi":"10.1186/s13063-025-09048-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Progress 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.</p><p><strong>Methods: </strong>This 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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>Clinical trials.gov, NCT06578572. Registered on 27 March 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"382"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481873/pdf/","citationCount":"0","resultStr":"{\"title\":\"Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial.\",\"authors\":\"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, Annette Erhart, Halidou Tinto, Umberto D'Alessandro\",\"doi\":\"10.1186/s13063-025-09048-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Progress 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.</p><p><strong>Methods: </strong>This 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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>Clinical trials.gov, NCT06578572. 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Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised trial.
Introduction: Progress 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.
Methods: This 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 registration: Clinical trials.gov, NCT06578572. Registered on 27 March 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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