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

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2025-09-29 DOI:10.1186/s13063-025-09048-6

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

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引用次数: 0

Abstract

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.

查看原文本刊更多论文

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。

导言：自2015年以来，疟疾控制方面的进展停滞不前，这突出表明需要新的控制工具。R21/Matrix-M （R21）疟疾疫苗是世卫组织最近批准用于幼儿的红细胞前疫苗，可能是这些工具之一。该试验旨在评估季节性大规模接种R21疫苗是否能减少冈比亚和布基纳法索的疟疾传播，这两个国家处于传播谱的极端。方法：这是一项多中心开放集群随机对照试验，旨在评估大规模接种R21疫苗对疟疾传播和发病率的影响。该试验将在冈比亚东部（低至中等传播）和布基纳法索中部（高传播）实施。冈比亚的30个中等村庄和布基纳法索的24个中等村庄将被随机分配（1:1）到干预组或对照组。干预村所有符合条件的居民将在疟疾传播季节之前，从2024年5月至7月，分三轮接种R21疫苗。下一年，即2025年6月，将接种一剂加强疫苗。主要结果是疟疾传播高峰时的流行情况（2024年11月）。次要结局包括安全性和耐受性、临床疟疾发病率、疫苗接种覆盖率和社区可接受性、干预措施的成本和成本效益。讨论：这是旨在减少疟疾传播的季节性大规模疫苗接种的首次试验。该研究的优势包括其设计为一项充分有力的集群随机试验，并纳入了具有不同传播强度的研究地点，这也将为不同年龄组提供安全性和有效性数据。主要挑战仍然是疫苗犹豫和疫苗接种覆盖率。如果取得成功，R21季节性大规模疫苗接种将成为加速消除疟疾努力和实现《2016-2030年全球疟疾技术战略》所设定目标的一项创新干预措施。试验注册：Clinical trials.gov, NCT06578572。于2024年3月27日注册

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

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.