Seasonal R21 Mass Vaccination for Malaria Elimination
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16,200
- 试验地点
- 3
- 主要终点
- Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.
研究概览
简要总结
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.
The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses).
Secondary objectives are:
- To assess the safety and tolerability of R21 through spontaneously reported adverse events.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses).
- To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21.
- To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21.
- To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21.
- To determine the coverage of seasonal mass vaccination with R21 (primary series of three vaccinations and booster) in intervention clusters and related socio-cultural factors
- To estimate the cost of seasonal mass vaccination with R21 administration.
- To estimate the cost-effectiveness of seasonal mass vaccination with R21 compared to standard malaria control measures.
The exploratory objective is to determine whether serological markers can detect changes in malaria transmission following mass vaccination with R21.
详细描述
This is a cluster-randomized controlled trial. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination. Therefore,15 medium-sized (200-600 people) villages in The Gambia and 12 medium-sized (200-600 people) villages in Burkina Faso will receive the intervention. All study villages will receive standard control intervention, e.g., seasonal malaria chemoprevention, insecticide-treated bed nets, implemented by the National Malaria Control Program and according the National Strategic Plan for malaria control. Mass vaccination will be completed before the start of the malaria transmission season, i.e. July.
A cross-sectional survey to estimate malaria prevalence will be implemented at peak transmission, both following the mass vaccination with 3 doses (first year) and the booster dose (second year). A blood sample will be collected during the malaria transmission season from a cohort of randomly selected individuals to determine the incidence of malaria infection. A system of passive case detection to determine the incidence of clinical malaria will be set up throughout the study period, with special attention to the malaria transmission season (July-December).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age≥ 5 months.
- •Willingness to comply with trial procedures.
- •Individual written informed consent obtained at the beginning of the study.
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
- •Any history of anaphylaxis in relation to vaccination.
- •Known chronic illness.
- •Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
结局指标
主要结局
Prevalence of malaria infection by PCR in all age groups at peak transmission season (October-November) following the first vaccination with 3 doses.
时间窗: At 6 months ( October - November 2024) post first round of vaccination
A cross-sectional survey will be conducted at peak transmission in October -November 2024 to determine prevalence of malaria infection.
次要结局
- Occurrence of Adverse Events (AEs) during follow up.(Up to 28 days post vaccination)
- Incidence of malaria infection in all age groups during the transmission season following mass vaccination with R21(Up to 6 months post the third vaccination round)
- Incidence of clinical malaria in all age groups following mass vaccination with R21.(Up to 6 months post the third vaccination round)
- Prevalence of malaria infection by PCR in all age groups at peak transmission following the booster dose.(At 6 months ( October - November 2025) post booster dose)
- Coverage of completed vaccination schedule (3 doses) during the mass vaccination with 3 doses.(Up to 4 weeks post the third vaccination round)
- Cost of vaccine administration and cost effectiveness, both for the mass vaccination campaign with 3 doses and the booster dose.(Up to 6 months post booster dose)
- Incidence of malaria infection in all age groups during the transmission season following the booster dose.(Up to 6 months post booster dose)
- Incidence of clinical malaria in all age groups following the booster dose.(Up to 6 months post the third vaccination round)
- Coverage of at least one vaccine dose administered during the mass vaccination with 3 doses(Up to 4 weeks post the third vaccination round)
- Coverage of the booster dose(Up to 4 weeks post booster dose)