Phase 1 Dose Escalation Study of The Plasmodium Vivax Transmission-Blocking Vaccine Pvs230D1-EPA/Matrix-M to Assess Safety, Immunogenicity, and Transmission-Blocking Activity in Healthy Malaria-Naive Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults
研究概览
简要总结
Background:
Malaria is a disease carried by mosquitoes in tropical countries around the world. It can cause symptoms like fever, body aches, and weakness. More than half a million people worldwide died of malaria in 2021, mostly children. Researchers want to find ways to prevent the spread of this disease.
Objective:
To test the effects of a new malaria vaccine. (Volunteers will not be exposed to malaria.)
Eligibility:
Healthy adults aged 18 to 50 years.
Design:
Volunteers will be screened. They will have a physical exam with blood and urine tests. They will take a short quiz to make sure they understand the study.
Volunteers will have 3 visits to receive the vaccine. These visits will be about 1 month apart. The vaccine will be injected into the muscle of the upper arm.
Volunteers will have 12 additional clinic visits. These will start after the first vaccine visit and continue for 8 months. The visits may include a physical exam and blood tests. There will also be 7 follow-up phone calls. These will occur the day after each vaccine visit and then continue for another 12 months. Participants will be asked how they are doing and whether they have had any changes in their health.
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详细描述
Study Description:
Single-center, open-label, first-in-human, dose-escalating phase 1 study to characterize the safety, immunogenicity, and transmission-blocking activity in healthy malaria-naive adults of the Plasmodium vivax (P. vivax) transmission-blocking vaccine (TBV), Pvs230D1-EPA combined with adjuvant Matrix-M (MM). Three doses of vaccine will be administered at 1-month intervals (study days 0, 28, and 56). Subjects will be divided into low, intermediate, and high dose groups based on the amount of the antigen component in each vaccine dose:
- Group 1 (n = 10): 5 (micro)g Pvs230D1-EPA/50 (micro)g MM
- Group 2 (n = 10): 25 (micro)g Pvs230D1-EPA/50 (micro)g MM
- Group 3 (n = 10): 50 (micro)g Pvs230D1-EPA/50 (micro)g MM
Objectives:
Primary Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
5 (micro)g Pvs230D1-EPA/50 (micro)g MM
干预措施: Pvs230D1-EPA/Matrix-M (Drug)
Group 2
25 (micro)g Pvs230D1-EPA/50 (micro)g MM
干预措施: Pvs230D1-EPA/Matrix-M (Drug)
Group 3
50 (micro)g Pvs230D1-EPA/50 (micro)g MM
干预措施: Pvs230D1-EPA/Matrix-M (Drug)
结局指标
主要结局
To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults
时间窗: Receipt of first vaccine through subject study completion
Incidence and severity of local and systemic adverse events (AEs) or serious adverse events (SAEs)
次要结局
未报告次要终点