Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
研究概览
简要总结
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •resident in or near Lausanne;
- •age >18 and <45 years;
- •written informed consent;
- •>10/12 correct responses to the questionnaire of understanding.
排除标准
- •history of malaria; possible exposure to malaria within the previous 6 months;
- •positive serology for PfCS102by ELISA;
- •history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
- •pregnant or lactating female;
- •any confirmed or suspected immunodeficient condition;
- •seropostivity for HIV;
- •chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease;
- •hemoglobinopathies;
- •history of >2 hospitalisations for invasive bacterial infections;
- •requirement of any chronic medication;
- •suspected or known current alcohol or illegal drug abuse (excluding cannabis);
- •any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study;
- •a body mass index < 18kg/m2 or > 32 kg/m2;
- •evidence of past or present psychiatric condition;
- •seropositivity for HIV, hepatitis C or B (other than HBs Ab);
- •10-year risk of coronary heart disease <10%;
- •any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
研究组 & 干预措施
vaccine
30 µg of PfCS102 formulated in Montanide ISA 720
干预措施: PfCS102 (Biological)
adjuvant
Montanide ISA 720
干预措施: Montanide ISA 720 (Biological)
结局指标
主要结局
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy
时间窗: 1month
次要结局
- Incidence of adverse events(15 days)