Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
研究概览
简要总结
The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.
The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Consenting adult males aged 18-50 years in good health.
- •Will remain resident in the study area for the study duration
排除标准
- •Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- •History of splenectomy
- •Haemoglobin less than 9.0 g/dl
- •Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
- •Blood transfusion within one month of the beginning of the study
- •History of vaccination with previous experimental malaria vaccines
- •Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
- •Current participation in another clinical trial, or within 12 weeks of this study
- •Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
- •Likelihood of travel away from the study area
- •HIV positive.
- •History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)
结局指标
主要结局
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
时间窗: Participants will be followed for the duration of the study, an expected average of 12 months
To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events
次要结局
- Immunogenicity of vaccines(Participants will be followed for the duration of the study, an expected average of 12 months)
- Immunogenicity of Vaccines(Participants will be followed for the duration of the study, an expected average of 12 months)