NCT01373879已完成1 期
Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults and Children in a Malaria Endemic Area
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
研究概览
简要总结
The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 50 Years（Child, 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 and healthy children aged 2-6 years.with consenting parents.
排除标准
- •Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- •Severe malnutrition.
- •Hypersensitivity to HDCRV.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- •History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator
- •Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
- •Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
- •Blood transfusion within one month of enrolment.
- •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.
- •Positive malaria antigen test
结局指标
主要结局
Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
时间窗: Participants will be followed for the duration of the study, an expected average of 12 months
To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events
次要结局
- Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP(Participants will be followed for the duration of the study, an expected average of 12 months)
研究者
研究点 (1)
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