A Phase 1 Trial of the Malaria Candidate Vaccines FP9 CS and MVA CS in Adult Gambian Men Aged 18 - 45 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Safety and immunogenicity
研究概览
简要总结
Animal and human studies have shown that the prime-boost immunization strategy using malaria antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not provide significant clinical protection against infection. The investigators assessed two new vaccines which utilize a similar immunization strategy but a different malaria antigen, a circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.
详细描述
Objectives:
The primary aim was the assessment of safety and reactogenicity of these vaccines in Gambian adults. The secondary aim was the assessment of immunogenicity and comparison with UK adults given the same vaccines.
Study Area:
The study was conducted in the town of Farafenni, about 200km east of the capital city, Banjul. In this area, malaria is highly seasonal with an entomological inoculation rate between 10-50 bites per year. This study was carried out from January to June, when the incidence of malaria is low.
Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male aged 18-45 years
排除标准
- •Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness
- •Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunocompromise
- •History of splenectomy
- •Haematocrit of less than 30%
- •Serum creatinine concentration >130mmol/L
- •Serum ALT concentration >42IU/L
- •Blood transfusion within one month of the beginning of the study
- •Administration of any other vaccine or immunoglobulin within two weeks before scheduled MVA vaccination
- •Positive HIV antibody test
- •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 for the duration of the study
结局指标
主要结局
Safety and immunogenicity
次要结局
- Comparison of immunogenicity with non-immune UK adults
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine