A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).
研究概览
简要总结
This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years.
详细描述
This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years
- Selection of volunteers
Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will be told of the theoretical risk of congenital anomaly should they become pregnant during the study and only those who undertake to take precautions to avoid pregnancy during the study period will be eligible. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.
2 Screening
Volunteers will be asked to sign the informed consent form for screening. The following will be performed:
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged 18-55 years.
- •Normal medical history and physical examination.
- •Normal urine dipstick, blood count, liver enzymes, and creatinine.
排除标准
- •Exposure to TB at any point. Previous residence in a TB endemic area.
- •Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- •Oral or systemic steroid medication or the use of immunosuppressive agents.
- •Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- •Heaf test greater than Grade II
- •Confirmed pregnancy
- •Previous MVA immunisations
结局指标
主要结局
The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).
次要结局
- Immunogenicity will be measured: The induction of T cell responses (as measured by an interferon-gamma Elispot assay) will be performed on PBMCs from blood samples taken at the specified time points.
- Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively.
- Antibody titres will be measured from frozen plasma samples.