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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Local and systemic reactions will be monitored 30 and 60 minutes after administration.
研究概览
简要总结
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.
详细描述
- This is a phase I study to assesss the safety and immunogenicity a recombinant MVA encoding a secreted antigen from Mycobacterium. tuberculosis Antigen 85A, delivered intrdermally by a needle injection in healthy BCG naive volunteers.
- 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. 3. Screening
Volunteers will be asked to sign the informed consent form for screening. The following will be performed:
- Medical history and examination
- Laboratory evaluations - including clinical chemistry, haematology, HLA typing, anti-vaccinia antibodies, anti-HBV antibodies, anti-HCV antibodies, anti-HIV antibodies
- Heaf test - to exclude prior exposure to TB
- Urinalysis and urine pregnancy test if female
- Inclusion Criteria
- Healthy adult aged 18-45 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
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Exclusion Criteria
-
Exposure to TB/BCG vaccination 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.
-
Positive Heaf test
-
Confirmed pregnancy
-
Previous MVA immunisations
-
Withdrawal Criteria
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged 18-45 years.
- •Normal medical history and physical examination.
- •Normal urine dipstick, blood count, liver enzymes, and creatinine.
排除标准
- •Exposure to TB/BCG vaccination 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.
- •Positive Heaf test
- •Confirmed pregnancy
- •Previous MVA immunisations
结局指标
主要结局
Local and systemic reactions will be monitored 30 and 60 minutes after administration.
A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.
Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).
次要结局
- Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).