A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
研究概览
简要总结
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers
详细描述
Study Design: The study is a non-randomized clinical trial. Twelve volunteers will be recruited. They would be given 5x107 pfu of the MVA85A vaccine intradermally. The subjects will be required to stay in the unit for an hour after the vaccination. Local and systemic adverse events would be recorded. Blood samples will be taken at the screening visit, day of immunisation, 1 week after the vaccination, then at 2, 4, 8, 12 and 24 weeks after the vaccination.
Screening:
Details of the study will be carefully discussed with the subjects and informed consent approved by the combined MRC/Gambian government ethics committee prior to any study-related evaluations being performed. The subjects that agree to enroll and have signed consent documentation will be assessed at the AFTBVAC clinic at MRC.
Entry
Subjects will be recruited at the MRC AFTBVAC clinic. Subjects will be screened in the eight weeks prior to entering the study. The screen will consist of checking subject eligibility and a full physical examination. The following will be carried out: height, weight, vital signs, haematology (haemoglobin, packed cell volume, white cell counts, platelets, blood film for malaria parasites), serum chemistry (electrolytes and creatinine, liver enzymes, serum bilirubin and proteins), Mantoux test, ELISPOT, Chest X-ray, anti-vaccinia antibodies, anti-HBV antibodies, , anti-HIV antibodies, urinalysis. All chest X-rays will be reviewed by two clinicians to confirm no radiological sign of Tuberculosis.
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.
- •Normal medical history and physical examination. Minor physical ailments e.g. Fungal skin infections, will not be sufficient to define a physical examination as abnormal.
- •Normal urine dipstick, blood count, liver enzymes, and creatinine
- •Frequency <4 SFU per/well/3x105 PBMC as determined by ELISPOT with ESAT6/CFP-10 antigens and less than 100 SFU per/well/1x106 PBMC as determined by ELISPOT with PPD.
- •Mantoux negative (0.0 mm induration).
- •Normal Chest X-ray.
- •Willing to donate blood samples as required by the protocol
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
- •Serum ALT concentration >80IU/L
- •Blood transfusion within one month of the beginning of the study
- •History of vaccination with any previous experimental poxvirus vaccine
- •Administration of any other vaccine or immunoglobulin within two weeks before or two weeks after vaccination.
- •Positive HIV antibody test, evidence of HBV (Hepatitis B vaccination is not an exclusion criteria)..
- •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
- •Untreated malaria infection
结局指标
主要结局
Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
次要结局
- Immunogenicity of this vaccine. It is expected that the vaccine will stimulate T cell responses, which will be measured by interferon -gamma Elispot assays.