Measurement of Human T-Cell Turnover Following Vaccination With the Tuberculosis Vaccine MVA85A
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
- Proliferation and disappearance rates of responding antigen-specific T-cells
研究概览
简要总结
This study examines the early immune response to a new vaccine (MVA85A) being developed to combat tuberculosis (TB).
详细描述
MVA85A is a promising new vaccine designed to prevent tuberculosis (TB) by dramatically boosting pre-existing responses to BCG, the only licensed vaccine against the disease at present. In BCG vaccinated individuals it induces a strong immune response. However little is known about the evolution of that response or of the kinetics of T-cells (the immune cells that respond to the vaccine) immediately following vaccination. Crucially, the outcome of this process may determine long term protection from disease.
This study aims to define the early immune response to MVA85A and is the first to apply a safe, non-radioactive 'label' - deuterium - to measure T-cell turnover following vaccination. This labelling approach has been used successfully by the study collaborators to examine immune cell kinetics in human clinical studies in the UK over the last 8 years. The resulting data will provide insight into the immune response generated by MVA85A and aid in the future design and modification of other T-cell inducing vaccines.
Group 1 (Immune responses only)
Previous human studies of MVA85A have described the immune response to vaccination at fixed timepoints but not in between. The investigators will vaccinate four volunteers and measure immune responses daily for 14 days. This will provide important new data and aid interpretation of kinetics data from groups 2 and 3.
Groups 2 & 3 (Labelling)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged 18 to 50 years
- •Immunization with BCG greater than 12 months prior to enrolment in the study
- •Resident in or near Oxford for the duration of the study
- •Able and willing (in the investigator's opinion) to comply with all study requirements
- •Given written informed consent
- •Willing to allow the investigator to request medical information from, or discuss the volunteer's medical history with the volunteer's General Practitioner
- •Willing to allow the investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials
- •For women only, willingness to practice continuous effective contraception during the study
- •Agreement to refrain from blood donation during the course of the study
排除标准
- •Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- •Prior receipt of a recombinant MVA vaccine
- •Screening test suggesting the possibility of latent TB infection- i.e. Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool
- •Any clinically significant abnormal finding on screening blood tests or urinalysis (see Appendix B for guidance on study reference ranges)
- •Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- •Any history of anaphylaxis
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •History of serious psychiatric condition
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- •Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (antibodies to HCV)
- •Pregnancy, lactation or willingness/intention to become pregnant during the study
- •Any other chronic illness requiring hospital specialist supervision
- •Any other significant disease, disorder or finding, which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate fully in the study
结局指标
主要结局
Proliferation and disappearance rates of responding antigen-specific T-cells
时间窗: Within four weeks of vaccination
次要结局
- Immunogenicity(Within three months of vaccination)
- Safety(Within three months of vaccination)