ISRCTN12385972已完成不适用
The safety and immunogenicity of new tuberculosis (TB) vaccine candidates FP85A and MVA85A, in healthy adults who have previously been immunised with Bacillus Calmette-Guerin (BCG), using a prime-boost delivery schedule: a phase I open label study
niversity of Oxford (UK)0 个研究点目标入组 36 人开始时间: 2009年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy adult aged 18 to 50 years (male or female)
- •2. Resident in or near Oxford for the duration of the vaccination study
- •3. Immunisation with BCG greater than 12 months prior to enrolment in the study
- •4. Able and willing (in the Investigators? opinions) to comply with all study requirements
- •5. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- •6. Agreement to practice barrier contraception from the start of the study until 3 months after the final vaccination
- •7. For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the entire duration of the study
- •8. Agreement to refrain from blood donation during the course of the study
- •9. Written informed consent
排除标准
- •1. Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- •2. Prior receipt of a recombinant MVA or fowlpox vaccine
- •3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •4. Any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (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)
- •5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- •6. Any history of anaphylaxis in reaction to vaccination
- •7. Close contact with fowl during the study period (e.g. chicken farming)
- •8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •9. History of serious psychiatric condition
- •10. Any other chronic illness requiring hospital specialist supervision
- •11. Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- •12. Seropositive for hepatitis B surface antigen (HBsAg)
- •13. Seropositive for hepatitis C virus (antibodies to HCV)
- •14. For females, pregnancy, lactation or willingness/intention to become pregnant during the study
- •15. Any other significant disease, disorder or finding, which, in the opinion of the Investigators, 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 in the study
- •16. Mantoux skin test equal to or greater than 15 millimetres
- •17. Screening Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool
- •18. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
研究者
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