ISRCTN46804531已完成1 期
Safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route: a phase I randomised active controlled trial
niversity of Oxford (UK)0 个研究点目标入组 24 人开始时间: 2009年12月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23266342
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 - 55 years (both male and female)
- •2. Resident in or near Oxford for the duration of the study period
- •3. Confirmation of prior vaccination with BCG not less than 3 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation)
- •4. Normal medical history and physical examination
- •5. Willingness to allow the Investigators to discuss the individual?s medical history with their GP
- •6. Willingness to use continuous effective barrier contraception for three months after receiving the vaccination (males and females)
- •7. Willingness to use effective contraception for the duration of the study period (females only)
- •8. Agreement to refrain from blood donation during the course of the study
- •9. Give written informed consent
- •10. Agreement to allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials
- •11. Able and willing (in the Investigator?s opinion) to comply with all the study requirements
排除标准
- •1. Clinical, radiological, or laboratory evidence of current active TB infection
- •2. Laboratory evidence at screening of latent TB infection as indicated by a positive ELISPOT test (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola
- •3. Previous vaccination with candidate vaccine MVA85A or another recombinant MVA vaccine
- •4. Clinically significant history of skin disorder, allergy, immunodeficiency (including human immunodeficiency virus [HIV]), cancer (except basal cell carcinoma [BCC] or carcinoma in situ [CIS]), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- •5. History of serious psychiatric condition
- •6. Concurrent oral or systemic steroid medication or the use of other immunosuppressive agents
- •7. History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine
- •8. Any clinically significant abnormality of screening blood or urine tests
- •9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV antibodies
- •10. Female currently lactating, confirmed pregnancy or intention to become pregnant during study period
- •11. Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study period
- •12. Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- •13. Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk or may influence the result of the study or may affect the volunteer?s ability to participate in the study
研究者
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