ISRCTN34189114已完成不适用
The safety and immunogenicity of a new tuberculosis (TB) vaccine, MVA85A, in healthy volunteers who are infected with human immunodeficiency virus (HIV): an open label phase I study
niversity of Oxford (UK)0 个研究点目标入组 20 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
- 20
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 adults aged 18 to 55 years (both male and female)
- •2. Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician (and GP, if appropriate)
- •3. HIV antibody positive; diagnosed at least 6 months previously
- •4. CD4 count greater than 350; nadir CD4 not less than 300
- •5. HIV viral load not greater than 100,000 copies per ml
- •6. Written informed consent
排除标准
- •1. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
- •2. Any anti-retroviral (ARV) therapy within the past 6 months
- •3. Any acquired immune deficiency syndrome (AIDS) defining illness
- •4. Chest x-ray (CXR) showing tuberculosis (TB) or evidence of other active infection
- •5. Prior receipt of a recombinant MVA or Fowlpox vaccine
- •6. Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
- •7. Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- •9. Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine (including evidence of cardiovascular disease, history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), history of insulin requiring diabetes mellitus, any ongoing chronic illness requiring ongoing specialist supervision (e.g., gastrointestinal), and chronic or active neurological disease)
- •10. History of greater than two hospitalisations for invasive bacterial infections (pneumonia, meningitis)
- •11. Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of greater than 42 units a week)
- •12. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis C (antibodies to HCV)
- •13. Evidence of serious psychiatric condition
- •14. Any other on-going chronic illness requiring hospital specialist supervision
- •15. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •16. Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
- •17. Any history of anaphylaxis in reaction to vaccination
- •18. PI assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome
研究者
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