NCT01213810撤回1 期
Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Immunogenicity
研究概览
简要总结
The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status.
- Trial with medicinal product
- Trial with immunomodulatory product / biological
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All individuals
- •Age >18 years
- •Male, or female with negative urine pregnancy test
- •VZV-seropositive (serologically documented)
- •Agree to use a barrier method of birth control (such as a condom)
- •Written informed consent HIV positive individuals on ART (group A1-A3)
- •Continuous ART for >3 months before baseline
- •No change of ART regimen within 1 month before baseline
- •HIV-RNA (value must be <3 months old )<50 copies/ml at last visit
- •CD4-count (value must be <3 months old) > 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3
- •Participation in the SHCS HIV-positive individuals without ART (group B)
- •HIV-1 RNA >1000 copies/ml (<3 months before baseline)
- •CD4-cell count >500 cells/µl (<3 months before baseline)
- •Participation in the SHCS Healthy HIV-negative volunteers (group C)
- •Negative HIV-screening test (<3 months before baseline)
- •CD4 cell count >500 cells/µl
排除标准
- •Common exclusion criteria
- •Contraindications on ethical grounds
- •Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
- •Pregnancy or breast feeding.
- •Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
- •Known or suspected non-compliance, drug- or alcohol abuse.
- •Specific exclusion criteria
- •Fever > 38.3 °C or acute illness during the last 4 weeks
- •Exposure to chickenpox or shingles within four weeks prior to study entry
- •History of shingles
- •Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids)
- •Household contact with known immunodeficiency (e.g. HIV-positive with CD4 <250 cells/µl)
- •Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination
- •Previous allergic reaction to vaccine components (i.e. neomycin or gelatin)
- •Vaccination with a life attenuated vaccine one month prior to study entry
- •History of chickenpox vaccination
- •Treatment with anti-herpes drugs 4 weeks before baseline
- •Severe coagulation disorder or oral anticoagulant treatment
- •Laboratory exclusion criteria.
- •Thrombocytopenia < 50x 103/?l
- •Haemoglobin <12 g/dl
- •More than threefold elevation of ALT
- •Creatinine of more than150 µmol/l
- •Glucose >10 mmol/l
结局指标
主要结局
Immunogenicity
时间窗: half a year
Geometric mean titer of Varicella zoster virus-specific IgG, VZV-specific T- cells per 106 peripheral mononuclear cells, Frequency of VZV-specific T- cells of total T-cells, CD4+ T-cells in different HIV-positive persons.
Safety
时间窗: half a year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
次要结局
未报告次要终点
研究者
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