NCT02323308已完成不适用
Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Average titers of anti-HBs Ab
研究概览
简要总结
The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+ adults patients
- •negative HBsAg
- •negative a-HBs Ab
- •positive HBc Ab
- •without HBV - vaccination
- •CD4 cell above 200 /mm3
- •HIV viral load below 50 copies/mL
排除标准
- •positive HBs antigenemia in the past
- •transaminitis above fivefold upper normal limit
- •PT<50% or Platelet <50 000/mm3
- •ongoing opportunistic infection
- •ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
结局指标
主要结局
Average titers of anti-HBs Ab
时间窗: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
Analysis of B-cell phenotype and maturation
时间窗: at baseline and at week 28
Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile
时间窗: at Day 0, inclusion visite
次要结局
- Detection of IgG+ memory B cells specific for HBcAg or HBs Ag(at baseline and 28 weeks after the first dose HBV vaccin)
- Number of patients with HBsAb titers as protective titer>10 IU/L(at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin)
- - Detection of HBV preS2 and S-specific T cells(at day 0 and week 28)
研究者
研究点 (1)
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