Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients, Co-infected or Not With HBV and/or HCV. HEP.A.VAC Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
研究概览
简要总结
Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.
详细描述
RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected patients. The primary objective of the study is to compare the immunogenicity (percentage of patients with anti-HAV antibodies > 20 mUI/ml at month 7) of 2 strategies (2 doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and 500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with the 2 strategies, the durability of the seroprotection 12 months after the end of vaccination, and the safety. The PARAMATERS than may have an effect on the immune response will be evaluated.
This open, prospective, study have included 99 patients, aged from 18 to 55 years old. Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O, 4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28 for immunogenicity and week 72 for long term analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3
排除标准
- •prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time < 50%, platelets< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity > 2 ULN for non co-infected patients, > 5 ULN for co-infected patients
研究组 & 干预措施
group1:3 administrations of Havrix
group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24
干预措施: group1 (Drug)
group2: 2 administrations of Havrix
group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24
干预措施: group2 (Drug)
结局指标
主要结局
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
时间窗: during de study
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination
次要结局
- anti-HAV antibodies mean geometric titers 7 months after the first vaccination(during the study)
- durability of seroprotection 1 year after the end of vaccination(during the study)
- safety(during the study)
- predictive factors of vaccinal response(during the study)