Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml
研究概览
简要总结
HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer.
However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.
详细描述
Comparison of 2 revaccination strategies in randomized HIV-infected patients with T CD4 cell count above 200/mm3
Intervention:
- Arm A: GenHevac-B® 20μg IM at M0, M1, M6
- Arm B: GenHevac-B® 40μg IM at M0, M1, M6
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •HIV-1 infection
- •T CD4 cell count number above 200 /mm3
- •History of 2 to 4 injections of Hepatitis B vaccine, at any time in the past
- •No history of Hepatitis B vaccination with a double-dose schedule
- •No response to Hepatitis B vaccination: serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative) the previous twelve months and at the screening visit
- •AbHBs titers below 10 IU/ml four weeks after the boost of Genhevac-B® 20μg preceding the randomization
- •unchanged ARV treatment for the last 2 months for patients who are receiving ARV at the screening visit
- •Undetectable HIV RNA for the last 6 months and on-going ARV for any patients with T CD4 cell level below 350/mm3
- •HIV-1 plasma load below 100 000 copies per ml for patients without ARV
- •Negative pregnancy test at the screening visit, and immediately before the Genhevac-B® 20 µg boost injection preceding the randomization
排除标准
- •Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper limit of normal for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper limit of normal for non coinfected patients
- •Any vaccine received during the month preceding the inclusion
- •History of hypersensitivity to any component of GenHevac-B
- •acute opportunistic infection treated the month before the screening visit
- •Severe and acute pyretic infection or unexplained fever the week before inclusion
- •Hemopathy or solid-organ cancer
- •Prothrombin factor equal or below 50% and/or platelets equal or below 50 000 per mm3
- •Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during at least 7 days) in the last 6 months before the screening visit
- •Immunomodulating treatment (interferon, interleukine-2,...) in the last 6 months before the screening visit
- •Splenectomy
- •Decompensated cirrhosis (Child Pugh B or C)
- •Renal failure (creatinine clearance below 50 ml/mn)
- •Other severe immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months,....)
- •Any participation to another clinical trial plan until Week 28
结局指标
主要结局
rate of HIV-infected patients who seroconvert one month after the last vaccination. Seroconversion is defined as anti-HBs titers equal or above 10 mUI per ml
时间窗: one month after the last vaccination (week 28)
次要结局
- According to the vaccine strategy (single-dose or double-dose), comparison of AbHBs titers, permanence of humoral response, intensity of clinical and biological events, and predicting factors related to seroconversion(one month after the last injection ( week 28) and month 18)
- immunological substudy: to understand genetic link between some alleles of HLA-DR and non-response to immunization(at D0)