Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 2
- 主要终点
- HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
研究概览
简要总结
In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer.
However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.
详细描述
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3
Intervention:
- Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
- Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
- Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, 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
- •Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
- •Inclusion criteria:
- •HIV infection
- •T CD4 count cell level above 200 per mm3
- •Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
- •unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit
- •Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3
- •Pregnancy test negative at the screening and inclusion visits
排除标准
- •Any injection of the vaccine against Hepatitis B in the medical history
- •Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
- •Any vaccine received one month before the inclusion
- •History of intolerance to any component of GenHevac-B
- •Evolutive opportunistic infection treated the month before the screening visit
- •Severe and acute pyretic infection or unexplained fever the week before inclusion
- •Evolutive hemopathy or solid-organ cancer
- •Prothrombin factor equal or below 50 percent 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 above 7 days) in the last 6 months before the screening visit
- •Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months
- •Splenectomy
- •Decompensated cirrhosis (Child Pugh B or C)
- •Kidney deficient function (creatinine clearance below 50 ml per mn)
- •Other 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
研究组 & 干预措施
A
GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
干预措施: GenHevac B Pasteur (Biological)
B
GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
干预措施: GenHevac B Pasteur (Biological)
C
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
干预措施: GenHevac B Pasteur (Biological)
结局指标
主要结局
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
时间窗: two months after the last injection;week 28, month 18, month 30 and month 42
次要结局
- According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion(two months after the last injection; week 28, month 18, month 30 and month 42)