Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
研究概览
简要总结
The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.
详细描述
- A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
- After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes
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
盲法说明
No masking
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
- •Aged ≥ 18 years
- •On combination antiretroviral therapy (cART)
- •CD4 ≥ 200 cell/mm3 for ≥ 1 year
- •HIV viral load < 20 copies/ml for ≥ 1 year
- •Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening
排除标准
- •Pregnancy
- •Previous HBV vaccination
- •Intolerance to any component of HBV vaccine
- •Transaminitis in the past 3 months (≥ 5 UNL)
- •Ongoing opportunistic infection (OI)
- •Active malignancy, with current chemotherapy or radiotherapy
- •Systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months
- •Other immunocompromised disorders (e.g. solid organ transplant)
- •Asplenism
- •Renal insufficiency (CrCl ≤ 30 mL/min)
- •Decompensated cirrhosis (Child-Pugh C)
结局指标
主要结局
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
时间窗: 28 weeks after the first dose of HBV vaccination
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
次要结局
- Anamnestic response at week 4(4 weeks after the first dose of HBV vaccination)
- Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12(12 months after the first dose of HBV vaccination)
- Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12(28 weeks and 12 months after the first dose of HBV vaccination)
- Intensity and frequency of vaccine adverse event (AE)(1 year)
- Geometric mean titers of anti-HBs Ab at week 28 and month 12(28 weeks and 12 months after the first dose of HBV vaccination)
- Predictive factors associated with response to vaccine (age, sex, CD4 count)(1 year)
研究者
Romanee Chaiwarith
Associate Professor
Chiang Mai University