Immunologic Response of Hepatitis B Single Dose Versus 3-dose Series in Previously Vaccinated HIV-infected Adults at Maharaj Nakorn Chiang Mai Hospital: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults
研究概览
简要总结
This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
详细描述
This study intended to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.
As a part of HBV prevention program, HBV vaccine has been included in Thailand expanded program on immunization (EPI) since 1992. HBV vaccine has been shown to be safe, effective, and has a prolonged protective immunity to HBV infection. Despite the immunity from HBV vaccination could wane overtime, the previous data in general population revealed that HBV vaccine booster could raise the immune in very well. However, the data about booster effects for HBV vaccine among HIV-infected population who previously received a vaccination during their childhood is lagging. Based on previous data of vaccination response in HIV-infected population, the investigators estimate that the protective antibody will rise up to 60% with HBV vaccine one dose booster versus 90% with 3-dose series. Eighty participants, HIV-infected person who were born after HBV vaccine were born after HBV has been included in Thai EPI without evidence of HBV infection nor protective immunity, will be enrolled to this study (with estimation of 5% loss follow up rate). The participants will be randomized in 1:1. The immune response and vaccine safety will be evaluated at 1,7 and 12 months after the first dose HBV vaccine.
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Document of HIV infection
- •Thai nationality
- •Age ≥18 years old
- •Born after 1 January 1992
- •Has been taking antiretroviral drugs for HIV treatment
- •CD4 ≥200 cell/mm3 and VL <50 copies/mL for at least 6 months before enrollment
- •Negative for any HBV and HCV serological markers
- •Willing to sign informed consent
- •Able to follow up
排除标准
- •Active opportunistic infection
- •Pregnancy or breast feeding
- •History of previous hepatitis B vaccine booster
- •History of hypersensitivity to any component of vaccine
- •Malignancy which received chemotherapy or radiation
- •Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
- •On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
- •Renal failure (creatinine clearance <30 mL/min)
- •Transaminitis in the past 3 months (≥ 5 UNL)
- •Decompensated cirrhosis (child-Pugh class C)
- •Unable or not willing to return for follow up
研究组 & 干预措施
Arm A: Single dose hepatitis B vaccine
Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry
干预措施: Hepatitis B vaccine (Biological)
Arm B: 3-dose series of hepatitis B vaccine
3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6
干预措施: Hepatitis B vaccine (Biological)
结局指标
主要结局
Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults
时间窗: 28 weeks after the first dose of HBV vaccination
Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
次要结局
- Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12(12 months after the first dose of HBV vaccination])
- Intensity and frequency of vaccine adverse event (AE)(1 year)
- Anamnestic response at week 4(4 weeks after the first dose of HBV vaccination)
研究者
Romanee Chaiwarith
Associate Professor
Chiang Mai University