Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Proportion of participants with protective immunity against HBV
研究概览
简要总结
This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.
详细描述
HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group).
This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infection
- •≥18 years old
- •Received combination antiretroviral therapy for at least 1 year
- •Had a CD4+ cell count < 200 cells/mm3 for at least 1 year
- •Undetectable plasma HIV-1 RNA for at least 1 year
- •Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc),
- •Had no history of previous HBV vaccine
- •Negative for antibody to hepatitis C virus (anti-HCV)
- •No active opportunistic infections (at the time of screening)
- •Willing to sign an informed consent
- •Able to return for follow-up.
排除标准
- •Pregnancy or lactation
- •History of hypersensitivity to any component of the vaccine
- •Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit
- •Renal insufficiency (creatinine clearance <30 mL/min)
- •Decompensated cirrhosis (Child-Pugh class C)
研究组 & 干预措施
HIV-Group 1
Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, and 6
干预措施: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] (Biological)
HIV-Group 2
Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, 2, and 6
干预措施: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] (Biological)
结局指标
主要结局
Proportion of participants with protective immunity against HBV
时间窗: 1 month after vaccination
comparison of proportion of participants who had protective immunity (anti-HBS titer \>=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1
次要结局
- Proportion of participants with high level of immune response against HBV(1 month after vaccination)
- The geometric means of anti-HBs titers(1 month after vaccination)
研究者
Romanee Chaiwarith
Associate Professor
Chiang Mai University