Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Serologic Response
研究概览
简要总结
Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.
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
- Double (Investigator, Outcomes Assessor)
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
- •Older than 18 years of age.
- •Patients infected with Human Immunodeficiency Virus (HIV)
- •Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.
- •Provision of informed consent.
排除标准
- •Proven Hepatitis B virus infection (acute or chronic).
- •Proven hypersensitivity to the vaccine or any of its components.
研究组 & 干预措施
Recombinant Hepatitis B Virus Vaccine (High Dose)
Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.
干预措施: Recombinant Hepatitis B Virus Vaccine (Biological)
Recombinant Hepatitis B Virus Vaccine (Standard Dose)
Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.
干预措施: Recombinant Hepatitis B Virus Vaccine (Biological)
结局指标
主要结局
Serologic Response
时间窗: 4-8 weeks After Exposure
Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.
次要结局
- Systemic Reactions to the Vaccine(One Week after Exposure)
- Local Reactions to Vaccine(One Week after Exposure)
研究者
Felipe Martinez
MD
Universidad de Valparaiso