Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,169
- 试验地点
- 2
- 主要终点
- Anti-HBs
研究概览
简要总结
To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.
详细描述
By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 25-55 years
- •negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
排除标准
- •a history of vaccine component allergies
- •autoimmune diseases
- •immunodeficiency
- •vaccinations received within the past month
- •acute illnesses within the past week
- •fever (axillary temperature exceeding 38°C) within the past three days
结局指标
主要结局
Anti-HBs
时间窗: at the second month after the final injection of each arm
Titers of hepatitis B virus surface antibody
次要结局
未报告次要终点
研究者
Wu Jiang
Director
Centers for Disease Control and Prevention, China