Effect of Dose of Hepatitis B Vaccines in Non/Low-response Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 537
- 试验地点
- 2
- 主要终点
- Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
研究概览
简要总结
An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.
详细描述
A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 1-65 years old
- •male or non-pregnant female volunteers
- •provide written informed consents before joining the trial
- •clinically healthy as determined by: medical history inquiring and physical examination
- •negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year
排除标准
- •No history of hepatitis B vaccine
- •receipt of immunoglobulin within the past 1 month
- •allergic to any ingredient of vaccine
- •history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
- •severe acute and chronic diseases
- •autoimmune disease or immune deficiency
- •axillary temperature > 37.0 ℃ over the time of vaccination
结局指标
主要结局
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination
时间窗: day 30 after each vaccination
describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups
次要结局
未报告次要终点
研究者
Wu Jiang
Department of Immunization & Prevention
Centers for Disease Control and Prevention, China