HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Number of Participants Who Failed to Respond to 5 or More Doses of Hepatitis B Vaccine With Aluminum Adjuvant Who Respond to Hepatitis B Vaccine With CpG Adjuvant Series
研究概览
简要总结
This study is being done to determine if healthcare workers who have previously failed to respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant (hepB-CpG) (Heplisav-B)
详细描述
Study Intervention Each individual who has completed at least 5 doses hepB vaccine with aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited to receive the hepB-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface antigen will be measured after the first dose during the visit for the administration of the second dose. One month after completion of the series, each immunized individual will have another anti-HBs measured.
Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs < 10mIU/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to provide informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Healthcare workers who have received at least 5 doses of hepatitis B vaccine with aluminum adjuvant and have antiHBs < 10mIU/ml
- •Females of childbearing potential will be asked about the possibility of pregnancy as is the standard of care for immunization services. If a female indicates that she may be pregnant, study participation will be postponed until pregnancy is completed or the female reports that she is not pregnant.
排除标准
- •Women who are pregnant or planning on becoming pregnant during the study
- •Allergy to the vaccine or a component of the vaccine
- •Not suitable for study participation due to other reasons, such as inability or unwillingness to comply with the study procedures, at the discretion of the investigators
结局指标
主要结局
Number of Participants Who Failed to Respond to 5 or More Doses of Hepatitis B Vaccine With Aluminum Adjuvant Who Respond to Hepatitis B Vaccine With CpG Adjuvant Series
时间窗: one month after dose 2 (up to 84 days on study)
Response is defined as AntiHBs \>10 mIU/ml following two doses of hepB-CpG
次要结局
- Proportion of Participants Who Are Nonresponders With Each Risk Factor(one month after dose 2 (up to 84 days on study))
- Number of Participants Who Respond to a Single Dose of hepB-CpG(one month after dose 1 (up to 42 days on study))