A Phase 1 Systems Biology Study to Investigate Immune Correlates of the Response to an Experimental Hepatitis B Vaccine (HEPLISAV) in Healthy Adults 50 to 70 Years of Age.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
研究概览
简要总结
This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.
详细描述
The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 to 70 years of age, inclusive
- •In good health in the opinion of the principal investigator, based upon medical history and physical examination
- •Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
- •If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10
排除标准
- •Pregnant, breastfeeding, or planning a pregnancy
- •Known history of an autoimmune disease
- •Previously received any hepatitis B vaccine (approved or investigational)
- •Body-mass index (BMI) >30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination
研究组 & 干预措施
HEPLISAV
干预措施: HEPLISAV (Biological)
结局指标
主要结局
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
时间窗: Day 1, 3, and 7 and on Day 28
Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).
时间窗: Day 1, 3, and 7 and on Day 28
次要结局
未报告次要终点