An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,452
- 试验地点
- 32
- 主要终点
- Percentage of Subjects Who Have a Seroprotective Immune Response
研究概览
简要总结
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
详细描述
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be 40 - 70 years of age, inclusive
- •be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
- •be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- •if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection
排除标准
- •if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
- •has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
- •has a known history of autoimmune disease
- •has previously received any hepatitis B vaccine (approved or investigational)
研究组 & 干预措施
HEPLISAV and/or Placebo
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
干预措施: HEPLISAV and/or Placebo (Biological)
Engerix-B(1)
1.0 mL Engerix-B
干预措施: Engerix-B (Biological)
结局指标
主要结局
Percentage of Subjects Who Have a Seroprotective Immune Response
时间窗: at Week 12 and at Week 32
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
次要结局
- Percentage of Participants With Local and Systemic Reaction to Injections(within 7 days for post-injection reactions)