A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,428
- 试验地点
- 18
- 主要终点
- Percentage of Subjects With Seroprotective Immune Response
研究概览
简要总结
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
详细描述
This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.
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, Investigator)
入排标准
- 年龄范围
- 11 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give written informed consent
- •Is serum negative for HBV antibodies
排除标准
- •Women who are pregnant or breastfeeding
- •Any previous HBV infection
- •Previous vaccination with any HBV vaccine (1 or more doses)
- •Any autoimmune disease
- •Received any blood products or antibodies within 3 months prior to study entry
- •Ever received an injection with DNA plasmids or oligonucleotides
- •Received any vaccines within 4 weeks prior to study entry
- •Received any other investigational medicinal agent within 4 weeks prior to study entry
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
1.0 mL Engerix-B
干预措施: Engerix-B (Biological)
结局指标
主要结局
Percentage of Subjects With Seroprotective Immune Response
时间窗: Week 12 for HEPLISAV and Week 28 for Engerix-B
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
次要结局
- Percentage of Participants With Local and Systemic Reactions to Injections(Within 7 days post-injection for Post Injection Reactions)