An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Local and Systemic Post-injection Reaction Rates
研究概览
简要总结
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
详细描述
This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: This study does not include a control treatment; all subjects will receive treatment 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
- Prevention
- 盲法
- None
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
- •Women of childbearing potential must be willing to consistently use a highly effective method of birth control
排除标准
- •Women who are pregnant or breastfeeding
- •Any previous HBV infection
- •Previous vaccination (1 or more doses) with any HBV vaccine
- •Any previous autoimmune diseases
- •Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
- •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
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL
干预措施: HEPLISAV (Biological)
结局指标
主要结局
Percentage of Participants With Local and Systemic Post-injection Reaction Rates
时间窗: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Local and Systemic post-injection reactions.
次要结局
- Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.(Weeks 4, 8, 12 and 28)
- Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28(Weeks 4, 8, 12, and 28)