Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
研究概览
简要总结
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.
详细描述
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 18 to
- •Body weight ≥ 110 pounds (50 kg).
- •Satisfactory medical condition established by medical history and physical examination.
- •Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.
排除标准
- •Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
- •Abuse of drugs or alcohol within 12 months prior to screening.
- •Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Receipt of any vaccination within 30 days prior to screening.
- •Receipt of blood products within 6 months of screening.
- •Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
- •History of flavivirus infection.
- •No easy access to a fixed or mobile telephone.
- •History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of > 1 year.
- •Donation of ≥ 450 mL of blood within the previous 12 weeks.
研究组 & 干预措施
10 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
干预措施: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) (Biological)
50 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
干预措施: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel) (Biological)
Placebo
Administration of placebo vaccine at Weeks 0, 4, and 8.
干预措施: Placebo for DEN1-80E (Biological)
结局指标
主要结局
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
时间窗: Assessed at each study visit
次要结局
- To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses(Every 2 weeks during treatment)