Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults
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
- Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
研究概览
简要总结
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.
详细描述
West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation [hematology, biochemistry, urinalysis])
- •Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table
排除标准
- •Current active infection process including URI or influenza
- •Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies
- •History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE)
- •Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines
- •History of alcohol or other substance abuse within 1 year of screening
- •Use of corticosteroids or immunosuppressive drugs within 30 days of screening (Use of topical or nasal corticosteroids are not excluded.)
- •Any confirmed or suspected immunosuppressive or immunodeficient condition
- •Administration of immunoglobulins within three months of the first vaccination or planned during the study period
- •Receipt of any vaccines or investigational or non-registered product other than HBV-002 within 30 days prior to screening or planned receipt throughout the study.
- •Receipt of another study vaccines within 30 days prior to screening
- •Receipt of blood products within 6 months of screening
结局指标
主要结局
Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
时间窗: 38 weeks
次要结局
- To assess the immunogenicity of HBV-002(38 weeks)