Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.
详细描述
The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161B vaccine at one of five doses to see which does might be the best. VaxInnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female aged 18 - 49 years inclusive
- •give written informed consent to participate
- •healthy, as determined by medical history, physical examination
- •comprehension of the study requirements
- •willing to provide multiple blood specimens collected by venipuncture.
排除标准
- •Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
- •clinically significant abnormal liver function tests
- •positive serology for HBsAg or HCV antibodies
- •impaired immune responses
- •history of anaphylactic type reaction to injected vaccines
- •history of drug or chemical abuse in the year prior to screening
- •history of Guillain-Barré Syndrome
- •history of chronic obstructive pulmonary disease or history of other lung disease
结局指标
主要结局
Safety
时间窗: 1 year
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headache, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.
次要结局
- Immunogenicity(6 mos.)