Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 8
- 主要终点
- Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
研究概览
简要总结
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers.
Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
详细描述
At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults and their healthy adult household contacts.
排除标准
- •Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of
- •Childcare workers who have direct contact with children 5 years old and younger.
- •Resides with Household Contacts who are under the age of 18 or over the age of
- •Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
- •Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
研究组 & 干预措施
Cohort 1
three vaccinations of 10^7vp Ad4-H5-Vtn or placebo
干预措施: Placebo (Other)
Cohort 1
three vaccinations of 10^7vp Ad4-H5-Vtn or placebo
干预措施: Sanofi Pasteur Influenza Virus Vaccine, H5N1 (Biological)
Cohort 2
three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo
干预措施: Placebo (Other)
Cohort 2
three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo
干预措施: Sanofi Pasteur Influenza Virus Vaccine, H5N1 (Biological)
Cohort 3
three vaccinations of 10^9 Ad4-H5-Vtn or placebo
干预措施: Placebo (Other)
Cohort 3
three vaccinations of 10^9 Ad4-H5-Vtn or placebo
干预措施: Sanofi Pasteur Influenza Virus Vaccine, H5N1 (Biological)
Cohort 4
three vaccinations of 10^10 Ad4-H5-Vtn or placebo
干预措施: Placebo (Other)
Cohort 4
three vaccinations of 10^10 Ad4-H5-Vtn or placebo
干预措施: Sanofi Pasteur Influenza Virus Vaccine, H5N1 (Biological)
Cohort 5
three vaccinations of 10^11 Ad4-H5-Vtn or placebo
干预措施: Placebo (Other)
Cohort 5
three vaccinations of 10^11 Ad4-H5-Vtn or placebo
干预措施: Sanofi Pasteur Influenza Virus Vaccine, H5N1 (Biological)
结局指标
主要结局
Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
时间窗: Throughout trial (reactogenicity for 7 days following each vaccination)
Immunogenicity (humoral) defined by H5 HAI titer
时间窗: At all available timepoints
次要结局
- Replication/excretion of Ad4-H5-Vtn virus(Throughout trial)
- Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion(Throughout trial)
- Immunogenicity (humoral), defined by Ad4 antibody response(At all available timepoints)