VRC 315: A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boost
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Solicited adverse events (reactogenicity).
研究概览
简要总结
Background:<TAB>
- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone.
Objectives:
- To see if 2 vaccines for bird flu, are safe and tolerable for humans.
- To study immune responses to these vaccines.
Eligibility:
- Healthy adults 18 60 years old.
Design:
- Participants will be screened through a separate protocol.
- Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines.
- Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected.
- Participants will receive vaccinations at 2 of the visits, 16 weeks apart.
- The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle.
- Participants will be observed for at least 30 minutes after each vaccination.
- Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily.
- Participants will have follow-up blood tests.
详细描述
VRC 315 STUDY:
A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or with Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime with MIV Boost Compared to MIV Prime with MIV Boost
STUDY DESIGN:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of prime-boost vaccination regimens against H7N9 Influenza. A vaccination regimen with the VRC-FLUDNA071-00-VP (H7 DNA) vaccine administered alone or concurrently in different arms with A/Shanghai/2/2013(H7N9) (MIV) as prime followed by inactivated MIV boost will be compared to MIV-MIV prime-boost with a 16 week boost interval. The primary hypothesis is that all the H7 DNA prime-MIV boost, DNA+MIV prime-MIV boost, and MIV-MIV study regimens will be safe for human administration. A secondary hypothesis is that the H7 DNAMIV regimen will elicit a greater frequency and/or magnitude of antibody against H7 than the MIV-MIV regimen. The primary objective is to evaluate the safety and tolerability in healthy adults of the investigational vaccine regimens. Secondary objectives are related to the immunogenicity of the vaccination regimens.
PRODUCT DESCRIPTION:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Solicited adverse events (reactogenicity).
时间窗: Daily for 7 days following each vaccination.
Adverse events of all severities.
时间窗: Through 28 days after each injection.
Serious adverse events, new chronic medical conditions and influenza-like illnesses
时间窗: From first vaccination to last study visit
次要结局
- H7-specific antibody response as measured by HAI assay(Day 0 (baseline) and 2 weeks after the boost vaccination.)