VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.
研究概览
简要总结
Background:
People get Zika virus from infected mosquitos. They usually don t get very sick. But birth defects were reported in babies born to mothers who had Zika infection. In rare cases, people with Zika infection had a nervous system disease that causes severe muscle weakness and can be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could help the body build an immune response against the virus.
Objectives:
To see if a new vaccine against Zika virus disease is safe and causes any side effects. To study specific immune responses to the vaccine.
Eligibility:
Healthy people ages 18-50
Design:
Participants will be screened with:
Medical history
Physical exam
Urine tests
Participants will have 18 visits over 2 years.
Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3 separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get it by needle and syringe, others by a device that uses high pressure to push the vaccine through the skin.
Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their temperature and a ruler to measure any skin changes at the injection site. They will record this data for 7 days after each injection.
Other visits last 1-2 hours. These include:
Evaluation of any health changes or problems
Blood tests: Some samples may be used for future research.
Participants with side effects may have extra visits.
...
详细描述
STUDY DESIGN:
This is a Phase I, randomized clinical study to evaluate the safety, tolerability, and immunogenicity of a 3 dose vaccination regimen with the Zika virus (ZIKVwt) DNA vaccine, VRC-ZKADNA090-00-VP. Subjects will be randomized to one of three groups to receive a full 4 mg dose: 1) full dose by one intramuscular (IM) injection with needle and syringe; 2) split dose given as two 0.5 mL IM injections with needle and syringe; 3) split dose given as two 0.5 mL IM injections with PharmaJet, a needle-free injection device. The primary hypothesis is that the investigational ZIKVwt DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that the vaccine will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the vaccine in healthy adults. Secondary objectives are related to the immunogenicity of the vaccine and vaccination regimens.
PRODUCT DESCRIPTION:
The investigational vaccine, VRC-ZKADNA090-00-VP, was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes the wild type (wt) precursor membrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. ZIKVwt
SUBJECTS:
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.
时间窗: Through 44 weeks of study participation.
To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.
时间窗: Through 44 weeks of study participation.
次要结局
- To evaluate the magnitude and the frequency of ZIKV-specific antibody response as measured by neutralization assay.(Four weeks after the first, second and third injections for each regimen.)