VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.
研究概览
简要总结
Background:
The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.
Objective:
To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.
Eligibility:
Healthy people ages 18 35
Design:
Participants will be screened through a separate protocol with:
- Medical history
- Physical exam
- Lab and urine tests
Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests.
Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group.
Vaccine visits last 4-6 hours. Others last 1-2 hours.
Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day.
Participants might have extra visits and blood tests if they have health changes.
详细描述
Study Design:
This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV) disease. Vaccination regimens with the VRC-ZKADNA085-00-VP (ZIKV DNA) vaccine administered on Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group 3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested. The primary hypothesis is that the ZIKV DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that all vaccine regimens will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens in healthy adults. Secondary objectives are related to the immunogenicity of the vaccination regimens.
Product Description:
The investigational VRC-ZKADNA085-00-VP vaccine was developed by the Vaccine Research Center (VRC), NIAID, and is composed of a single closed-circular DNA plasmid that encodes the wild type precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. Vaccine is supplied in single dose vials at a concentration of 4 mg/mL. ZIKV DNA vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid muscle.
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 35 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
研究组 & 干预措施
Group 1
ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 8.
干预措施: VRC-ZKADNA085-00-VP (Biological)
Group 2
ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 12.
干预措施: VRC-ZKADNA085-00-VP (Biological)
Group 4
ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0,Week 4 and Week 20.
干预措施: VRC-ZKADNA085-00-VP (Biological)
Group 3
ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0, Week 4 and Week 8.
干预措施: VRC-ZKADNA085-00-VP (Biological)
结局指标
主要结局
To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.
时间窗: Through 44 weeks of study participation
次要结局
- To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay.(Four weeks after the second and third injections for each regimen.)