VRC 207: A Phase I/1b, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccines, VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ), in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 6
- 主要终点
- Occurrence of adverse events of all severities.
研究概览
简要总结
Background:
- Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.
Objectives:
- To see if an Ebola vaccine is safe and to study immune responses to it.
Eligibility:
- Healthy adults ages 18-65.
Design:
- Participants will be screened through a separate protocol.
- Participants will receive the vaccine injection by needle and syringe into an upper arm muscle. - Participants will stay at the clinic for 3 hours after the injection.
- About 2 days later, participants must speak with clinic staff about how they are doing.
- Every day for 7 days after the injection, participants will record their temperature and symptoms and look at the injection site. They will get a thermometer and a ruler to measure any redness or swelling. They will report any side effects.
- In the first 2 months in the study, participants will have at least 6 clinic visits and 1 phone call. They will have at least 3 other visits over the next 9 months.
- At each visit, participants will be checked for health changes or problems since their last visit. They will be asked how they feel and if they have taken any medicine. Blood will be drawn at most visits. Urine samples may be collected.
详细描述
Study Design: This is a Phase 1/1b, open-label study to examine safety, tolerability and immunogenicity of investigational Ebola vaccines in healthy adults. Part 1 is a Phase 1 dose escalation of the cAd3-EBO vaccine that encodes wild type (WT) glycoproteins (GP) from Zaire and Sudan strains of Ebolavirus. Part 2 is a Phase 1b further evaluation of the cAd3-EBO vaccine at the highest dose and evaluation of the Zaire component, which will be provided as a vaccine designated cAd3-EBOZ. The hypotheses are that the study vaccines, cAd3-EBO and cAd3-EBOZ, will be safe and will elicit immune responses to Ebola GP. The primary objectives are to evaluate the safety and tolerability of the study vaccines administered as single intramuscular (IM) injections at two dose levels. The secondary objectives are related to evaluation of the immunogenicity.
Product Description: VRC-EBOADC069-00-VP (cAd3-EBO) is composed of two recombinant cAd3 vectors in a 1:1 ratio that express Ebola WT GPs from Zaire and Sudan strains. It is formulated at 2 times 10(11) PU/mL.
VRC-EBOADC076-00-VP (cAd3-EBOZ) is composed of a cAd3 vector that expresses Ebola WT GP from the Zaire strain. It is formulated at 1 times 10(11) PU/mL.
VRC-DILADC065-00-VP (diluent) is the formulation buffer used for vaccine production and will be used when needed to prepare the correct dosage of cAd3-EBO and cAd3-EBOZ.
Subjects: Part 1: Healthy adult volunteers, 18 to 50 years old;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older 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
研究组 & 干预措施
Group 4A
cAd3-EBOZ at 1x10(10)PU IM
干预措施: VRC-EBOADC076-00-VP (Biological)
Group 5
cAd3-EBO at 2x10(11)PU IM
干预措施: VRC-EBOADC069-00-VP (Biological)
Group 4B
cAd3-EBOZ at 1x10(11)PU IM
干预措施: VRC-EBOADC076-00-VP (Biological)
Group 1
cAd3-EBO at 2x10(10)PU IM
干预措施: VRC-EBOADC069-00-VP (Biological)
Group 3
cAd3-EBO at 2x10(11)PU IM boost of Ebola DNA WT vaccine (VRC 206 participants)
干预措施: VRC-EBOADC069-00-VP (Biological)
Group 2
cAd3-EBO at 2x10(11)PU IM
干预措施: VRC-EBOADC069-00-VP (Biological)
结局指标
主要结局
Occurrence of adverse events of all severities.
时间窗: Through 4 weeks after the vaccination.
Solicited systemic and local reactogenicity signs and symptoms.
时间窗: Daily for 7 days following each vaccination.
Occurrence of serious adverse events and new chronic medical conditions.
时间窗: Through 48 weeks after the vaccination.
次要结局
- T cell immune responses as measure by intracellular cytokine staining (ICS)(4 weeks after vaccination)
- Antibody responses as measured by ELISA and neutralization assays(4 weeks after vaccination)