VRC 016: A Phase 1b Open-Label, Randomized Clinical Trial to Evaluate Early Innate and Adaptive Immune Responses to the Investigational HIV-1 Vaccines: VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in Ad5 Seronegative Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...
研究概览
简要总结
Background:
The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.
Purpose:
The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.
Eligibility:
Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.
Design:
Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.
The study will have two groups:
<TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.
<TAB>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.
All participants will be asked to provide blood and body fluid samples for testing during the study.
Payment for participation will be provided....
详细描述
Study Design:
This is a hypothesis-generating descriptive study to evaluate the kinetics and pattern of early innate and adaptive immune responses to the VRC recombinant adenoviral vector serotype 5 vaccine, VRC-HIVADV014-00-VP (rAd5). The rAd5 vaccine has been previously administered to more than 1000 study subjects and characterized as safe and immunogenic. A difference in the pattern of vaccine antigen-specific immune responses observed when rAd5 is given as a single agent compared to after priming by a 6-plasmid DNA vaccine, VRCHIVDNA016-00-VP, has previously been reported. This study will randomize vaccine-naive subjects to receive a single injection of rAd5 or to the DNA primerAd5 boost regimen that is now in a large Phase II study. Collection of blood, rectal, oral and genital specimens for characterization of early innate and adaptive immune responses will follow receipt of rAd5. The hypothesis is that the pattern of early innate and adaptive immune responses elicited by the rAd5 vaccine administered after priming with DNA vaccine will be distinctly different from the pattern elicited when rAd5 is administered as a single agent. The primary objectives are to describe the kinetics and pattern of early innate and adaptive immune responses that occur in blood samples early after administration of rAd5 vaccine alone and after administration following 3 DNA prime injections. Secondary and exploratory objectives are related safety, as well as the pattern of immune responses in mucosal samples and in blood samples.
Product Description:
VRC-HIVDNA016-00-VP [6-plasmid DNA vaccine] is composed of 6 closed, circular DNA plasmids that encode for HIV-1 Gag, Pol and Nef proteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in equal proportions. All injections will be at 4 mg dose in a 1 mL volume administered intramuscularly (IM) by Biojector (registered trademark) into deltoid muscle.
VRC-HIVADV014-00-VP (rAd5 vaccine) is composed of 4 recombinant nonreplicating adenoviral vectors that encode for HIV-1 Gag/Pol polyproteins (from clade B) and Env glycoproteins from clade A, clade B, and clade C, which are combined in a 3:1:1:1 ratio, respectively, in a final formulation buffer (FFB). All injections will be at 10(10) PU dose in a 1 mL volume administered IM by needle and syringe into deltoid muscle.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...
次要结局
- To assess the safety and tolerability of the investigational vaccines.