A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- laboratory measures of safety
研究概览
简要总结
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
详细描述
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.
Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
- Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
- Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Willing to follow all the requirements of the study and available for follow-up for the duration of the study
- •Have understanding of the study and provide written informed consent
- •Willing to undergo HIV testing and counseling and willing to receive HIV test results
- •Willing to use acceptable forms of contraception
排除标准
- •HIV infected
- •Hepatitis B virus infected
- •Hepatitis C virus infected
- •Active or untreated syphilis
- •Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
- •Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
- •Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
- •Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
- •Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
- •Blood transfusion or blood products within 120 days prior to study entry
- •Immunoglobulin within 60 days prior to study entry
- •Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
- •Any other investigational HIV vaccine at any time
- •History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
- •Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
- •Uncontrolled hypertension
- •Pregnant, breastfeeding, or plan to become pregnant
结局指标
主要结局
laboratory measures of safety
systemic reactogenicity signs and symptoms
Local reactogenicity signs and symptoms
adverse and serious adverse experiences
次要结局
- proportion of volunteers with increase in antibodies to rAd5
- proportion of volunteers who test "false positive" on standard HIV testing algorithm.
- Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
- proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
- impact of pre-existing immunity to rAd5 on immunogenicity