A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 14
研究概览
简要总结
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.
详细描述
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals.
Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •Understanding of vaccination procedure
- •Willing to receive HIV test results and provide informed consent
- •Good general health
- •HIV negative
- •Hepatitis B surface antigen negative
- •Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
- •Not pregnant and agrees to use acceptable forms of contraception
排除标准
- •HIV vaccines or placebo in a prior HIV vaccine trial
- •Immunosuppressive medications within 168 days prior to study
- •Blood products within 120 days prior to study
- •Immunoglobulin within 60 days prior to study
- •Live attenuated vaccines within 30 days prior to study
- •Investigational research agents within 30 days prior to study
- •Medically indicated subunit or killed vaccines within 14 days prior to study
- •Current anti-tuberculosis prophylaxis or therapy
- •Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
- •Autoimmune disease or immunodeficiency
- •Active syphilis infection
- •Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
- •Diabetes mellitus; a participant with past gestational diabetes is not excluded
- •Thyroid disease, including removal of thyroid and diagnoses requiring medication
- •Serious angioedema
- •Hypertension
- •Diagnosis of bleeding disorder
- •Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
- •Seizure disorder requiring medication within the last 3 years
- •Absence of the spleen
- •Mental illness that would interfere with compliance with the protocol
- •Pregnant or breastfeeding
- •Two or more elevated liver function tests