Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
- Conditions
- HIV Infections
- Registration Number
- NCT00071851
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Fenway Community Health Clinical Research Site (FCHCRS)
🇺🇸Boston, Massachusetts, United States
San Francisco Vaccine and Prevention CRS
🇺🇸San Francisco, California, United States
Alabama Vaccine CRS
🇺🇸Birmingham, Alabama, United States
Project Brave HIV Vaccine CRS
🇺🇸Baltimore, Maryland, United States
NY Blood Ctr./Union Square CRS
🇺🇸New York, New York, United States
Saint Louis Univ. School of Medicine, HVTU
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
🇺🇸Baltimore, Maryland, United States
HIV Prevention & Treatment CRS
🇺🇸New York, New York, United States
NY Blood Ctr./Bronx CRS
🇺🇸Bronx, New York, United States
Univ. of Rochester HVTN CRS
🇺🇸Rochester, New York, United States
Miriam Hospital's HVTU
🇺🇸Providence, Rhode Island, United States
Vanderbilt Vaccine CRS
🇺🇸Nashville, Tennessee, United States
FHCRC/UW Vaccine CRS
🇺🇸Seattle, Washington, United States
Brigham and Women's Hosp. CRS
🇺🇸Boston, Massachusetts, United States