Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given … (NCT00384787) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected Adults
United States90 participantsStarted 2006-11
Plain-language summary
The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously).
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* HIV-1 and -2 uninfected
* Good general health
* Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of a 1:12 ratio or greater
* Hepatitis B surface antigen negative
* Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
* Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
* Willing to receive HIV test results
* Able to understand the vaccination procedure
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
* Immunosuppressive medications within 168 days prior to first study vaccination
* Blood products within 120 days prior to first study vaccination
* Immunoglobulin within 60 days prior to first study vaccination
* Live attenuated vaccines within 30 days prior to first study vaccination
* Investigational research agents within 30 days prior to first study vaccination
* Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
* Allergy treatment with antigen injections within 30 days prior to first study vaccination
* Current anti-tuberculosis (TB) preventive therapy or treatment
* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect…
What they're measuring
1
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
Timeframe: After each injection and for 12 months after the first injection
2
Magnitude of HIV-specific T-cell responses assessed by the magnitude of IFN-gamma enzyme-linked immunosorbent spot (ELISpot) responses
Timeframe: 4 weeks after adenoviral vaccine boost
Trial details
NCT IDNCT00384787
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)