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 States, Peru90 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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)