Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults
Completed · Phase 1
Conditions studied: HIV Infections
In brief
The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults.
Key facts
- Study ID
- NCT00486408
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 35
- Starts
- 2007-07-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Good general health
- HIV uninfected
- Weight of 110 pounds or greater
- 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
- Understand the vaccination procedure
- Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit
You may not qualify if…
- 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 90 days prior to first study vaccination or within 14 days after the injection
- Immunoglobulin within 90 days prior to first study vaccination or within 14 days after the injection
- Live attenuated vaccines within 42 days prior to first study vaccination or within 14 days after the injection
- Investigational research agents within 30 days prior to first study vaccination
- Medically indicated subunit or killed vaccines within 5 days prior to first study vaccination or within 14 days after the injection
- Allergy treatment with antigen injections within 30 days prior to first study vaccination
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with the study.
- History of anaphylaxis and/or allergy to vaccine components
- Autoimmune disease or immunodeficiency
- Uncontrolled hypertension
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of the spleen
- Abnormal laboratory values
- Mental illness that would interfere with the study
- Hysterectomy
- Pregnancy or breastfeeding
Where it is running
- Alabama Vaccine CRS — Birmingham, Alabama, United States
- University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
- Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee, United States
- Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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