Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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
Sites / Locations
- Alabama Vaccine CRS
- San Francisco Vaccine and Prevention CRS
- Project Brave HIV Vaccine CRS
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
- Brigham and Women's Hosp. CRS
- Fenway Community Health Clinical Research Site (FCHCRS)
- Saint Louis Univ. School of Medicine, HVTU
- NY Blood Ctr./Bronx CRS
- NY Blood Ctr./Union Square CRS
- HIV Prevention & Treatment CRS
- Univ. of Rochester HVTN CRS
- Miriam Hospital's HVTU
- Vanderbilt Vaccine CRS
- FHCRC/UW Vaccine CRS