Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine, HIV-1, AIDS Vaccines, Vaccines, DNA, Dose-Response Relationship, Immunologic, Cytokines, Plasmids, Adjuvants, Immunologic, Drug Administration Schedule, Interleukin, IL2, Ig, IL@/Ig
Eligibility Criteria
Inclusion Criteria HIV negative Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Hepatitis B surface antigen negative Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive Normal thyroid stimulating hormone (TSH) level Exclusion Criteria HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Clinical depression with pharmacological treatment within the past 2 years Active syphilis Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Unstable asthma Type 1 or Type 2 Diabetes Mellitus Thyroid disease requiring treatment Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder requiring medication within the past 3 years Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgement of the investigator, would interfere with the study Pregnant or breast-feeding
Sites / Locations
- Project Brave HIV Vaccine CRS
- Brigham and Women's Hosp. CRS
- Fenway Community Health Clinical Research Site (FCHCRS)
- NY Blood Ctr./Bronx CRS
- NY Blood Ctr./Union Square CRS
- HIV Prevention & Treatment CRS
- Miriam Hospital's HVTU