A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants

Date de début de l'étude : 1 décembre 2003

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