Safety of an HIV DNA Vaccine Given to HIV Uninfected Adults

Inclusion Criteria

Participants may be eligible for this study if they:

• Are between the ages of 18 and 40.
• Are at low risk of HIV infection.
• Have access to a participating study site and are available for follow-up for 12 months.
• Complete a questionnaire to evaluate understanding of the study prior to enrollment.
• Are willing to receive HIV test results.
• Are in good general health.
• Do not have hepatitis B.
• Are HCV antibody negative or, if HCV antibody positive, are HCV PCR negative.
• Have had a negative HIV blood test within 8 weeks prior to enrollment.
• Women of childbearing potential must agree to use acceptable methods of contraception.
• Note: All inclusion criteria must be assessed within 56 days prior to study entry.

Exclusion Criteria

Participants may not be eligible for this study if they:

• Have been immunized against smallpox.
• Have received HIV vaccines or placebo in a previous HIV vaccine trial.
• Have used drugs that interfere with the immune system within the past 6 months.
• Have received blood products within 120 days before HIV screening.
• Have received immunoglobulin within 60 days before HIV screening.
• Have received a live vaccine within 30 days prior to initial study vaccine administration.
• Have used investigational research agents within 30 days prior to initial study vaccine administration.
• Have received a killed vaccine or allergy treatment injections within 14 days of study vaccine administration.
• Are currently taking anti-TB therapy.
• Have a history of serious harmful reactions to vaccines.
• Have a history of immune system disease.
• Have a history of unstable asthma.
• Have a history of type I or type II diabetes.
• Have a history of thyroid disease.
• Have a history of tissue swelling with serious episodes.
• Have a history of high blood pressure.
• Have a history of a bleeding disorder that was diagnosed by a doctor.
• Have active syphilis.
• Have a history of cancer, unless it has been surgically removed and in the opinion of the investigator is not likely to recur during the study period.
• Have a history of a seizure disorder.
• Have had their spleen removed.
• Have mental illness that would interfere with compliance with the protocol.
• Have any other conditions that, in the judgement of the investigator, would interfere with the study.
• Are pregnant or breast-feeding.
• Note: All exclusion criteria must be assessed within 56 days prior to study entry.