Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

Inclusion Criteria

Participants may be eligible for this study if they:

• Are between the ages of 18 and 60.
• Are in good general health.
• Have a CD4 count of 400 or more cells/mm3.
• Do not have hepatitis C or active hepatitis B.
• Have had a negative HIV blood test within 8 weeks prior to enrollment.
• Use approved methods of contraception.
• Have access to a participating site and are available for follow-up for 18 months.
• Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
• Give written informed consent.

Exclusion Criteria

Participants may not be eligible for this study if they:

• Are pregnant or breast-feeding.
• Have received a live vaccine within 30 days prior to enrollment.
• Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
• Have used experimental research agents within 30 days prior to enrollment.
• Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
• Have received blood products 120 days before HIV screening.
• Have received immunoglobulin 60 days before HIV screening.
• Have a history of serious harmful reactions to vaccines.
• Have a history of disease of the immune system.
• Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
• Are using or have used (within past 6 months) drugs that interfere with the immune system.
• Have a history of type I or type II diabetes.
• Have thyroid disease.
• Have unstable asthma.
• Are currently taking preventive anti-TB therapy.
• Have a seizure disorder.
• Have a bleeding disorder that was diagnosed by a physician.
• Have had their spleen removed.
• Have angioedema with serious episodes.
• Have active syphilis.
• Have hypertension.
• Have mental problems that would interfere with the protocol.
• Have any other problems that, in the judgment of the investigator, would interfere with the study.
• Have a body mass index less than 20.
• Are allergic or sensitive to egg products.
• Have active tuberculosis.