Inclusion Criteria
Patients must have or be:
- Healthy.
- Negative ELISA for HIV.
- Negative for Hepatitis B surface antigen.
- Normal urine dipstick.
- Normal history and physical exam.
- Availability for follow-up for planned duration of the study (60 weeks).
Risk Behavior: Required:
- Lower or intermediate risk sexual behavior as defined by AVEG.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
- Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
- Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.
Patients with any of the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy.
- History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months.
Prior Medication:
Excluded:
- History of use of immunosuppressive medication.
- Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations.
- Use of experimental agents within 30 days prior to study.
- Receipt of blood products or immunoglobulin in the past 6 months.
- Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial.
Risk Behavior:
Excluded:
- Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection.
- History of injection drug use within the last 12 months to enrollment.
- Higher risk sexual behavior as defined by AVEG.