APPENDIX B

INCLUSION CRITERIA

• Age: 18-60 [No more than 10% of the volunteers to be over age 50]
• Sex: Male or Female [For females, negative pregnancy test at time of entry and assurance that adequate birth control measures will be used for one month prior to immunization and the duration of the study.]
• Normal history and physical examination
• Lower risk sexual behavior as defined by AVEG
• Normal complete blood count and differential defined as:
  • Hematocrit >34% for women; >38% for men
  • White count >3500 cells/mm³ with normal differential
  • Total lymphocyte count >800 cells/mm³
  • Absolute CD4 count >400 cells/mm³
  • Platelets (150,000550,000)
• Normal ALT (<1.5 x institutional upper normal limit) and Creatinine (<1.6 mg/dl)
• Normal urine dipstick with esterase and nitrite
• Negative for Hepatitis B surface antigen
• Negative ELISA for HIV within 8 weeks of immunization
• Availability for follow-up for planned duration of the study (___ months)

EXCLUSION CRITERIA

• * History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications. Individuals with a history of cancer are excluded unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
• * Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis.
• Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection; specific exclusions include:
  • History of injection drug use within the last 12 months prior to enrollment
  • Higher or intermediate risk sexual behavior as defined by the AVEG
• 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
• 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]
• * Any history of anaphylaxis or history of other serious adverse reactions to vaccines
• * History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension)
• Prior receipt of HIV-1 vaccines
• Pregnant or lactating women

* These items were modified and adopted in May 1994.
** These standard criteria were implemented by the AVEG in May 1993.