A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have or be:
• • Healthy
• • Negative ELISA for HIV.
• * One or more HLA alleles:
• • A33, B8, B27, B35, or Bw62.
• • Negative for Hepatitis B surface antigen.
• • Normal urine dipstick.
• • Normal history and physical examination.
• • Availability for follow-up planned duration of the study (12 months).
• • Viable EBV line prior to enrollment.
• Risk behavior: Required:
• • Lower 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 (e.g., recent suicidal ideation or present psychosis).
• • Active syphilis. NOTE: If the serology is documented to be false positive due to a remote (\> 6 months) treated infection, the volunteer is eligible.
• • Hepatitis B surface antigenemia.
• • 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, autoimmune disease.
• • History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of a cure.
• • 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.
• • History of suicide attempts or past psychosis.
• 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.
• Prior Treatment:
• Excluded:
• • Receipt of blood products or immunoglobulin in the past 6 months.
• 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 prior to enrollment.
• • Higher or intermediate risk sexual behavior as defined by AVEG.