A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals

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

Keywords

ClinConnect Summary

Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.

Healthy volunteers are randomized to one of eight groups. All patients receive initial immunization with HIVAC-1e, followed by two boosts at months 8 and 12 of rgp120/HIV-1SF2 (BIOCINE), rgp120/HIV-1IIIB (Genentech), rgp120/HIV-1MN (Genentech), or gp160 MN (Immuno-AG). Addit...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects must have:
• • Normal history and physical exam.
• • Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
• • No history of smallpox (vaccinia) vaccination.
• • Normal urinalysis.
• • Absolute CD4 count = or \> 500 cells/mm3.
• • Exclusion Criteria
• Co-existing Condition:
• Subjects with the following conditions are excluded:
• • Hepatitis B surface antigenemia.
• • Medical or psychiatric condition that precludes compliance with the protocol.
• Subjects with the following prior conditions are excluded:
• • History of immunodeficiency or chronic illness.
• • Eczema within the past year.
• Prior Medication:
• Excluded:
• • Prior experimental HIV vaccine.
• • Prior smallpox vaccine.
• • Immunoglobulin administration within 2 months prior to enrollment.
• • Any experimental agent within 2 months prior to enrollment.
• • History of use of immunosuppressive medications.
• Prior Treatment:
• Excluded:
• • Blood or blood product transfusion within the past 6 months.
• • 1. Current high risk for HIV transmission (persons previously at high risk for HIV transmission can be enrolled provided they have a negative HIV screening and no high-risk behavior has been practiced within the last 6 months).
• • Household contact with anyone who is pregnant, has eczema, is less than 12 months of age, or has immunodeficiency disease or is using immunosuppressive medications.