A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons

To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in HIV-infected persons. To determine the proportion of study participants immunized who develop new specificities or increased levels of neutralizing and other antibody responses, T-cell proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses. HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes from four of the most common HIV isolates in the United States and Europe, predicted to represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes that generate potentially salutary immune responses and deletes epitopes that generate immune responses which might contribute to further immunopathogenesis. HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes from four of the most common HIV isolates in the United States and Europe, predicted to represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes that generate potentially salutary immune responses and deletes epitopes that generate immune responses which might contribute to further immunopathogenesis. Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide vaccine in incomplete Freund's adjuvant (IFA), or IFA alone as control. Injections are administered on day 0 and at weeks 4, 8, 12, and 24. When patients entered at the lower vaccine dose (Cohort A) reach week 6, the data is reviewed and the higher dose cohort (Cohort B) will begin. When both cohorts reach week 14, data is evaluated and Cohort C begins vaccine administrations at a chosen vaccine dose. Within each cohort, eight patients receive vaccine plus IFA and two patients receive IFA alone. Patients are followed to week 52; 18 clinic visits and four telephone calls are required.