Kahn J, Coleman R, Stites D, Scillian J, Murcar N, Naylor P, Sarin P, Simmon V, Heseltine P; International Conference on AIDS.
Int Conf AIDS. 1992 Jul 19-24; 8: B93 (abstract no. PoB 3037).
AIDS Division, SFGH.
OBJECTIVES: This is a Phase 1 two site, dose escalation study to evaluate the clinical safety and immunologic responses in HIV uninfected subjects vaccinated with HGP-30 conjugate mixed with alum. METHODS: HGP-30 is a 30 amino acid synthetic peptide from an immunogenic region of the p17 HIV protein. p17 is detected on the surface of HIV and on the surface of HIV infected cells. p17 appears conserved from different isolated and p17 antibodies decline prior to the onset of AIDS and prior to the loss of other HIV directed antibodies. For purposes of vaccination, HGP-30 is bound to the carrier protein KLH and mixed with alum. Subjects were in good health, with normal laboratory values with two negative HIV antibody tests by ELISA and Western Blot separated by at least 2 weeks. Negative was defined as no bands. Vaccinations were performed on weeks 0, 4, 10 with a total 52 week follow-up. The dose level (subjects) were as follows: 10 micrograms/kg (6), 25 micrograms/kg (6), 50 micrograms/kg (6), 100 micrograms/kg (3). RESULTS: Vaccination with HGP-30 KLH alum vaccine was well tolerated. Most subjects had local pain with vaccination, Clinical laboratory parameters were unchanged by vaccination. There was no significant changes in any lymphocyte subset population or lymphocyte functional assay as measured by mitogen (PHA), recall antigens (CMV, tetanus) or NK cell cytotoxicity, proliferative responses to HGP-30, KLH and HGP-30 KLH conjugate and CTL responses to autologous EBV transformed cells were observed. CONCLUSIONS: Local pain at the injection site was common but not clinically limiting. Clinical laboratory parameters were not affected by administration of the vaccine. There was no immunotoxicity and no effect on T-cell functional studies. ELISA antibodies were transient and developed in a minority of subjects. Neutralizing antibodies are being evaluated. T-cell proliferative responses are variable and occurred in a minority of subjects. CTL responses were observed in 4 of the first 11 subjects and 3 others developed a nearly positive CTL responses. In general CTL responders also developed T-cell proliferative responses to HGP-30.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Alum Compounds
- Amino Acids
- Clinical Trials, Phase I as Topic
- Enzyme-Linked Immunosorbent Assay
- HIV
- HIV Antibodies
- HIV Antigens
- HIV Infections
- HIV Seronegativity
- HIV Seropositivity
- Hemocyanin
- Peptides
- T-Lymphocytes
- T-Lymphocytes, Cytotoxic
- Vaccination
- aluminum sulfate
- immunology
- keyhole-limpet hemocyanin
Other ID:
UI: 102199384
From Meeting Abstracts