AEGiS-06IAC: Phase I study of HGP-30, an HIV p17 synthetic peptide analogue sub-unit vaccine in humans.

6th International AIDS Conference

San Francisco, California, USA — June 20-23, 1990

Phase I study of HGP-30, an HIV p17 synthetic peptide analogue sub-unit vaccine in humans.

Int Conf AIDS 1990 Jun 20-23; 6:327 (abstract no. 1054)
Stambuk D, Vallerich M, Youle M, Rios A, Naylor P, Sarin P, Goldstein A, Gazzard B; St. Stephen's/Westminster Hospital, London, England

OBJECTIVE: To evaluate toxicity and safety of administration to humans of HGP-30 vaccine and their antibody response.

METHODS: Nineteen Western Blot HIV negative male volunteers were injected intramuscularly with escalating doses (10, 25, 50ug/kg body weight) of a synthetic peptide HGP-30 coupled to Keyhole Limpet Hemocyanin and administered with alum. A total of 3 injections were given at weeks 0, 6, 14 to subjects divided in 3 dose-related groups and monitored two-weekly for evidence of toxicity for a median period of 18 weeks (2-24).

RESULTS: Two of 19 volunteers withdrew. In the 17, still in study, there was no evidence of toxicity and the only complaint was a varying degree of pain at the injection site lasting for 1 - 3 days. Six of 15 (40%) humans who received a full vaccination course developed reactivity to p17 and/or p24 on Western Blot. The Western Blot of all other HIV antigens remained negative in all patients except one who had transient weak positivity to p66 and gp120/160.

CONCLUSION: HGP-30 vaccine applied in human males seems to be safe, non-toxic and is immunogenic.

Keywords: AEGIS, HIV Antigens, AIDS Vaccines, HIV, Vaccines, Synthetic, Peptides, HIV Antibodies, Vaccination, HIV Infections, Hemocyanin, HIV Seropositivity, Alum Compounds, HIV Seronegativity, HIV p17 antigen peptide HGP-30, keyhole-limpet hemocyanin, aluminum sulfate, Human, Male, immunology, ICA6

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