title: Preclinical and clinical studies on immunogenicity and safety of the HIV-1 p17-based synthetic peptide AIDS vaccine--HGP-30-KLH.
abstract: Immunization with a synthetic HIV-1 p17 peptide analog (HGP-30; aa 85-115 of HIV p17), coupled to a carrier protein (KLH, keyhole limpet hemocyanin) given with alum as the adjuvant induces antibodies which cross-react with both HGP-30 and HIV p17 and clones of cytotoxic and helper T-cells which recognize HGP-30 and HIV p17. Proliferation of lymphocytes in response to HGP-30 has been observed in mice, in HIV-infected individuals and in healthy HIV-seronegative volunteers vaccinated with the p17-based synthetic peptide construct. Cytotoxic T-cell responses against EBV transformed, recombinant p17 pulsed targets were observed using antigen-expanded PBLs from HGP-30-KLH immunized individuals. These results are consistent with predictions that the HGP-30 domain of HIV p17 contains both T- and B-cell epitopes that are recognized by animals and humans. In preclinical toxicology studies in animals and in initial clinical trials in humans the synthetic peptide construct (HGP-30-KLH/alum) has been shown to be safe. This paper summarizes the preclinical immunogenicity and safety data for HGP-30-KLH and presents the initial results from the first Phase 1 clinical trial.
authors.affiliation: Department of Biochemistry and Molecular Biology, George Washington University Medical Center, Washington, DC 20037.
authors.forename: P H
authors.initials: PH
authors.lastname: Naylor
authors.forename: M B
authors.initials: MB
authors.lastname: Sztein
authors.forename: S
authors.initials: S
authors.lastname: Wada
authors.forename: S
authors.initials: S
authors.lastname: Maurer
authors.forename: D
authors.initials: D
authors.lastname: Holterman
authors.forename: J E
authors.initials: JE
authors.lastname: Kirkley
authors.forename: C W
authors.initials: CW
authors.lastname: Naylor
authors.forename: B C
authors.initials: BC
authors.lastname: Zook
authors.forename: R A
authors.initials: RA
authors.lastname: Hitzelberg
authors.forename: C J
authors.initials: CJ
authors.lastname: Gibbs
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology*; D000818:Animals; D004285:Dogs; D004341:Drug Evaluation; D006041:Goats; D006168:Guinea Pigs; D015483:HIV Antibodies / Q000032:analysis; D015488:HIV Antigens / Q000009:adverse effects / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D000882:Haplorhini; D006433:Hemocyanins / Q000008:administration & dosage*; D006801:Humans; D007114:Immunization; D051379:Mice; D002679:Pan troglodytes; D010455:Peptides / Q000009:adverse effects / Q000276:immunology*; D011817:Rabbits; D013602:T-Lymphocytes, Cytotoxic / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*; D054301:gag Gene Products, Human Immunodeficiency Virus
chemical_list: D016915:AIDS Vaccines; C052407:HGP-30 peptide, Human immunodeficiency virus-1; D015483:HIV Antibodies; D015488:HIV Antigens; D010455:Peptides; D014614:Vaccines, Synthetic; D054301:gag Gene Products, Human Immunodeficiency Virus; D006433:Hemocyanins; C032808:keyhole-limpet hemocyanin