Document 0129 DOCN M9650129 TI A dose-ranging study of a prototype synthetic HIV-1MN V3 branched peptide vaccine. The National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. DT 9605 AU Gorse GJ; Keefer MC; Belshe RB; Matthews TJ; Forrest BD; Hsieh RH; Koff WC; Hanson CV; Dolin R; Weinhold KJ; Frey SE; Ketter N; Fast PE; Division of Infectious Diseases and Immunology, Saint Louis; University School of Medicine, Missouri 63110-0250, USA. SO J Infect Dis. 1996 Feb;173(2):330-9. Unique Identifier : AIDSLINE MED/96162090 AB A phase I double-blind trial was done to examine the safety and immunogenicity of a prototype synthetic human immunodeficiency virus type 1 MN strain (HIV-1MN) third variable region domain (V3) branched peptide vaccine in HIV-1-uninfected healthy adult volunteers. Subjects were randomly assigned to receive 20, 100, or 500 micrograms of vaccine or alum adjuvant control on days 0, 28, and 168. The vaccine was well-tolerated and appeared safe. Induction of binding antibody to V3 MN branched peptide was vaccine dose-related and was detectable in 9 of 10 subjects in the highest-vaccine-dose group. HIV-1MN-neutralizing antibody was detected after the third 500-micrograms dose in 8 of 10 subjects at the 90% neutralization end point. V3 MN peptide stimulated lymphocyte proliferation in 15 (75%) of 20 subjects after vaccination. In conclusion, this prototype vaccine was safe and it induced humoral and cell-mediated immune responses. DE Adult Amino Acid Sequence AIDS Vaccines/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/IMMUNOLOGY Dose-Response Relationship, Immunologic Double-Blind Method Enzyme-Linked Immunosorbent Assay Female Human HIV Antibodies/*ANALYSIS HIV Envelope Protein gp120/CHEMISTRY/*IMMUNOLOGY HIV-1/*IMMUNOLOGY Lymphocyte Transformation Male Middle Age Molecular Sequence Data Neutralization Tests Peptide Fragments/CHEMISTRY/*IMMUNOLOGY Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).