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

• Published in: The Journal of infectious diseases 1996-02, Vol.173 (2), p.330-339
• Main Authors: Gorse, G J, Keefer, M C, Belshe, R B, Matthews, T J, Forrest, B D, Hsieh, R H, Koff, W C, Hanson, C V, Dolin, R, Weinhold, K J, Frey, S E, Ketter, N, Fast, P E
• Format: Article
• Language: English
• Subjects: Adult; AIDS Vaccines - administration & dosage; AIDS Vaccines - adverse effects; AIDS Vaccines - immunology; AIDS/HIV; Amino Acid Sequence; Dose-Response Relationship, Immunologic; Double-Blind Method; Enzyme-Linked Immunosorbent Assay; Female; HIV Antibodies - analysis; HIV Envelope Protein gp120 - chemistry; HIV Envelope Protein gp120 - immunology; HIV-1 - immunology; Humans; Lymphocyte Activation; Male; Middle Aged; Molecular Sequence Data; Neutralization Tests; Peptide Fragments - chemistry; Peptide Fragments - immunology
• ISSN: 0022-1899

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.