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1996-03-09
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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).