Document 0090
 DOCN  M94A0090
 TI    Phase I/II vaccination study of recombinant peptide F46 corresponding to
       the HIV-1 transmembrane protein coupled with 2.4 dinitrophenyl (DNP)
       Ficoll.
 DT    9412
 AU    Schwander S; Opravil M; Luthy R; Hanson DG; Schindler J; Dawson A;
       Letwin B; Dietrich M; Case Western Reserve University, School of
       Medicine, Cleveland,; Ohio 44106.
 SO    Infection. 1994 Mar-Apr;22(2):86-91. Unique Identifier : AIDSLINE
       MED/94350512
 AB    In order to evaluate tolerance, toxicity, and in vivo antigenicity, 29
       HIV-1-infected patients (eight with ARC and 21 with AIDS) were
       vaccinated with a synthetic peptide derived from the gp41 transmembrane
       protein of the HIV-1. This peptide had been coupled with 2.4
       dinitrophenyl-Ficoll (F46), a T-cell independent adjuvant. The patients
       received a single intradeltoid injection of either 0.1 or 0.3 mg of F46.
       Five of the individuals with AIDS were boostered, four of them twice.
       Anti-F46 antibody titers were measured before vaccination, and on days
       7, 14, 21, 28, 90, 180 and 270 after vaccination. Anti-F46 titers rose
       at least twofold over prestudy values in 10/21 individuals with AIDS and
       in 1/8 individuals with ARC at least once during the observation period.
       The overall response, however, consisted of only weak antibody
       production that was independent of the dose or patient characteristics.
       No signs of toxicity or of clinical progression related to the
       vaccination were observed in this phase I/II trial of a T-cell
       independent therapeutic vaccine.
 DE    Acquired Immunodeficiency Syndrome/BLOOD/IMMUNOLOGY/*THERAPY  Adjuvants,
       Immunologic/*THERAPEUTIC USE  Adult  Antigens/*IMMUNOLOGY  AIDS
       Vaccines/*THERAPEUTIC USE  AIDS-Related
       Complex/BLOOD/IMMUNOLOGY/*THERAPY  Female  Ficoll/*ANALOGS &
       DERIVATIVES/IMMUNOLOGY  Human  HIV Antibodies/BLOOD  HIV Envelope
       Protein gp41/*IMMUNOLOGY  *HIV-1/IMMUNOLOGY  Immunization,
       Secondary/METHODS  Injections, Intramuscular  Leukocyte Count  Male
       Middle Age  Recombinant Proteins/*THERAPEUTIC USE  Support, Non-U.S.
       Gov't  *T4 Lymphocytes  Vaccines, Synthetic/*THERAPEUTIC USE  CLINICAL
       TRIAL  CLINICAL TRIAL, PHASE I  CLINICAL TRIAL, PHASE II  JOURNAL
       ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).