       Document 0908
 DOCN  M9620908
 TI    Anti-alpha interferon immunization: safety and immunogenicity in
       asymptomatic HIV positive patients at high risk of disease progression.
 DT    9602
 AU    Gringeri A; Santagostino E; Mannucci PM; Siracusano L; Marinoni A;
       Criscuolo M; Carcagno M; Fall LS; M'Bika JP; Bizzini B; et al; A.
       Bianchi Bonomi Hemophilia and Thrombosis Center, Institute of; Internal
       Medicine, IRCCS Maggiore Hospital, Milan, Italy.
 SO    Cell Mol Biol (Noisy-le-grand). 1995 May;41(3):381-7. Unique Identifier
       : AIDSLINE MED/96059398
 AB    A randomized, placebo-controlled trial was designed to evaluate safety
       and immunogenicity of an anti-cytokine vaccine in high risk HIV-positive
       patients. This strategy was aimed to modulate the impaired cytokine
       regulation in AIDS. Twelve asymptomatic patients on antiretroviral
       therapy for at least 1 year and with CD4 cell counts between 100-300/mm3
       were randomized to receive adjuvanted formol-inactivated interferon
       alpha-2a (IFN alpha) and continue the current antiretroviral treatment,
       whatever it was, or to receive the adjuvant alone and the current
       antiretroviral treatment. All patients received 4 i.m. injections
       monthly, followed by booster injections every 3 months. Clinical status,
       immunology and virology were monitored. Immune response to vaccination
       was evaluated in term of antibody detection (ELISA) and serum anti-IFN
       alpha neutralizing capacity. Only local discomfort and transient fever
       were reported. All vaccines except one showed increased levels of
       anti-IFN alpha Abs and developed serum IFN alpha neutralizing capacity.
       Viral load did not increase in vaccinees while it remained unchanged or
       even increased in placebo-treated patients. None of them showed
       HIV-related symptoms and all had their CD4 cell counts stabilized over
       18 months, whereas 2 placebo-treated patients developed full-blow AIDS.
       In conclusion, anti-IFN alpha vaccine was safe and immunogenic. Stable
       clinical and immunological status over 18 months was observed in
       vaccinees coupled to increased serum IFN alpha neutralizing capacity.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY/IMMUNOLOGY/
       *THERAPY/VIROLOGY  Adjuvants, Immunologic/ADMINISTRATION & DOSAGE  Adult
       Antibody Formation  CD4 Lymphocyte Count  Disease Progression
       Evaluation Studies  Female  Human  HIV Seropositivity/*IMMUNOLOGY
       Interferon Alfa-2a/CHEMISTRY/*IMMUNOLOGY/*THERAPEUTIC USE  Male
       Neutralization Tests  Single-Blind Method  CLINICAL TRIAL  CLINICAL
       TRIAL, PHASE I  CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE  RANDOMIZED
       CONTROLLED TRIAL

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

