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1996-02-26
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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).