title: Anti-alpha interferon immunization: safety and immunogenicity in asymptomatic HIV positive patients at high risk of disease progression.
abstract: 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.
authors.affiliation: A. Bianchi Bonomi Hemophilia and Thrombosis Center, Institute of Internal Medicine, IRCCS Maggiore Hospital, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Gringeri
authors.forename: E
authors.initials: E
authors.lastname: Santagostino
authors.forename: P M
authors.initials: PM
authors.lastname: Mannucci
authors.forename: L
authors.initials: L
authors.lastname: Siracusano
authors.forename: A
authors.initials: A
authors.lastname: Marinoni
authors.forename: M
authors.initials: M
authors.lastname: Criscuolo
authors.forename: M
authors.initials: M
authors.lastname: Carcagno
authors.forename: L S
authors.initials: LS
authors.lastname: Fall
authors.forename: J P
authors.initials: JP
authors.lastname: M'Bika
authors.forename: B
authors.initials: B
authors.lastname: Bizzini
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000276:immunology / Q000628:therapy* / Q000821:virology; D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D000917:Antibody Formation; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D005069:Evaluation Studies as Topic; D005260:Female; D006679:HIV Seropositivity / Q000276:immunology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000737:chemistry / Q000276:immunology* / Q000627:therapeutic use*; D008297:Male; D009500:Neutralization Tests; D011994:Recombinant Proteins; D016037:Single-Blind Method
chemical_list: D000276:Adjuvants, Immunologic; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins