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A randomized, placebo-controlled, blind anti-AIDS clinical trial: Safety and immunogenicity of a specific anti-IFNα immunization
Authors
Ammar Achour
Françoise Hélène F. Barré-Sinoussi
+23 more
Bernard Bizzini
Arsène Burny
Anna Maria A. Buzzi
Vida Chams
Charles Chany
Marcelo Criscuolo
D. Cultraro
Annie David
Marie Christine Defer
LS Fall
Michael Feldman
Michéle Fouchard
Alessandro Gringeri
Laurent Guillemot
Philippe Hermans
Abderrahim Lachgar
H. Le Coq
Pier Mannuccio M P.M. Mannucci
Odile Picard
Elena Santagostino
Filippo Tradati
Daniel Zagury
Jean-François Zagury
Publication date
1 January 1994
Publisher
Abstract
HIV-induced cytokine dysregulation, incluCling overproduction of the antiproliferative and cytolytic IFNα cytokine, represents a major component of the immune disorders characterizing AIDS. To block the overproduction of IFNα we designed an AIDS vaccine combination which included both an anti-HIV and/or an anti-IFNα immunization. The safety and immunogenicity of this multicomponent vaccine were tested in mice, Cercopithecus, two HIV noninfected individuals, and six HIV-1 seropositive immunocompromised patients enrolled in a 1-year open clinical trial. We now report the result of a 9-month short-term randomized, blind, placebo-controlled clinical trial (Phase I/II) performed in HIV-1 patients (22 individuals) to confirm safety/tolerance of the anti-IFNα vaccine and its immunogenicity and to evaluate whether the complex vaccine initially used could be simplified by removal of HIV compo-nent(s). Three groups of patients received inactivated IFNα (i-IFNα) associated with the immunomodulator P40 with HIV-1 antigens (groups B and C) or without (group A), and one group (D) was placebo. The clinical follow-up documented among those receiving i-IFNα showed that none developed AIDS and/or required antiretroviral chemotherapy. Viral load did not increase and CD4 cell count as well as cell-mediated immunity (CMI) stabilized or even significantly increased in group A. Immunogenicity of the preparations was determined by a positive delayed-type hypersensitivity (DTH) reaction to i-IFNα and the presence of serum antibodies to i-IFNα and to HIV-1 peptides, occurring only in treated patients. As previously planned, based on these safety data, the trial has been extended for an additional year and all patients were switched to protocol A (i-IFNα + P40). This second period of the trial, now open and ongoing, should allow us to evaluate further the innocuity of the i-IFNα preparation and whether anti-IFNα vaccine could provide a long-lasting CD4 cell count as well as CMI stabilization. © 1994 Raven Press Ltd. New York.SCOPUS: ar.jinfo:eu-repo/semantics/publishe
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Last time updated on 23/02/2017