title: Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients.
abstract: OBJECTIVE
  To antagonize the deleterious effects of the HIV-1 toxin extracellular Tat on uninfected immune cells, we developed a new strategy of anti-HIV-1 vaccine using an inactivated but immunogenic Tat (Tat toxoid). Tat toxoid has been assayed for safety and immunogenicity in seropositive patients.
  
  
  METHODS
  The phase I vaccine clinical trial testing Tat toxoid preparation in Seppic Isa 51 oil adjuvant was performed on 14 HIV-1-infected asymptomatic although biologically immunocompromised individuals (500-200 CD4+ cells/mm3).
  
  
  RESULTS
  Following as many as 8 injections, no clinical defects were observed. All patients exhibited an antibody (Ab) response to Tat, and some had cell-mediated immunity (CMI) as evaluated by skin test in vivo and T-cell proliferation in vitro.
  
  
  CONCLUSIONS
  These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.
authors: Hemophilia and Thrombosis Center Angelo Bianchi Bonomi, IRCCS Maggiore Hospital, Milan, Italy. hemophilia_ctr@polic.cilea.it
authors: A
authors: A
authors: Gringeri
authors: E
authors: E
authors: Santagostino
authors: M
authors: M
authors: Muça-Perja
authors: P M
authors: PM
authors: Mannucci
authors: J F
authors: JF
authors: Zagury
authors: B
authors: B
authors: Bizzini
authors: A
authors: A
authors: Lachgar
authors: M
authors: M
authors: Carcagno
authors: J
authors: J
authors: Rappaport
authors: M
authors: M
authors: Criscuolo
authors: W
authors: W
authors: Blattner
authors: A
authors: A
authors: Burny
authors: R C
authors: RC
authors: Gallo
authors: D
authors: D
authors: Zagury
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology* / Q000628:therapy / Q000821:virology; D000328:Adult; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D015696:Gene Products, tat / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use; D015483:HIV Antibodies / Q000276:immunology; D016655:HIV Core Protein p24 / Q000276:immunology; D015497:HIV-1 / Q000737:chemistry* / Q000276:immunology; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D010865:Pilot Projects; D054322:tat Gene Products, Human Immunodeficiency Virus
chemical_list: D016915:AIDS Vaccines; D015696:Gene Products, tat; D015483:HIV Antibodies; D016655:HIV Core Protein p24; D054322:tat Gene Products, Human Immunodeficiency Virus