Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients.
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.
Gringeri
A
A
Hemophilia and Thrombosis Center Angelo Bianchi Bonomi, IRCCS Maggiore Hospital, Milan, Italy. hemophilia_ctr@polic.cilea.it
Santagostino
E
E
Muça-Perja
M
M
Mannucci
P M
PM
Zagury
J F
JF
Bizzini
B
B
Lachgar
A
A
Carcagno
M
M
Rappaport
J
J
Criscuolo
M
M
Blattner
W
W
Burny
A
A
Gallo
R C
RC
Zagury
D
D
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
D016915:AIDS Vaccines; D015696:Gene Products, tat; D015483:HIV Antibodies; D016655:HIV Core Protein p24; D054322:tat Gene Products, Human Immunodeficiency Virus