Gringeri A, Santagostino E, Muça-Perja M, Mannucci P M, Zagury J F, Bizzini B, Lachgar A, Carcagno M, Rappaport J, Criscuolo M, Blattner W, Burny A, Gallo R C, Zagury D
Hemophilia and Thrombosis Center Angelo Bianchi Bonomi, IRCCS Maggiore Hospital, Milan, Italy.
J Hum Virol. 1998 May-Jun;1(4):293-8.
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.
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).
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.
These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.
为了对抗HIV-1毒素细胞外Tat对未感染免疫细胞的有害影响，我们开发了一种使用灭活但具有免疫原性的Tat（Tat类毒素）的新型抗HIV-1疫苗策略。已在血清反应阳性患者中对Tat类毒素的安全性和免疫原性进行了检测。
在14名HIV-1感染的无症状但生物学上免疫功能低下的个体（500 - 200个CD4 +细胞/mm3）中进行了在赛比克Isa 51油佐剂中测试Tat类毒素制剂的I期疫苗临床试验。
在多达8次注射后，未观察到临床缺陷。所有患者均表现出对Tat的抗体（Ab）反应，并且通过体内皮肤试验和体外T细胞增殖评估，一些患者具有细胞介导的免疫（CMI）。
这些结果为Tat类毒素疫苗接种在HIV-1感染个体中的安全性和效力提供了初步证据。
