A Gringeri, E Santagostino, M Muça-Perja, P M Mannucci, J F Zagury, B Bizzini, A Lachgar, M Carcagno, J Rappaport, M Criscuolo, W Blattner, A Burny, R C Gallo, D Zagury
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引用次数: 0
摘要
目的:为了对抗HIV-1毒素细胞外Tat对未感染免疫细胞的有害作用,我们开发了一种新的抗HIV-1疫苗策略,使用灭活但具有免疫原性的Tat (Tat类毒素)。该类毒素已在血清阳性患者中进行了安全性和免疫原性试验。方法:对14例无症状但生物免疫功能低下(500-200 CD4+细胞/mm3)的hiv -1感染患者进行了Seppic Isa 51油佐剂中Tat类毒素制剂的I期疫苗临床试验。结果:经8次注射,无临床缺陷。所有患者对Tat均表现出抗体(Ab)应答,部分患者体内皮肤试验和体外t细胞增殖评价为细胞介导免疫(CMI)。结论:这些结果为hiv -1感染者接种Tat类毒素疫苗的安全性和效力提供了初步证据。
Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients.
Objectives: 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.
Method: 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.
Conclusion: These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.