Schedel I, Sutor G C, Hunsmann G, Jurkiewicz E
Department of Internal Medicine, Division of Gastroenterology, Hannover Medical School, Germany.
Vaccine. 1999 Apr 9;17(15-16):1837-45. doi: 10.1016/s0264-410x(98)00483-6.
A clinical phase II trial of postinfectional idiotype vaccination was performed in early stage HIV + volunteers. The mAb 13B8.2 is directed against the CDR3-homologous CD4/D1 region implicated in HIV-gp120 binding. We have previously shown that this mAb induces HIV-gp120 cross-reactive immunity. In addition, the mAb 13B8.2 was well tolerated in a clinical phase-Ia trial. In this phase-II trial, 158 patients with 350-500 CD4+ cells/microl blood were randomised to receive either 1.2 mg of alum-precipitated mAb 13B8.2 or placebo. The mAb was well tolerated evoking predominantly local side effects. Multivariant analysis of clinical study endpoints demonstrated a significant response in the verum group (intend-to-treat analysis). Titres of HIV-1 neutralisation in vitro were raised along with HIV/gp120 antigen binding titres. Our data indicate that patients treated with the idiotype vaccine will produce an augmented specific anti-viral immune response. The vaccine might thus have a positive impact on the course of HIV disease.
在早期HIV阳性志愿者中开展了感染后独特型疫苗的II期临床试验。单克隆抗体13B8.2针对与HIV - gp120结合相关的CDR3同源CD4/D1区域。我们之前已表明该单克隆抗体可诱导HIV - gp120交叉反应性免疫。此外，单克隆抗体13B8.2在I期临床试验中耐受性良好。在该II期试验中，将158例每微升血液中CD4 +细胞数为350 - 500的患者随机分组，分别接受1.2毫克明矾沉淀的单克隆抗体13B8.2或安慰剂。该单克隆抗体耐受性良好，主要引起局部副作用。临床研究终点的多变量分析显示，在试验组（意向性分析）中有显著反应。体外HIV - 1中和抗体滴度以及HIV/gp120抗原结合抗体滴度均升高。我们的数据表明，接受独特型疫苗治疗的患者将产生增强的特异性抗病毒免疫反应。因此，该疫苗可能会对HIV疾病进程产生积极影响。
