Evaluation of monoclonal antibodies to human immunodeficiency virus type 1 primary isolates by neutralization assays: Performance criteria for selecting candidate antibodies for clinical trials
Evaluation of monoclonal antibodies to human immunodeficiency virus type 1 primary isolates by neutralization assays: Performance criteria for selecting candidate antibodies for clinical trials
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DOI：
10.1086/516443
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发表时间：
1997-05-01
影响因子：
6.4
通讯作者：
Katinger, H
中科院分区：
文献类型：
--
作者：
DSouza, MP;Livnat, D;Katinger, H
组织了一项合作研究，以确定可能广泛和有效地中和一组人类免疫缺陷病毒1型(HIV-1)低传代成人和儿童外周血单个核细胞中的初级分离株的单抗(MAb)，五个实验室评估了一个由七个人单抗组成的编码小组，该小组针对HIV-1B亚型包膜V3、CD4结合区、gp41和其他构象敏感决定因素。每个实验室都测量了单抗对实验室分离株HIVMN和一组9个B亚型初级分离株的中和活性。如果抗体能够在低于或等于25微克/毫升的浓度下中和9个主要分离株中的至少一半，达到90%的病毒抑制率，则被归类为适合于未来临床研究的候选抗体。这项研究确定了三种符合规定的性能标准的单抗：IgG1b12、2G12和2F5。这些结果可能为单独或联合检测三种单抗的临床疗效提供理论依据。
A collaborative study was organized to identify monoclonal antibodies (MAbs) that may be broadly and potently neutralizing for a panel of human immunodeficiency virus type 1 (HIV-1) low-passaged adult and pediatric primary isolates in peripheral blood mononuclear cells, Five laboratories evaluated a coded panel of seven human MAbs to HIV-1 subtype B envelope V3, CD4 binding region, gp41, and other conformationally sensitive determinants. Each laboratory measured neutralizing activity of the MAbs against the laboratory isolate HIVMN and a panel of 9 subtype B primary isolates. Antibodies were classified as suitable candidates for future clinical studies if they could neutralize at least half of the 9 primary isolates at a concentration of less than or equal to 25 mu g/mL for 90% viral inhibition. The study identified three MAbs that met stated performance criteria: IgG1b12, 2G12, and 2F5. These results may provide a rationale for examining the clinical efficacy, either singly or in combination, of the three MAbs.