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首页> 外文期刊>Vaccine >First administration to humans of a monoclonal antibody cocktail against rabies virus: Safety, tolerability, and neutralizing activity
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First administration to humans of a monoclonal antibody cocktail against rabies virus: Safety, tolerability, and neutralizing activity

机译：首次向人类施用抗狂犬病病毒的单克隆抗体混合物：安全性，耐受性和中和活性

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摘要

Immediate passive immune prophylaxis as part of rabies post-exposure prophylaxis (PEP) often cannot be provided due to limited availability of human or equine rabies immunoglobulin (HRIG and ERIG, respectively). We report first clinical data from two phase I studies evaluating a monoclonal antibody cocktail CL184 against rabies. The studies included healthy adult subjects in the USA and India and involved two parts. First, subjects received a single intramuscular dose of CL184 or placebo in a double blind, randomized, dose-escalation trial. Second, open-label CL184 (20 IU/kg) was co-administered with rabies vaccine. Safety was the primary objective and rabies virus neutralizing activity (RVNA) was investigated as efficacy parameter. Pain at the CL184 injection site was reported by less than 40% of subjects; no fever or local induration, redness or swelling was observed. RVNA was detectable from day 1 to day 21 after a single dose of CL184 20 or 40 IU/kg. All subjects had adequate (>0.5 IU/mL) RVNA levels from day 14 onwards when combined with rabies vaccine. CL184 appears promising as an alternative to RIG in PEP.
机译：由于人或马狂犬病免疫球蛋白（分别为HRIG和ERIG）的可用性有限，通常无法提供作为狂犬病暴露后预防（PEP）一部分的立即被动免疫预防。我们报告了来自第一期临床研究的第一批临床数据，该研究评估了抗狂犬病单克隆抗体鸡尾酒CL184。该研究包括美国和印度的健康成人受试者，涉及两个部分。首先，在双盲，随机，剂量递增试验中，受试者接受肌内单剂量的CL184或安慰剂。其次，将开放标签的CL184（20 IU / kg）与狂犬病疫苗联合使用。安全是主要目标，研究狂犬病毒中和活​​性（RVNA）作为功效参数。不到40％的受试者报告了CL184注射部位的疼痛。没有观察到发烧或局部硬结，发红或肿胀。单次服用CL184 20或40 IU / kg后，从第1天到第21天可检测到RVNA。从第14天开始，与狂犬病疫苗联合使用时，所有受试者的RVNA水平均足够（> 0.5 IU / mL）。 CL184有望在PEP中替代RIG。

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