Rabies is a severe infectious disease caused by the rabies virus, which seriously damages the central nervous system. Once it occurs, the fatality rate is close to 100%. The World Health Organization's position paper on rabies vaccines recognizes that rabies immunoglobulin (RIG) should be used for post-exposure prophylaxis (PEP) in all category Ⅲ exposure for the first time, as well as in category Ⅱ exposure that suffer from severe immune deficiency, long-term massive use of immunosuppressants, and head and face exposure. The anti-rabies virus monoclonal antibody has high purity and specific activity, can be produced on a sustainable scale, and has no risk of blood source virus contamination. Preclinical pharmacodynamic studies and clinical trial results of the anti-rabies virus monoclonal antibody preparation have confirmed that the preparation has a broad-spectrum neutralization effect on the rabies virus. Additionally, its combined application with the vaccine has little impact on the active immunity of the vaccine. Therefore, the anti-rabies virus monoclonal antibody preparation shows great potential for clinical application in PEP.
狂犬病是由狂犬病病毒感染引起、严重侵害中枢神经系统的烈性传染病，一旦发病，病死率接近100%。WHO狂犬病疫苗立场文件认定所有首次暴露的Ⅲ级暴露者以及患有严重免疫缺陷、长期大量使用免疫抑制剂、头面部暴露的Ⅱ级暴露者均应在狂犬病暴露后预防处置时使用被动免疫制剂。抗狂犬病病毒单克隆抗体纯度高、比活性高，可持续规模化生产，且无血源病毒污染风险。对抗狂犬病病毒单克隆抗体制剂的临床前药效学研究和临床人体试验结果证实，该制剂对狂犬病病毒具有广谱中和作用，与疫苗联合应用对疫苗的主动免疫影响小，在狂犬病暴露后预防处置中具有良好的临床应用前景。.