Shankaraiah Ravish Haradanahalli, Masthi N R Ramesh, Poornima M K, Kiruffi Vinitha, Sowmyashree S, Dutta Trayambak, Mahajan Manish, Desai Samir
Department of Community Medicine, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.
Zydus Lifesciences Ltd., Ahmedabad, Gujarat, India.
J Glob Infect Dis. 2024 Oct 18;16(4):140-144. doi: 10.4103/jgid.jgid_71_24. eCollection 2024 Oct-Dec.
Rabies monoclonal antibody (mAb) is a life-saving immune-biological for postexposure prophylaxis (PEP) in all Category III animal exposures. A novel cocktail of mAbs derived using recombinant DNA technology is presently available for usage. The WHO recommends monitoring the clinical use and outcomes of mAb products.
An open-label, postmarketing study was conducted at the anti-rabies clinic in the southern part of India. PEP was provided to all the study participants per the national guidelines. All the subjects were assessed for any adverse events (AEs) following PEP up to 35 days; if any, were treated free of cost at the study center.
The present study included 309 subjects across all age groups, 59.2% were adults, 33.3% of children, and 7.5% elderly. Majority of the patients were exposed to dogs (89.6%) and most of them had lacerations (86.3%) in different parts of their body. A total of 19 (6.2%) AEs were reported. All the AEs were local reactions, namely pain (2.6%), erythema (1.4%), tenderness (1%), induration (0.6%), and swelling (0.6%). All reported AEs were mild (Grade 1 severity) and resolved completely with symptomatic treatment.
The novel cocktail of mAbs was safe for PEP in Category III animal exposures across all the age groups and supports its continued and improved usage for Universal Health Coverage to prevent rabies.
狂犬病单克隆抗体（mAb）是用于所有III类动物暴露后预防（PEP）的一种挽救生命的免疫生物制品。目前有一种使用重组DNA技术衍生的新型单克隆抗体鸡尾酒制剂可供使用。世界卫生组织建议监测单克隆抗体产品的临床使用情况和结果。
在印度南部的抗狂犬病诊所进行了一项开放标签的上市后研究。根据国家指南为所有研究参与者提供暴露后预防。对所有受试者在暴露后预防后长达35天的任何不良事件（AE）进行评估；如有任何不良事件，在研究中心免费治疗。
本研究纳入了所有年龄组的309名受试者，其中59.2%为成年人，33.3%为儿童，7.5%为老年人。大多数患者被狗咬伤（89.6%），其中大多数人身体不同部位有撕裂伤（86.3%）。共报告了19例（6.2%）不良事件。所有不良事件均为局部反应，即疼痛（2.6%）、红斑（1.4%）、压痛（1%）、硬结（0.6%）和肿胀（0.6%）。所有报告的不良事件均为轻度（1级严重程度），经对症治疗后完全缓解。
这种新型单克隆抗体鸡尾酒制剂在所有年龄组的III类动物暴露后预防中是安全的，支持其继续并改进用于全民健康覆盖以预防狂犬病。
