IJCM_365A: A prospective study on the safety and clinical efficacy of rabies monoclonal antibodies for post exposure prophylaxis in suspected animal exposures at the anti rabies clinic of KIMS Hospital and Research Centre, Bangalore

Abstract

Background: Rabies immunoglobulins will provide timely passive immunity after exposure to suspected rabid animals along with thorough wound wash and full course of anti-rabies vaccination. The products include human derived RIG (HRIG) and equine derived RIG (ERIG), both having certain constraints for usage. In contrast, monoclonal antibodies (mAbs) produced by recombinant technology, have shown superiority in availability, safety and purity. Therefore, RmAb are an alternative to RIG for passive immunity component of post exposure prophylaxis (PEP). Only two products i.e., RabiShield (single human mAb) & Twinrab (cocktail of two mAbs) have been merchandised in Indian market. WHO has recommended monitoring the clinical use and outcomes of RmAb products for rabies PEP Objective: To assess the safety and clinical efficacy of presently available rabies monoclonal antibodies for post exposure prophylaxis Methodology: All the patients with category III exposure visiting the study site and consenting for the study were included. The details pertaining to socio demographic profile, details of biting animal, characteristics of bite wound, wound wash, details of active & passive immunization and details of adverse events following PEP were collected using a case record form. All the study subjects were followed up for the occurrence of any delayed reactions and further upto six months to know the clinical efficacy of PEP. Results: The present study included 475 animal bite victims. Among them 41.2 % were children, 49.6% were adults and 9.01 % were elderly. The ADEs among Rabishield and TwinRab were 3.18 % & 2.12 % respectively and the difference among them were not statistically significant. ADEs among all the patients receiving both RmAbs were mild and subsided without any complications. All the study subjects were healthy and alive after six months after PEP confirming clinical efficacy. Conclusion: The presently available RmAbs are safe and clinically effective in preventing rabies in suspected exposures