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

PURPOSE: Rabies immunoglobulin (RIG) will offer immediate passive protection after exposure to suspected rabid animals. These include human RIG and equine RIG, both having constraints for usage. Recombinant technology produced monoclonal antibodies (mAbs) have demonstrated greater availability and safety as a substitute for RIG in post-exposure prophylaxis (PEP). Presently 2 mAb products have been merchandised; World Health Organization has advised monitoring of both the rabies monoclonal antibodies (RmAb) products' in clinical use. To assess the safety and clinical effectiveness of RmAbs for PEP in category III animal exposures.

MATERIALS AND

METHODS

All patients with category III exposure who visited the study site and gave their consent were included. A case record form was used to gather information on the sociodemographic profile, bite wound features, PEP given, and specifics of adverse events that occurred after PEP. For a further 6 months, all the research participants were monitored to determine the clinical effectiveness of PEP.

RESULTS

The present study included 475 animal bite victims. Among them 41.2% were children, 49.7% were adults and 9.1% were elderly. The adverse events (AEs) among single mAb and cocktail of 2 mAbs were 8.7% and 8.1%, respectively. All the patients who received either of the RmAb experienced mild AEs that resolved on their own or by symptomatic treatment, without any complications. All the trial participants were alive after 6 months following PEP, indicating therapeutic success.

CONCLUSION

The presently available RmAbs are safe and clinically effective in preventing rabies in suspected exposures.