Safety and clinical efficacy of human rabies immunoglobulin in post exposure prophylaxis for category III animal exposures

Abstract

The human rabies immunoglobulin (HRIG) is a life-saving immune biological essential for all category III animal exposures. It provides neutralizing antibodies at the site of exposure until the body can produce vaccine-mediated antibodies. We conducted this study to determine the safety and clinical efficacy of an HRIG being used presently for post-exposure prophylaxis (PEP) and to strengthen the existing evidence for its further usage. We conducted a prospective cohort study in 123 subjects with category III animal exposures at the KIMS Hospital and Research Center, Bangalore, India. Post-exposure prophylaxis (PEP) with wound toilet, a single application of HRIG, and a full course of anti-rabies vaccination were provided to all the study subjects. The volume of HRIG was calculated according to the body weight, and all the wounds were infiltrated as was anatomically feasible. All the study subjects were followed up for immediate and delayed adverse events (AE), both local and systemic. Subsequently, all the subjects were followed up for 6 months to demonstrate the clinical efficacy of PEP. The incidence of AEs was 11.4% including local pain, erythema, itching, headache, body ache, fever, and malaise. All AEs were mild and subsided without any complications. All the study subjects were healthy and alive after 6 months following the administration of HRIG, along with a full course of anti-rabies vaccine. Our study provides evidence of safety and clinical efficacy of HRIG for category III animal exposures and supports its continued usage.

Ptosis Caused by Local Injection of Human Rabies Immunoglobulin

“…It can also simplify vaccination, improve compliance, and reduce the cost of rabies vaccination 2 . In addition, Haradanhalli et al’s 4 study provides strong evidence for the safety and clinical efficacy of HRIG in category III animal exposures. According to relevant data reports, the application of HRIG within 1 week of receiving the rabies vaccine will not affect the immune effect of the vaccine to produce protective antibodies, which can provide valuable time for active immunization of the vaccine 5…”

Demographic, temporal, and spatial analysis of human rabid animal bite cases in Mymensingh District, Bangladesh

“…Human Rabies Immunoglobulin (HRIG) is a life-saving immune biological, particularly necessary for individuals exposed to category 3 animal bites. These bites are characterized by severe wounds with a high risk of rabies transmission, necessitating immediate administration of HRIG (31). HRIG provides immediate protection by supplying neutralizing antibodies.…”

“…HRIG provides immediate protection by supplying neutralizing antibodies. Previous studies have shown that these antibodies play a crucial role in bridging the gap until the individual’s immune system can generate vaccine-mediated antibodies (31).…”

Post-Marketing Surveillance of the World’s First Novel Cocktail of Rabies Monoclonal Antibodies: TwinRab™ in Real \-World Setting

“…[ 4 ] A combination of anti-rabies immunoglobulin and vaccine has become the standard World Health Organization (WHO) treatment for humans with suspected exposure to rabies virus. [ 5 ] The advances in passive immunoprophylaxis, most notably shift from recommended polyclonal human or equine immunoglobulins to monoclonal antibody therapies. [ 6 ] In 2002, the Strategic Advisory Group of Experts (SAGE) of the WHO recommended that cocktails containing at least two mAbs binding to non-overlapping epitopes of rabies virus G glycoprotein should be encouraged as an alternative to eRIG or hRIG as mAbs can be produced with standardized quality in large quantities, do not use animals in the production process, and have higher effectiveness and reduced risk of adverse events.…”