Safety and tolerability of a novel monoclonal antibody cocktail for rabies post-exposure prophylaxis

Abstract

Rabies is one of the most lethal viral zoonoses, particularly in low- and middle-income countries where access to post-exposure prophylaxis is limited. Conventional post-exposure prophylaxis relies on rabies immune globulin and vaccination. This study evaluated the safety of a monoclonal antibody cocktail, docaravimab and miromavimab, in 159 patients with severe animal bites. The cocktail was administered locally to 94.3 percent of participants and both locally and systemically to 5.7 percent. Adverse events were reported in 10.7 percent of cases, predominantly mild and local, with no systemic or severe reactions observed. No cases of rabies occurred during six months of follow-up. These findings suggest that the monoclonal antibody cocktail has a favorable safety profile, potentially serving as a viable alternative to traditional rabies immune globulin in post-exposure prophylaxis.

Fig. 1. Distribution of Biting Animals by Age Group.

This bar chart illustrates the percentage of animal bites across different age groups (< 5, 5-17, 18-58, ≥ 60) categorized by biting animal types: Stray Dog, Pet Dog, Cat, and Monkey. The highest proportion of bites in the 18-58 age group comes from stray dogs (32%), followed by pet dogs (24.5%). In the 5-17 age group, stray and pet dogs also account for most bites (11.9% and 12.5%, respectively). Cats and monkeys contribute minimally across all age groups, with minor percentages of bites, particularly in the younger and older populations.

Fig. 2. Distribution of anti-rabies vaccine usage and cocktail mAb site of administration across different age groups.

The bars represent the percentage of individuals in each age group receiving the PCECV and PVRV vaccines, as well as the site of cocktail mAb administration (Local and Local & Systemic). The dashed line indicates the mean dosage of cocktail mAb (in IU) infiltrated into the wound, with the corresponding values displayed for each age group.

Fig. 3. Flowchart of the Study Design and Treatment Pathways for Rabies Post-Exposure Prophylaxis.

This flowchart illustrates the inclusion and exclusion criteria for study participants and outlines the post-exposure prophylaxis protocol, including wound management, vaccination, and monoclonal antibody administration.