Long term safety and efficacy of rabies monoclonal antibody in post-exposure prophylaxis

1. The rate of adverse events and seroresponse was similar between groups.

2. There were no incidents of rabies development in either group after 1-year.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Rabies is a universally fatal disease, and rabies monoclonal antibody (RmAb) was approved in 2016 for passive prophylaxis. This randomized controlled trial aimed to compare the safety, immune response, and efficacy of the RmAb plus purified Vero cell rabies vaccine (PVRV) regimen with the equine rabies immunoglobulin (ERIG) plus PVRV regimen in patients with rabies exposures. The primary outcome of this study was the incidence of treatment-related serious adverse events within one year, while key secondary outcome was the mean concentration of rabies virus neutralizing antibodies at specified time points. According to study results, RmAb plus PVRV was safe, well-tolerated, immunogenic, and effective, with no rabies cases reported during one year of follow-up. Although this study was well done, it was limited by its open-label design, which could introduce bias in outcome reporting.

Click to read the study in The Lancet

Relevant Reading: Survival after Treatment of Rabies with Induction of Coma

In-depth [randomized controlled trial]: Between Aug 21, 2019, and Mar 31, 2022, 4062 patients were assessed for eligibility at 15 tertiary care hospitals in India. Included were patients ≥ 2 years with WHO category 3 rabies exposure from a suspected rabid animal within 72 hours of enrolment. Altogether, 4059 patients (2996 in RmAb plus PVRV and 998 in ERIG plus PVRV) were included in the final analysis. The primary outcome of treatment-related serious adverse events within one year showed no causally related serious events in the RmAb group and one in the ERIG group. The secondary outcome of rabies virus neutralizing antibody levels on day 14 demonstrated slightly higher mean concentrations in the RmAb group (16.05 IU/mL vs. 13.48 IU/mL). Overall, findings from this study suggest that RmAb plus PVRV is a safe, well-tolerated, and effective post-exposure prophylaxis option for rabies.

Image: PD

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