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Updated: Nov 18, 2025
Enhanced Rabies Surveillance Using a Direct Rapid Immunohistochemical Test
Published on: April 30, 2019
Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure
Nicholas Hobart-Porter1, Michal Stein2, Naveh Toh2
1Department of Pediatrics, Division of Pediatric Emergency Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Insights
Human rabies immunoglobulin (HRIG150) is safe and effective for children receiving post-exposure prophylaxis (PEP) after potential rabies exposure. This study provides crucial pediatric safety and efficacy data for HRIG150 in the US.
Area of Science:
- Virology
- Immunology
- Pediatric Medicine
Background:
- Rabies is a fatal zoonotic disease with significant global impact.
- Post-exposure prophylaxis (PEP) is critical for preventing rabies after exposure.
- Limited pediatric data exists for rabies post-exposure prophylaxis.
Purpose of the Study:
- To evaluate the safety, efficacy, and immunogenicity of human rabies immunoglobulin (HRIG150) in pediatric patients (<17 years) receiving PEP.
- To establish the first pediatric safety and efficacy profile for HRIG in the United States.
Main Methods:
- A prospective, open-label, single-arm clinical trial involving 30 pediatric participants.
- Participants received HRIG150 (KEDRAB 150 IU/mL) infiltrated into wounds and intramuscularly, along with a 4-dose rabies vaccine series.
- Safety was monitored for 84 days; rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14.
Main Results:
- No serious adverse events, rabies infections, or deaths were reported.
- 93.3% of participants achieved protective RVNA levels (≥0.5 IU/mL) by day 14.
- 70.0% experienced mild, treatment-emergent adverse events, with 40.0% considered treatment-related.
Conclusions:
- HRIG150 is well-tolerated and effective as part of PEP in pediatric patients.
- This study provides essential data on the pediatric safety and efficacy of HRIG in the US.
- HRIG150 represents a valuable option for rabies prevention in children.
Abstract:
Rabies is a deadly viral zoonosis with global disease burden. Following exposure to a rabid animal, post-exposure prophylaxis (PEP) is the standard of care for unvaccinated persons. Despite the large proportion of pediatric cases, limited safety and efficacy data exist for use in pediatric patients. We report the safety, efficacy, and immunogenicity of a phase 4, prospective, 2-center, open-label, single-arm clinical trial evaluating human rabies immunoglobulin (HRIG150; KEDRAB 150 IU/mL) as part of PEP in patients (aged <17) with suspected or confirmed rabies exposure, where PEP was indicated. Thirty participants received 20 IU/kg HRIG150 infiltrated into the detectable wound site(s), with any remainder injected intramuscularly, concomitantly with the first of a 4-dose series (days 0, 3, 7, and 14) of rabies vaccine. Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration. Participant safety was monitored for 84 days. No serious adverse events, rabies infections, or deaths were recorded. Twenty-one participants (70.0%) experienced a total of 57 treatment-emergent adverse events (TEAEs) within 14 days following administration. Twelve participants (40.0%) experienced a total of 13 adverse events deemed treatment related. All TEAEs were mild in severity. On day 14, 28 participants (93.3%) had RVNA levels of ≥0.5 IU/mL (mean±standard deviation: 18.89 ± 31.61). These results demonstrate that HRIG150 is well tolerated and effective in pediatric patients as a component of PEP. To the authors' knowledge, this study is the first to establish pediatric safety and efficacy of HRIG in the US.
