Survey of Human Rabies Immune Globulin Safety in Children

NCT05382650 | Terminated FDA Drug

• 1 other identifier: PRO00028137
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

Conditions

Rabies; Rabies Human; Rabies Virus Infection; Pediatrics

Keywords

Pediatrics; Rabies post-exposure prophylaxis; Rabies PEP; Rabies immune globulin; Rabies IG; Adverse events

Outcome Measures

Primary Outcomes (1)

• Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration

  Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration

  Within 2 days of HRIG 300 IU/mL administration

Secondary Outcomes (4)

• Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration

  Within 10 days of HRIG 300 IU/mL administration

• Cumulative incidence of all local and systemic AEs within 30 days of HRIG 300 IU/mL administration

  Within 30 days of HRIG 300 IU/mL administration

• Cumulative incidence of all local and systemic serious adverse events (SAEs) within 30 days of HRIG 300 IU/mL administration

  Within 30 days of HRIG 300 IU/mL administration

• Type and severity of individual local and systemic AEs detected within 30 days of HRIG 300 IU/mL administration

  Within 30 days of HRIG 300 IU/mL administration

Interventions

Human rabies immune globulin 300 IU/mL BIOLOGICAL

All participants in this single-cohort observational study will receive human rabies immune globulin 300 IU/mL at a dose of 20 IU/kg per standard of care.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who received HRIG 300 IU/mL as part of routine medical care for rabies PEP during an ED visit in up to 5 study sites in the United States

You may qualify if:

• Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
• Aged ≤17 years

You may not qualify if:

• HRIG 300 IU/mL dose given is \<18 IU/kg or \>22 IU/kg
• Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure
• Patient has a history of rabies vaccine or rabies immune globulin administration
• Legally authorized representative (parent) does not speak English if patient is \<7 years old
• Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old
• Inability to obtain consent
• More than 3 days passed since HRIG 300 IU/mL administration prior to screen
• Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration
• Legally authorized representative (parent) and/or patient declined participation
• Administration sites for HRIG are unknown

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (2)

Houston Methodist

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, Meltzer MI, Dhankhar P, Vaidya SA, Jenkins SR, Sun B, Hull HF; Advisory Committee on Immunization Practices Centers for Disease Control and Prevention (CDC). Human rabies prevention--United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008 May 23;57(RR-3):1-28.

  PMID: 18496505 BACKGROUND

• Hwang GS, Rizk E, Bui LN, Iso T, Sartain EI, Tran AT, Swan JT. Adherence to guideline recommendations for human rabies immune globulin patient selection, dosing, timing, and anatomical site of administration in rabies postexposure prophylaxis. Hum Vaccin Immunother. 2020;16(1):51-60. doi: 10.1080/21645515.2019.1632680. Epub 2019 Aug 1.

  PMID: 31210569 BACKGROUND

• Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 2018.

  PMID: 29983597 BACKGROUND

Related Links

• Kamada Ltd., Kedrion Biopharma. U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG). Accessed April 11, 2022
• Identifier NCT02912845, Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies. National Library of Medicine (US); 2019. Accessed April 11, 2022
• Centers for Disease Control and Prevention. Rabies in the United States: Protecting Public Health. Accessed November 11, 2025
• World Health Organization. Rabies. Accessed April 11, 2022
• HyperRab® \[rabies immune globulin (human)\] \[package insert\]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2021. Accessed April 11, 2022

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Michael Sirimaturos, PharmD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative Specialist - System Critical Care Services Leader

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 19, 2022
• Study Start: February 22, 2023
• Primary Completion: September 17, 2025
• Study Completion: October 15, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)