Survey of Human Rabies Immune Globulin Safety in Children

NCT ID: NCT05382650

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2025-10-15

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.

Detailed Description

BACKGROUND: Rabies PEP consists of thorough wound cleansing, administration of HRIG 20 IU/kg body weight, and 4 to 5 doses of rabies vaccine. The safety of HRIG 300 IU/mL has been confirmed only for adult patients. Although the safety of HRIG 300 IU/mL in the pediatric population has not been fully established, there is no age limit on the FDA approved indication for HRIG 300 IU/mL, and it is routinely administered to pediatric patients as standard of care in the United States.

STUDY DESIGN: This observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of HRIG 300 IU/mL among pediatric patients (age ≤17 years) at up to 5 study sites in the United States. Safety data will be collected using surveys and chart review of the health record. All participants will receive HRIG 300 IU/mL per standard of care prior to joining this study. The day of HRIG 300 IU/mL administration will be defined as day 0. The study will conduct Survey 1 on day 2 and Survey 2 on day 10 to collect information on adverse events (AEs). Investigators will review the electronic health record on day 30 to collect additional information on AEs. If a serious adverse event is detected during Survey 1, Survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct Survey 3 on day 30.

Conditions

Rabies; Rabies Human; Rabies Virus Infection; Pediatrics

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Human rabies immune globulin 300 IU/mL

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit

2. Aged ≤17 years

Exclusion Criteria

1. HRIG 300 IU/mL dose given is <18 IU/kg or >22 IU/kg

2. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure

3. Patient has a history of rabies vaccine or rabies immune globulin administration

4. Legally authorized representative (parent) does not speak English if patient is <7 years old

5. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old

6. Inability to obtain consent

1. More than 3 days passed since HRIG 300 IU/mL administration prior to screen

2. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration

3. Legally authorized representative (parent) and/or patient declined participation

7. Administration sites for HRIG are unknown

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Michael Sirimaturos

Administrative Specialist - System Critical Care Services Leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Sirimaturos, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18496505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31210569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29983597 (View on PubMed)

Related Links

https://www.globenewswire.com/news-release/2020/08/19/2080546/0/en/Kamada-and-Kedrion-Biopharma-Announce-Results-of-First-and-Only-U-S-Post-Marketing-Pediatric-Trial-of-a-Human-Rabies-Immune-Globulin-HRIG-The-Study-Met-Its-Primary-Objective.html

Kamada Ltd., Kedrion Biopharma. U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG). Accessed April 11, 2022

https://ClinicalTrials.gov/show/NCT02912845

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

https://www.cdc.gov/rabies/php/protecting-public-health/index.html

Centers for Disease Control and Prevention. Rabies in the United States: Protecting Public Health. Accessed November 11, 2025

https://www.who.int/en/news-room/fact-sheets/detail/rabies

World Health Organization. Rabies. Accessed April 11, 2022

https://www.hyperrab.com/documents/2533658/2533707/Prescribing+Information+HyperRAB+300.pdf/813095ad-a0b7-48fd-b3a8-c531d418e148?t=1617208717698

HyperRab® \[rabies immune globulin (human)\] \[package insert\]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2021. Accessed April 11, 2022

Other Identifiers

PRO00028137

Identifier Type: -

Identifier Source: org_study_id