Clinical trial NCT05382650: Survey of Human Rabies Immune Globulin Safety in Children
Official title: Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rabies
Rabies Human
Rabies Virus Infection
Pediatrics
Keywords: Pediatrics
Rabies post-exposure prophylaxis
Rabies PEP
Rabies immune globulin
Rabies IG
Adverse events
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Grifols Biologicals, LLC
First posted: 2022-05-19
Enrollment: 50
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration
timeFrame: Within 2 days of HRIG 300 IU/mL administration
Secondary outcomes:
measure: Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration
timeFrame: Within 10 days of HRIG 300 IU/mL administration
measure: Cumulative incidence of all local and systemic AEs within 30 days of HRIG 300 IU/mL administration
timeFrame: Within 30 days of HRIG 300 IU/mL administration
measure: Cumulative incidence of all local and systemic serious adverse events (SAEs) within 30 days of HRIG 300 IU/mL administration
timeFrame: Within 30 days of HRIG 300 IU/mL administration
measure: Type and severity of individual local and systemic AEs detected within 30 days of HRIG 300 IU/mL administration
timeFrame: Within 30 days of HRIG 300 IU/mL administration
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Sirimaturos, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.