Survey of Human Rabies Immune Globulin Safety in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children

Conditions
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Rabies, Rabies Human, Rabies Virus Infection, Pediatrics

Intervention / Treatment
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* Biological: Human rabies immune globulin 300 IU/mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit Aged ≤17 years Exclusion Criteria 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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of all local and systemic AEs within 10 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 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 | Proportion of patients with 1 or more AEs deemed as possibly/definitely related to 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 | Proportion of patients with 1 or more SAE deemed as possibly/definitely related to HRIG 300 IU/mL administration. An AE is considered serious if any of the following outcomes occur: Death Life-threatening AE (life-threatening in the definition of serious refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) In-patient hospitalization or prolongation of existing hospitalization A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions An important medical event (refers to events which may not be immediately life-threatening, or result in death, or hospitalization, but from medical and scientific judgment, may jeopardize the participant or/and may require medical or surgical intervention to prevent one of the other outcomes listed above). | 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 | Proportions of AEs that are local vs systemic and proportions of AEs that are mild, moderate, or severe among AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration | Within 30 days of HRIG 300 IU/mL administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Rabies post-exposure prophylaxis, Rabies PEP, Rabies immune globulin, Rabies IG, Adverse events