RabiesNCT05382650
Survey of Human Rabies Immune Globulin Safety in Children
An observational study of Rabies and Rabies Human, run by The Methodist Hospital Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Rabies, Rabies Human, Rabies Virus Infection
- What is being tested?
- Human rabies immune globulin 300 IU/mL
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2023to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
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
Who may be able to join
- Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
- Aged ≤17 years
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children
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.
Read the 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
- Being tested
- Human rabies immune globulin 300 IU/mL
- Keywords
- Pediatrics, Rabies post-exposure prophylaxis, Rabies PEP, Rabies immune globulin, Rabies IG, Adverse events
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human rabies immune globulin 300 IU/mLBiological
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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
Measured: 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
Measured: 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).
Measured: 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
Measured: Within 30 days of HRIG 300 IU/mL administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start22 Feb 2023
- Primary completion17 Sep 2025
- Study completion15 Oct 2025
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Principal investigator, Michael Sirimaturos, The Methodist Hospital Research Institute
- Investigators
- Michael Sirimaturos, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382650
- Sponsor's protocol ID
- PRO00028137
- Status last verified
- Nov 2025
- First submitted
- 28 Apr 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18496505Hwang 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.
PubMed 31210569Hanna 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.
PubMed 29983597
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children
- ClinicalTrials.gov ID
- NCT05382650
- Acronym / sponsor ID
- PRO00028137
- Conditions
- Rabies, Rabies Human, Rabies Virus Infection, Pediatrics
- Keywords
- Pediatrics, Rabies post-exposure prophylaxis, Rabies PEP, Rabies immune globulin, Rabies IG, Adverse events
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
- Aged ≤17 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human rabies immune globulin 300 IU/mLAll 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. | Biological | – |
Primary outcome
Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration
Time frame: 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
4 secondary outcomes
Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within 30 days of HRIG 300 IU/mL administration
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Background: PubMed 18496505Manning 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.
- Background: PubMed 31210569Hwang 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.
- Background: PubMed 29983597Hanna 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.
- Kamada Ltd., Kedrion Biopharma. U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG). Accessed April 11, 2022Link provided by the sponsor.
- 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, 2022Link provided by the sponsor.
- World Health Organization. Rabies. Accessed April 11, 2022Link provided by the sponsor.
- HyperRab® \[rabies immune globulin (human)\] \[package insert\]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2021. Accessed April 11, 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sirimaturos, PharmD principal investigator
The Methodist Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies and Rabies Human, run by The Methodist Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration (time frame: Within 2 days of HRIG 300 IU/mL administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382650, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.