Survey of Human Rabies Immune Globulin Safety in Children

Learn more about:
Related Clinical Trial
Survey of Human Rabies Immune Globulin Safety in Children Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project Immunity Persistence After Abridged Intradermal Rabies PEP A Phase III Clinical Study to Evaluate SYN023’s Efficacy and Safety Immunogenicity and Safety of Verorab® in a “One-week” Intradermal Post-exposure Prophylaxis Regimen Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule) Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects. Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG Immunogenicity and Safety of Verorab™ in Indian Population A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination Phase II/III Study of the Safety and Effectiveness of HRIG With Co-administration of Active Rabies Vaccine in Healthy Subjects Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. The Safety Research of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac’s Candidate Rabies mRNA Vaccine in Healthy Adults A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules RNActive® Rabies Vaccine (CV7201) in Healthy Adults Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients Rabies Immunization Concomitant With JEV in Children A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human) Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly A Phase Ib Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG Rabies Immune Plasma Booster Study Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose Immune Response After Booster Vaccination in HIV – Infected Patients Who Received Rabies Primary Vaccination Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen Simplifying the Rabies Pre-exposure Vaccination Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response Improving Adherence to Rabies PEP Guideline Recommendations Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant Study of the Purified Vero Rabies Vaccine – Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use Immunological Tolerance After Frequent Rabies Booster Vaccinations Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

Brief Title

Survey of Human Rabies Immune Globulin Safety in Children

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Rabies

Intervention

Human rabies immune globulin 300 IU/mL


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

50

Start Date

May 2022

Completion Date

July 2024

Primary Completion Date

June 2024

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
      

Gender

All

Ages

N/A - 17 Years


Contacts

Michael Sirimaturos, PharmD, 346-356-1692, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05382650

Organization ID

PRO00028137


Responsible Party

Principal Investigator

Study Sponsor

The Methodist Hospital Research Institute

Collaborators

 Grifols Biologicals, LLC

Study Sponsor

Michael Sirimaturos, PharmD, Principal Investigator, The Methodist Hospital Research Institute


Verification Date

May 2022