HyperRAB (rabies immune globulin [human]) / Grifols - LARVOL DELTA

Survey of Human Rabies Immune Globulin Safety in Children (clinicaltrials.gov) - P=N/A | N=35 | Terminated | Sponsor: The Methodist Hospital Research Institute | N=50 ➔ 35 | Recruiting ➔ Terminated; Slow enrollment

Enrollment change • Trial termination • Infectious Disease • Pediatrics

Survey of Human Rabies Immune Globulin Safety in Children (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: The Methodist Hospital Research Institute | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Infectious Disease • Pediatrics

Survey of Human Rabies Immune Globulin Safety in Children (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: The Methodist Hospital Research Institute | Initiation date: Aug 2022 ➔ Feb 2023

Trial initiation date • Infectious Disease • Pediatrics

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b | N=448 | Completed | Sponsor: Synermore Biologics Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Dec 2021 | Trial primary completion date: Jun 2022 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date

Survey of Human Rabies Immune Globulin Safety in Children (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: The Methodist Hospital Research Institute | Initiation date: May 2022 ➔ Aug 2022

Trial initiation date • Infectious Disease • Pediatrics

Survey of Human Rabies Immune Globulin Safety in Children (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: The Methodist Hospital Research Institute

New trial • Infectious Disease • Pediatrics

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b | N=448 | Active, not recruiting | Sponsor: Synermore Biologics Co., Ltd. | Trial completion date: May 2022 ➔ Aug 2022 | Trial primary completion date: Nov 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date

Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? (PubMed, Hum Vaccin Immunother) - "Currently there are 3 HRIG products on the US market, KEDRAB®, HyperRab® and Imogam® Rabies HT, but only KEDRAB® has published safety and efficacy data in a pediatric population. While it is common practice to prescribe medications for pediatric patients "off-label" there now exists one product with safety data in children. It is worth considering if this creates a higher medical liability for the prescriber and institution."

Journal • Pain • Pediatrics

Application of a caprylate/chromatography purification process for production of a high potency rabies immune globulin from pooled human plasma. (PubMed, J Immunol Methods) - "RIG-C is a more potent RIG formulation with less impurities yielding a safer and more convenient product with similar pharmacokinetic profile."

Journal • Allergy

Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial. (PubMed, Vaccine) - P1/2 | "SYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period."

Clinical • Combination therapy • Journal • P2 data • PK/PD data • Pain

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Active, not recruiting; Sponsor: Synermore Biologics Co., Ltd.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Feb 2021 ➔ Nov 2021

Trial completion date • Trial primary completion date

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Active, not recruiting; Sponsor: Synermore Biologics Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Nov 2021 ➔ Feb 2021

Clinical • Enrollment closed • Trial primary completion date

Improving Adherence to Rabies PEP Guideline Recommendations (clinicaltrials.gov) - P=N/A; N=70; Completed; Sponsor: Joshua Swan, PharmD, MPH, FCCM; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

[VIRTUAL] Cost-savings evaluation of rabies immune globulin and vaccine administration in a pediatric hospital emergency department based on CDC guidelines (ASHP 2020) - "Before May 2018, HRIG, HyperRab, came as 150 unit/mL in 2 mL vials, then was changed to 300 unit/mL in 1 mL vials, which both cost $804.53/vial... A substantial cost-savings opportunity within a pediatric ED was discovered through this study. Provider and family education are critical means to achieve this cost-savings opportunity. Providers should be educated on the appropriate scenarios to administer HRIG according to the CDC and families should be educated on the proper management of animals they encounter."

Clinical • HEOR • Pediatrics

[VIRTUAL] Retrospective review evaluating the cost-effectiveness of utilizing 300 IU/mL 1 mL human rabies immune globulin for post-exposure prophylaxis (PEP) in a community hospital (ASHP 2020) - "10 patients received the Hyperrab 300 IU/mL 5 mL vials solely or in combination with 1 mL vials to obtain the patient specific weight based dose... Dispensing human rabies immune globulin 1 mL vials instead of the larger vial size for PEP improves drug utilization by limiting waste and providing an overall annual cost savings to Piedmont Columbus Regional Midtown."

HEOR • Retrospective data • Review

Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects (clinicaltrials.gov) - P2/3; N=162; Completed; Sponsor: Bio Products Laboratory; Active, not recruiting ➔ Completed

Clinical • Head-to-Head • Trial completion

Improving Adherence to Rabies PEP Guideline Recommendations (clinicaltrials.gov) - P=N/A; N=70; Recruiting; Sponsor: Joshua Swan, PharmD, MPH, FCCM; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Improving Adherence to Rabies PEP Guideline Recommendations (clinicaltrials.gov) - P=N/A; N=70; Not yet recruiting; Sponsor: Joshua Swan, PharmD, MPH, FCCM

Clinical • New trial

Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects (clinicaltrials.gov) - P2/3; N=162; Active, not recruiting; Sponsor: Bio Products Laboratory; Trial completion date: Jul 2019 ➔ Oct 2019

Clinical • Head-to-Head • Trial completion date

Safety and efficacy results of simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine in healthy subjects: a comparative phase 2/3 trial. (PubMed, Hum Vaccin Immunother) - "We conducted a clinical trial to assess the safety and putative efficacy of an additional human rabies immune globulin (HRIG; KEDRAB) versus an older product (Comparator, HyperRAB S/D® [Grifols]) and determine whether HRIG interferes with development of endogenous antibodies versus Comparator, when each is given with an active rabies vaccine. One subject in the HRIG group did not meet the seroconversion criteria for anti-rabies antibody, and one subject in the Comparator group showed an anamnestic response, with much higher than expected anti-rabies antibody levels at both baseline and on day 14. Thus, HRIG allows for prophylactic anti-rabies antibody titers and is non-inferior to Comparator, when administered with rabies vaccine."

Clinical • Journal • P2/3 data

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Recruiting; Sponsor: Synermore Biologics Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2b; N=448; Not yet recruiting; Sponsor: Synermore Biologics Co., Ltd.

New P2b trial