NCT03264157

Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects

A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.

Detailed description

Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment (BPL HRIG + vaccine or Comparator HRIG + vaccine) on Day 0. Further assessments will be conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140. Vaccine will be administered on Day 0, 3, 7, 14 and 28.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HRIG	A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.
DRUG	HyperRAB	A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
BIOLOGICAL	RabAvert	A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-03-02
• Completion: 2018-07-13
• First posted: 2017-08-29
• Last updated: 2020-02-25
• Results posted: 2020-02-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study