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

NCT03264157 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2020-02-25

Study results available
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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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Principal Investigators

  • Elizabeth Holmes, MD · Bio Products Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-03-02
Completion
2018-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03264157 on ClinicalTrials.gov