NCT03264157 is a Phase 2, PHASE3 clinical trial of HRIG in Healthy, sponsored by Bio Products Laboratory.

Who is sponsoring NCT03264157?

NCT03264157 is sponsored by Bio Products Laboratory.

What drugs are being tested in NCT03264157?

Interventions in NCT03264157: HRIG, HyperRAB, RabAvert.

Is NCT03264157 still recruiting?

NCT03264157 is currently completed. Last updated 25 February 2020.

Are results published for NCT03264157?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-02-25 · How we verify

NCT03264157

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Results posted Last updated 25 February 2020

What this trial tests

Phase 2, PHASE3 trial testing HRIG in Healthy in 162 participants. Completed in 13 July 2018.

Timeline

8 December 2017

Primary endpoint
2 March 2018

13 July 2018

Quick facts

Lead sponsor	Bio Products Laboratory
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	162
Start date	8 December 2017
Primary completion	2 March 2018
Estimated completion	13 July 2018
Sites	2 locations across United States

Drugs / interventions tested

HRIG — full drug profile →
HyperRAB — full drug profile →
RabAvert — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Bio Products Laboratory — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL Primary · Day 14

Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%.

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	72

Analysis of AUC0-7d Secondary · Day 0 to Day 7

The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.

Group	Value	95% CI
BPL HRIG + RabAvert	1.10	1.02 – 1.20
Comparator HyperRab + RabAvert	1.32	1.21 – 1.44

RVNA Geometric Mean Titers at Days 3, 5, 7 and 14 Secondary · Days 3, 5, 7 and 14

Comparison of the geometric mean titers (GMTs) for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine. The median peak RVNA titer occurred at Day 14, which is reflected in the analysis. The RVNA titer to peak geometric mean is analyzed using a repeated measures analysis. The inferential test compares RVNA values between BPL HRIG and HyperRab in a single analysis across all visits at or below the visit at which peak titer is observed. The geometric mean values presented represent a mean across all visits from baseline through and including

Through Day 14

Group	Value	95% CI
BPL HRIG + RabAvert	0.37	0.35 – 0.39
Comparator HyperRab + RabAvert	0.38	0.36 – 0.40

Day 3

Group	Value	95% CI
BPL HRIG + RabAvert	0.18	0.16 – 0.20
Comparator HyperRab + RabAvert	0.21	0.19 – 0.24

Day 5

Group	Value	95% CI
BPL HRIG + RabAvert	0.19	0.18 – 0.21
Comparator HyperRab + RabAvert	0.24	0.21 – 0.26

Day 7

Group	Value	95% CI
BPL HRIG + RabAvert	0.23	0.21 – 0.26
Comparator HyperRab + RabAvert	0.26	0.23 – 0.29

Day 14

Group	Value	95% CI
BPL HRIG + RabAvert	12.30	10.15 – 14.90
Comparator HyperRab + RabAvert	8.38	6.54 – 10.74

Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit Secondary · Days 3, 5, 7, 14, 28, 49, and 140

The proportion of subjects reaching antirabies antibody titer of ≥ 0.5 IU/mL after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.

Day 0

Group	Value	95% CI
BPL HRIG + RabAvert	0
Comparator HyperRab + RabAvert	0

Day 3

Group	Value	95% CI
BPL HRIG + RabAvert	0
Comparator HyperRab + RabAvert	1

Day 5

Group	Value	95% CI
BPL HRIG + RabAvert	0
Comparator HyperRab + RabAvert	1

Day 7

Group	Value	95% CI
BPL HRIG + RabAvert	3
Comparator HyperRab + RabAvert	2

Day 14

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	72

Day 28

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	73

Day 49

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	72

Day 140

Group	Value	95% CI
BPL HRIG + RabAvert	60
Comparator HyperRab + RabAvert	65

Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit Secondary · Days 3, 5, 7, 14, 28, 49, and 140

The proportion of subjects reaching antirabies antibody titer of ≥ LLOQ of the assay at each visit after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.

Day 0

Group	Value	95% CI
BPL HRIG + RabAvert	0
Comparator HyperRab + RabAvert	0

Day 3

Group	Value	95% CI
BPL HRIG + RabAvert	70
Comparator HyperRab + RabAvert	73

Day 5

Group	Value	95% CI
BPL HRIG + RabAvert	71
Comparator HyperRab + RabAvert	74

Day 7

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	74

Day 14

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	74

Day 28

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	74

Day 49

Group	Value	95% CI
BPL HRIG + RabAvert	73
Comparator HyperRab + RabAvert	72

Day 140

Group	Value	95% CI
BPL HRIG + RabAvert	62
Comparator HyperRab + RabAvert	71

RVNA Geometric Mean Titers at Days 14, 28, 49 and 140 Secondary · Days 14, 28, 49 and 140

Comparison of the GMTs for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine to assess the inhibitory effects of BPL HRIG on active immunization relative to that of the comparator HRIG.

Day 14

Group	Value	95% CI
BPL HRIG + RabAvert	12.30	10.15 – 14.90
Comparator HyperRab + RabAvert	8.38	6.54 – 10.74

Day 28

Group	Value	95% CI
BPL HRIG + RabAvert	10.18	8.39 – 12.34
Comparator HyperRab + RabAvert	7.78	6.26 – 9.66

Day 49

Group	Value	95% CI
BPL HRIG + RabAvert	10.91	8.94 – 13.32
Comparator HyperRab + RabAvert	7.78	6.34 – 9.56

Day 140

Group	Value	95% CI
BPL HRIG + RabAvert	2.72	2.21 – 3.34
Comparator HyperRab + RabAvert	2.02	1.62 – 2.53

Adverse events — posted to ClinicalTrials.gov

Time frame: 20 weeks treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BPL HRIG + RabAvert

Serious: 0/81 (0%)

Deaths: 0/81

Comparator HyperRab + RabAvert

Serious: 0/81 (0%)

Deaths: 0/81

Other adverse events (3 terms — click to expand)

Reaction	System	BPL HRIG + RabAvert	Comparator HyperRab + RabA…
Headache	Nervous system disorders	—	—
Vaccination site pain	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03264157 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of HRIG

Trials testing the same drug.

NCT07342257 — SYN023 With Rabies Vaccine in Healthy Pediatric Subjects · Phase 1 · completed

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Other Bio Products Laboratory trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03264157 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bio Products Laboratory
Last refreshed: 25 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03264157.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03264157

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of HRIG

Other recruiting trials for Healthy

Other Bio Products Laboratory trials

Verify against primary sources