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

NCT03264157 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RIG01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL

  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%.

  Day 14

Secondary Outcomes (5)

• Analysis of AUC0-7d

  Day 0 to Day 7

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

  Days 3, 5, 7 and 14

• Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit

  Days 3, 5, 7, 14, 28, 49, and 140

• Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit

  Days 3, 5, 7, 14, 28, 49, and 140

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

  Days 14, 28, 49 and 140

Study Arms (2)

BPL HRIG + RabAvert

EXPERIMENTAL

20 IU/kg dose HRIG + active rabies vaccine

Drug: HRIG; Biological: RabAvert

Comparator HyperRab + RabAvert

ACTIVE COMPARATOR

20 IU/kg dose HRIG + active rabies vaccine

Drug: HyperRAB; Biological: RabAvert

Interventions

HRIG DRUG

A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.

BPL HRIG + RabAvert

HyperRAB DRUG

A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.

Also known as: HRIG

Comparator HyperRab + RabAvert

RabAvert BIOLOGICAL

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.

Also known as: active rabies vaccine

BPL HRIG + RabAvert; Comparator HyperRab + RabAvert

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to sign an informed consent form.
• Healthy male or female subjects aged 18 - 75 years inclusive.
• No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.
• No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.
• No significant abnormalities in ECG according to the Investigator's judgment.
• Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) who are (or become) sexually active must agree to practice contraception by using a highly effective (\>98%) method for the duration of the study.
• Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) must have a negative result on a serum at screening visit and a urine HCG-based pregnancy test at Day 0.

You may not qualify if:

• Female subjects who are pregnant and/or lactating.
• History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.
• Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day 0.
• History of hypersensitivity reaction to any of the following components of active rabies vaccine (US-FDA approved) e.g.: neomycin, bovine gelatin, trace amounts of chicken protein, chlortetracycline, and amphotericin B and in accordance with the product insert of the vaccine.
• History of life-threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
• History of life-threatening allergy to blood or blood products.
• Fever at the time of the start of the injection (oral temperature \>38ºC.) or acute illness at the time of the start of the injection. Subjects with fever on Day 0 may have entry to the study re-scheduled.
• History of or ongoing bleeding disorder.
• Previous organ transplant recipient.
• Ongoing immunosuppressive illness.
• Clinically significant illnesses including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study.
• All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer, in- situ cervical carcinoma must be in remission for a minimum of 5 years prior to Day 0. For non-melanoma skin cancers and carcinoma in-situ of the cervix may be enrolled if treated and cured at the time of screening.
• Evidence of active systemic infection that requires treatment with antibiotics within 2 weeks prior to Day 0.
• Currently receiving or have received within the past 6 months (prior to Day 0):
• immunosuppressive drugs

Sponsors & Collaborators

• Bio Products Laboratory: lead

Study Sites (2)

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Bio Products Laboratory

MedInfo@bpl-us.com

1-844-4BPLUSA

Study Officials

• Elizabeth Holmes, MD

  Bio Products Laboratory

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccine

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: December 8, 2017
• Primary Completion: March 2, 2018
• Study Completion: July 13, 2018
• Last Updated: February 25, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-01

Locations

US (2)