Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects

NCT02040090 | Completed Phase 2 Results

• 1 other identifier: KAMRAB-003
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Conditions

Rabies

Outcome Measures

Primary Outcomes (1)

• The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL

  Day 14

Study Arms (2)

KamRAB

EXPERIMENTAL

KamRAB 20 IU/kg body weight via IM injection, once on Day 0

Drug: Active rabies vaccine (US-FDA approved)

FDA approved HRIG product

ACTIVE COMPARATOR

Comparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB.

Drug: Active rabies vaccine (US-FDA approved)

Interventions

Active rabies vaccine (US-FDA approved) DRUG

A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.

Also known as: RabAvert®

FDA approved HRIG product; KamRAB

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.
• Healthy male or female subjects of 18 - 75 years of age inclusive who have not previously been immunized against rabies.
• Ability to comply with completion of a home diary.
• No previous exposure to Rabies epidemic, Rabies vaccine and/or Rabies Immune globulin.
• No significant abnormalities in serum hematology, serum chemistry and serum immunogenic markers (C3, C4 and C50) according to the Principal Investigator's judgment.
• No significant abnormalities in urinalysis according to the Principal Investigator's judgment.
• No significant abnormalities in ECG per investigator judgment.
• Non-pregnant, non-lactating female subjects, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator, or who are more than 5 years post-menopausal or surgically sterilized.
• Male subjects must be using at least one effective contraceptive method before study start and throughout the entire duration of the study.

You may not qualify if:

• History or laboratory evidence of immunoglobulin A deficiency.
• A history of previous administration of rabies vaccine or HRIG.
• History of live virus vaccine administration, e.g., measles vaccine, within the last 3 months.
• 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 hypersensitivity reaction to any of the components in an equivalent active Rabies vaccine.
• History of allergy to blood or blood products.
• History of bleeding disorders.
• Fever at the time of the start of the infusion. (Oral temperature \>38ºC.)
• Clinically significant intercurrent 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.
• Evidence of active systemic infection that required treatment with antibiotics within 2 weeks of the time of drug administration.
• Evidence of uncontrolled hypertension (systolic blood pressure of \>150 mm Hg, and/or diastolic blood pressure of \>100 mm Hg).
• Heart rate \>120/min.
• Weight \> 93.75 kg
• Pregnancy and/or lactation.
• Woman of child-bearing potential not taking adequate contraception deemed reliable by the investigator.

Sponsors & Collaborators

• Kamada, Ltd.: lead

Study Sites (1)

Prism Research Inc

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Eran Schenker, VP Medical Director
• Organization: Kamada

Erans@kamada.com

+972-8-9406472

Study Officials

• Mark Matson, M.D.

  Prism Research Inc

  PRINCIPAL INVESTIGATOR

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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: January 20, 2014
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2016-04

Locations

US (1)