Overview

This trial is active, not recruiting.

Condition rabies
Treatments active rabies vaccine (us-fda approved), kamrab, fda approved commercially available hrig product
Phase phase 2/phase 3
Sponsor Kamada, Ltd.
Start date April 2013
End date August 2014
Trial size 118 participants
Trial identifier NCT02040090, KAMRAB-003

Summary

The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose health services research
Arm
(Experimental)
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
active rabies vaccine (us-fda approved) Active Rabies Vaccine (US-FDA approved)
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.
kamrab
(Active Comparator)
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
active rabies vaccine (us-fda approved) Active Rabies Vaccine (US-FDA approved)
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.
fda approved commercially available hrig product

Primary Outcomes

Measure
Anti-rabies IgG concentration
time frame: 6 months from dosing

Secondary Outcomes

Measure
PK Parameters
time frame: 6 months from dosing
Safety and tolerability
time frame: 6 months from dosing
PK parameters
time frame: 6 months from dosing
PK parameters
time frame: 6 months from dosing
PK parameters
time frame: 6 months from dosing
Safety and tolerability
time frame: 6 months from dosing
Safety and tolerability
time frame: 6 months from dosing
Safety and tolerability
time frame: 6 months from dosing

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - History or laboratory evidence of IgA 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 anaphylactic or anaphylactoid hypersensitivity reactions to chicken egg; history of mild allergic reactions to chicken egg, e.g., skin rash only, is not an exclusion criterion - 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. - All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer or situ cervical carcinoma must be in remission for a minimum of 5 years., For non-melanoma skin cancers and carcimona in-situ of the cervix may be enrolled if treated and cured at the time of screening. - Previous organ transplant recipient. - Evidence of ongoing infection with HAV, HCV, HBV, or HIV 1/2). - Presence of psychiatric disorder, other mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol. - Previous enrolment in this study. - Participation in another clinical trial within 30 days prior to baseline visit. - Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs in the past 10 years. - History of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products. - Known hypersensitivity to any of the ingredients or excipients of the study drugs. - Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.

Additional Information

Official title A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Effectiveness of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) With Co-administration of Active Rabies Vaccine in Healthy Subjects
Principal investigator Mark Matson, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Kamada, Ltd..