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Phase II/III Study of the Safety and Effectiveness of HRIG With Co-administration of Active Rabies Vaccine in Healthy Subjects (KAMRAB-003)

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ClinicalTrials.gov Identifier: NCT02040090
Recruitment Status : Unknown
Verified July 2014 by Kamada, Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Rabies Drug: Active rabies vaccine (US-FDA approved) Biological: KamRAB Biological: FDA approved commercially available HRIG product Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
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
Study Start Date : April 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: KamRAB
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Drug: 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.

Biological: KamRAB
Active Comparator: FDA approved commercially available HRIG product
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Drug: 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.

Biological: FDA approved commercially available HRIG product



Primary Outcome Measures :
  1. Anti-rabies IgG concentration [ Time Frame: 6 months from dosing ]

Secondary Outcome Measures :
  1. PK Parameters [ Time Frame: 6 months from dosing ]
    Cmax

  2. Safety and tolerability [ Time Frame: 6 months from dosing ]
    Adverse Events

  3. PK parameters [ Time Frame: 6 months from dosing ]
    tmax

  4. PK parameters [ Time Frame: 6 months from dosing ]
    AUC

  5. PK parameters [ Time Frame: 6 months from dosing ]
    t1/2 of anti-rabies IgG antibody concentrations

  6. Safety and tolerability [ Time Frame: 6 months from dosing ]
    Serious adverse events

  7. Safety and tolerability [ Time Frame: 6 months from dosing ]
    Physical examination

  8. Safety and tolerability [ Time Frame: 6 months from dosing ]
    Vital signs



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040090


Locations
United States, Minnesota
Prism Research Inc
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Kamada, Ltd.
Investigators
Principal Investigator: Mark Matson, M.D. Prism Research Inc

Responsible Party: Kamada, Ltd.
ClinicalTrials.gov Identifier: NCT02040090     History of Changes
Other Study ID Numbers: KAMRAB-003
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs