A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT00656097
First received: April 4, 2008
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.


Condition Intervention Phase
Rabies
Biological: CL184
Biological: HRIG
Biological: Placebo matching CL184
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rabies virus neutralizing activity [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
CL184 combined with rabies vaccination
Biological: CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Active Comparator: B
HRIG combined with rabies vaccination
Biological: HRIG
HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Placebo Comparator: C
Placebo combined with rabies vaccination
Biological: Placebo matching CL184
Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects free of obvious health-problems or with stable condition
  • Male or female subjects aged ≥19 to ≤65 years
  • BMI between ≥18 and ≤30 kg/m2

Exclusion Criteria:

  • Prior history of active or passive rabies immunization
  • Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
  • History and/or family history of clinically significant immunodeficiency or auto-immune disease
  • Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656097

Locations
United States, Nebraska
MDS Pharma Services , USA
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: C. James Kissling, MD MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT00656097     History of Changes
Other Study ID Numbers: RAB-M-A003
Study First Received: April 4, 2008
Last Updated: September 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Crucell Holland BV:
Rabies post-exposure prophylaxis

Additional relevant MeSH terms:
Rabies
Mononegavirales Infections
Rhabdoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014