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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

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Disease Information

Descriptive Information
Brief Title † 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
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
Brief Summary 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary Outcome Measure † Safety and tolerability
Secondary Outcome Measure † Rabies virus neutralizing activity
Condition † Rabies
Intervention † BiologicalCL184
Study Arms / Comparison Groups A CL184 combined with rabies vaccination B HRIG combined with rabies vaccination C Placebo combined with rabies vaccination
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 140
Start Date † March 2008
Completion Date July 2008
Primary Completion Date July 2008
Eligibility 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
Gender Both
Ages 19 Years - 65 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00656097
Organization ID RAB-M-A003
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Crucell Holland BV
Collaborators ††
Investigators † Principal Investigator: C. James Kissling, MD, MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
Information Provided By
Verification Date September 2011
First Received Date † April 4, 2008
Last Updated Date September 15, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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