Back to resultsA 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
Primary Purpose
Rabies
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CL184
HRIG
Placebo matching CL184
Sponsored by
About this trial
This is an interventional treatment trial for Rabies focused on measuring Rabies post-exposure prophylaxis
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
Sites / Locations
- MDS Pharma Services , USA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
A
B
C
Arm Description
CL184 combined with rabies vaccination
HRIG combined with rabies vaccination
Placebo combined with rabies vaccination
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
Rabies virus neutralizing activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656097
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies post-exposure prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
CL184 combined with rabies vaccination
Arm Title
B
Arm Type
Active Comparator
Arm Description
HRIG combined with rabies vaccination
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo combined with rabies vaccination
Intervention Type
Biological
Intervention Name(s)
CL184
Intervention Description
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Intervention Type
Biological
Intervention Name(s)
HRIG
Intervention Description
HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Intervention Type
Biological
Intervention Name(s)
Placebo matching CL184
Intervention Description
Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Rabies virus neutralizing activity
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. James Kissling, MD
Organizational Affiliation
MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services , USA
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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