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NCT00656097 Clinical 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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00656097
Other study ID # RAB-M-A003
Secondary ID
Status Completed
Phase Phase 2
First received April 4, 2008
Last updated September 15, 2011
Start date March 2008
Est. completion date July 2008

Study information
Verified date September 2011
Source Crucell Holland BV
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• CL184
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
• HRIG
HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
• Placebo matching CL184
Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28

Locations
Country Name City State
United States MDS Pharma Services , USA Lincoln Nebraska

Sponsors (1)
Lead Sponsor Collaborator
Crucell Holland BV

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability 42 days Yes
Secondary Rabies virus neutralizing activity 42 days No
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