Status:
COMPLETED
Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
Lead Sponsor:
Crucell Holland BV
Conditions:
Rabies
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Study design: Single-blind (subject and observer-blinded), active-controlled, randomized \[6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV v...
Detailed Description
This study was designed to explore and obtain further safety and RVNA data on CL184 in comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP) regimen. This regimen will ...
Eligibility Criteria
Inclusion
- Male or female subject aged ≥18 to ≤55 years
- Subjects free of obvious health-problems or with stable conditions or medications
- Body mass index between ≥18 to ≤30 kg/m2
- Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
- Male subjects must agree that they will not donate sperm from the first check-in until Day 90
- Subject signed written informed consent
Exclusion
- Prior history of active or passive rabies immunization
- Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Planned immunization with live vaccines during the coming 3 months after first dosing
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01228383
Start Date
December 1 2011
End Date
December 1 2012
Last Update
April 10 2013
Active Locations (1)
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1
Lotus House, Vasanth Nagar
Bangalore, Karnataka, India, 560 052