Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
April 3, 2013 updated by: Crucell Holland BV
A Randomized, Single-blind, Active-controlled, Mono-center Phase II Study to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Purified Vero Cell Rabies Vaccine vs. Human Rabies Immune Globulin or Placebo in Combination With Purified Vero Cell Rabies Vaccine vs. CL184 or Placebo in Combination With Human Diploid Cell Rabies Vaccine in Healthy Adult Subjects
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 vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study
Study objectives:
Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.
Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).
Study Overview
Status
Completed
Conditions
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 be applied as simulated PEP regimen to healthy subjects (i.e. in a pre-exposure setting) in this study.
A comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine.
RVNA provided by CL184 or HRIG, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary.
In addition pharmacokinetic data will be collected.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karnataka
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Bangalore, Karnataka, India, 560 052
- Lotus House, Vasanth Nagar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CL184+PVRV
CL184 with rabies vaccine (PVRV)
|
CL184 20 IU/kg intramuscularly on Day 0.
Other Names:
Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
Other Names:
|
|
ACTIVE_COMPARATOR: HRIG+PVRV
HRIG with rabies vaccine
|
Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
Other Names:
HRIG 20 IU/kg intramuscularly on Day 0.
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo+PVRV
Placebo with rabies vaccine (PVRV)
|
Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
Other Names:
Placebo intramuscularly on Day 0.
|
|
EXPERIMENTAL: CL184+HDCV
CL184 with rabies vaccine (HDCV)
|
CL184 20 IU/kg intramuscularly on Day 0.
Other Names:
Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo+HDCV
Placebo with rabies vaccine (HDCV)
|
Placebo intramuscularly on Day 0.
Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with adverse events as a measure of safety
Time Frame: 90 days
|
Assessed by recording unsolicited adverse events, solicited local and systemic adverse events, and pain at the injection site (assessed on a Visual Analog Scale from Day 0 to Day 3); routine safety laboratory assessed on Days -1, 1, 3, 7, 42, and 90; ECG and vital signs assessed on Days -1, 7, and 90.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rabies virus neutralizing activity
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: G Nagashayana, MD, Lotus Labs Pvt. Ltd, Bangalore, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
October 13, 2010
First Submitted That Met QC Criteria
October 25, 2010
First Posted (ESTIMATE)
October 26, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 10, 2013
Last Update Submitted That Met QC Criteria
April 3, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAB-M-A008
- U1111-1120-1647 (OTHER: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.