Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
Information source: Crucell Holland BV
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rabies
Intervention: Rabies virus-specific monoclonal antibodies (Biological); human polyclonal rabies immune globulin (HRIG) (Biological); Placebo (Biological); Human diploid cell vaccine (HDCV) (Biological); Purified verocell rabies vaccine (PVRV) (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Crucell Holland BV Official(s) and/or principal investigator(s): G Nagashayana, MD, Principal Investigator, Affiliation: Lotus Labs Pvt. Ltd, Bangalore, India
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
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).
Clinical Details
Official title: 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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Number of participants with adverse events as a measure of safety
Secondary outcome: Rabies virus neutralizing activity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lotus House, Vasanth Nagar, Bangalore, Karnataka 560 052, India
Additional Information
Starting date: December 2011
Last updated: April 3, 2013
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