Status:
COMPLETED
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
Hepatitis B
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with m...
Detailed Description
Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. About ...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent
- Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
- Body mass index of 31 or less
Exclusion
- Received previous vaccination with any HBV vaccine (1 or more doses)
- Any history of HBV infection
- Pregnant or breast-feeding, or planning a pregnancy during the study
- Has autoimmune disease
- Diagnosis of chronic kidney failure due to autoimmune disease
- Receiving hemodialysis treatment at the time of enrollment
- Received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
- Ever received an injection with DNA plasmids or oligonucleotides
- Received erythropoietin within 7 days prior to the first study injection
- Received vaccination with any vaccines during the 4 weeks prior to study entry
- Received any other investigational medicinal agent during the 4 weeks prior to study entry
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00426712
Start Date
January 1 2006
End Date
March 1 2008
Last Update
March 20 2019
Active Locations (4)
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1
West Coast Clinical Trials
Costa Mesa, California, United States, 92626
2
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
3
Covance
Austin, Texas, United States, 78727
4
University of Virginia Health System, Nephrology Clinical Research Center
Charlottesville, Virginia, United States, 22908