Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Hepatitis B
In brief
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 more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.
Key facts
- Study ID
- NCT00426712
- Run by
- Dynavax Technologies Corporation
- People needed
- 42
- Starts
- 2006-01-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2019-03-20
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- West Coast Clinical Trials — Costa Mesa, California, United States
- Twin Cities Clinical Research — Brooklyn Center, Minnesota, United States
- Covance — Austin, Texas, United States
- University of Virginia Health System, Nephrology Clinical Research Center — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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