Hepatitis B Clinical Trial
Official title:
A Phase 1, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to Recombinant Hepatitis B Virus Surface Antigen (rHBsAg) Co-administered With Dynavax Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide (1018 ISS)
NCT number | NCT00426712 |
Other study ID # | DV2-HBV-09 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2006 |
Est. completion date | March 2008 |
Verified date | March 2019 |
Source | Dynavax Technologies Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Covance | Austin | Texas |
United States | Twin Cities Clinical Research | Brooklyn Center | Minnesota |
United States | University of Virginia Health System, Nephrology Clinical Research Center | Charlottesville | Virginia |
United States | West Coast Clinical Trials | Costa Mesa | California |
Lead Sponsor | Collaborator |
---|---|
Dynavax Technologies Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of adverse events and local and systemic reaction rates | 28 weeks | ||
Secondary | Portion of subjects who have a seroprotective immune response (anti-HBsAg antibody = 10 mIU/mL) | 28 days |
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