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Sponsored by: |
Dynavax Technologies Corporation |
Information provided by: | Dynavax Technologies Corporation |
ClinicalTrials.gov Identifier: | NCT00426712 |
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.
Condition | Intervention | Phase |
Hepatitis B |
Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen Biological: Hepatitis B Vaccine (Recombinant) |
Phase I |
MedlinePlus related topics: | Hepatitis Hepatitis B Kidney Failure |
ChemIDplus related topics: | Hepatitis B Vaccines Sodium chloride |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study |
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) |
Enrollment: | 42 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Low dose
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Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
IM (in the muscle) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
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2: Experimental
Middle dose
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Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
IM (in the muscle) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
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3: Experimental
High dose
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Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
IM (in the muscle) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8
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4: Active Comparator |
Biological: Hepatitis B Vaccine (Recombinant)
IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24
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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 25% of people who do not initially clear the infection will later develop chronic active hepatitis. Hemodialysis and pre-dialysis patients with kidney failure have multiple immune defects that make them more likely to develop a chronic infection. In addition, hemodialysis increases the risk of exposure to HBV. Existing HBV vaccines are effective in preventing infection in healthy adults. However, poor responses occur in people who are over 40 years of age and have end-stage kidney failure.
This study will evaluate the safety, tolerability and immune response of three escalating dose levels of HEPLISAV™, compared with a commercially available HBV vaccine, Engerix-B®, 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. About 72 patients will be included in the study. Once patients have been consented, screened, and randomized to treatment, they will receive four injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Patients will receive treatment with one of three escalating dose levels of HEPLISAV™ or the comparator vaccine, Engerix-B®.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
West Coast Clinical Trials | |||||
Costa Mesa, California, United States, 92626 | |||||
United States, Minnesota | |||||
Twin Cities Clinical Research | |||||
Brooklyn Center, Minnesota, United States, 55430 | |||||
United States, Texas | |||||
Covance | |||||
Austin, Texas, United States, 78727 | |||||
United States, Virginia | |||||
University of Virginia Health System, Nephrology Clinical Research Center | |||||
Charlottesville, Virginia, United States, 22908 |
Dynavax Technologies Corporation |
Study Director: | Eduardo Martins, MD, DPhil | Dynavax Technologies Corporation |
Dynavax Webpage 
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Responsible Party: | Dynavax Technologies Corporation ( Eduardo Martins, MD, DPhil / Vice President, Clinical Development ) |
Study ID Numbers: | DV2-HBV-09 |
First Received: | January 23, 2007 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00426712 |
Health Authority: | United States: Food and Drug Administration |
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