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Sponsored by: |
Dynavax Technologies Corporation |
Information provided by: | Dynavax Technologies Corporation |
ClinicalTrials.gov Identifier: | NCT00498212 |
The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. The study will determine which dose does this best.
Condition | Intervention | Phase |
Hepatitis B |
Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen |
Phase II |
MedlinePlus related topics: | Hepatitis Hepatitis B Kidney Failure |
ChemIDplus related topics: | Hepatitis B Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Single-Blind, Randomized Study of Safety and Immunogenicity Following Vaccination With Single or Double Doses of HEPLISAV™ in Adults With End-Stage Renal Disease |
Enrollment: | 41 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Single dose (3000 µg 1018 ISS + 20 µg rHBsAg)
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Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen
IM (in the muscle) injection at Day 0, Week 4 and Week 24
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2: Experimental
Double dose (6000 µg 1018 ISS + 40 µg rHBsAg)
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Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen
IM (in the muscle) injection at Day 0, Week 4 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. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.
This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate [GFR] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens:
Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity.
Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies [anti-HBsAg] ≥ 10 mIU/mL) at Weeks 4, 12, 24, 28 and 50.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Newfoundland and Labrador | |||||
White Hills Medical Clinic | |||||
St Johns, Newfoundland and Labrador, Canada, A1A 3R5 | |||||
Canada, Nova Scotia | |||||
QEII Health Sciences Centre | |||||
Halifax, Nova Scotia, Canada, B3H 1E7 | |||||
Canada, Quebec | |||||
SMBD - Jewish General Hospital | |||||
Montreal, Quebec, Canada, H3T 1E2 |
Dynavax Technologies Corporation |
Study Director: | Eduardo Martins, MD, D Phil | 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-11 |
First Received: | July 5, 2007 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00498212 |
Health Authority: | Canada: Health Canada |
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