Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426712
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2007-01-23
Brief Title:
Safety of HEPLISAV Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
Sponsor:
Dynavax Technologies Corporation
Organization:
Dynavax Technologies Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 more advanced stage 3 GFR 45 mLmin or stage 4 chronic kidney disease and are expected to eventually go on hemodialysis
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 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 mLmin 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 localsystemic reactogenicity
Comparison Patients will receive treatment with one of three escalating dose levels of HEPLISAV or the comparator vaccine Engerix-B
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 mLmin 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 localsystemic reactogenicity
Comparison Patients will receive treatment with one of three escalating dose levels of HEPLISAV or the comparator vaccine Engerix-B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None