Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511095
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2007-07-25
Brief Title:
Open-Label Study of the Safety and Immunogenicity of HEPLISAV Hepatitis B Virus Vaccine
Sponsor:
Dynavax Technologies Corporation
Organization:
Dynavax Technologies Corporation
Study Overview
Official Title:
An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV
Status:
COMPLETED
Status Verified Date:
2019-04
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 further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus HBV vaccine HEPLISAV in subjects 11-55 years old The primary hypothesis is that HEPLISAV is well tolerated
Detailed Description:
This study will evaluate the safety and efficacy of two injections of HEPLISAV in subjects 11 to 55 years old About 200 subjects will be included in the study Once subjects have been consented and screened they will receive a total of two injections over a 28-day period with follow-up visits at 8 12 and 28 weeks Safety and tolerability will be evaluated by occurrence of adverse events periodic laboratory tests vital signs and localsystemic reactogenicity
Comparison This study does not include a control treatment all subjects will receive treatment with HEPLISAV
Comparison This study does not include a control treatment all subjects will receive treatment with HEPLISAV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None