A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.
Inclusion Criteria:
Exclusion Criteria: