NCT00435812

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

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®

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,428 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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®.

Detailed description

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®.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HEPLISAV and/or Placebo	Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
BIOLOGICAL	Engerix-B	Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2007-02-15
• Last updated: 2019-03-20
• Results posted: 2018-02-13

Locations

18 sites across 2 countries: Canada, Germany

Regulatory

• FDA-regulated drug study