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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: HEPLISAV and/or Placebo; Biological: Engerix-B

• Registration Number: NCT00435812
• Lead Sponsor: Dynavax Technologies Corporation

Brief 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®.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Disposition First Submitted: 2014-06-16
• Disposition First Submitted QC: 2014-06-16
• Disposition First Posted: 2014-06-19
• Results First Submitted: 2017-12-08
• Results First Submitted QC: 2018-01-15
• Results First Posted: 2018-02-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2428

Inclusion Criteria

• Willing and able to give written informed consent
• Is serum negative for HBV antibodies

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Any previous HBV infection
• Previous vaccination with any HBV vaccine (1 or more doses)
• Any autoimmune disease
• Received any blood products or antibodies within 3 months prior to study entry
• Ever received an injection with DNA plasmids or oligonucleotides
• Received any vaccines within 4 weeks prior to study entry
• Received any other investigational medicinal agent within 4 weeks prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEPLISAV and/or Placebo	HEPLISAV and/or Placebo	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Engerix-B	Engerix-B	1.0 mL Engerix-B

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Seroprotective Immune Response	Week 12 for HEPLISAV and Week 28 for Engerix-B	Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Local and Systemic Reactions to Injections	Within 7 days post-injection for Post Injection Reactions