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

Dynavax Technologies Corporation2,428 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,428

Conditions

Hepatitis B

Interventions

HEPLISAV and/or PlaceboBIOLOGICAL

Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24

Engerix-BBIOLOGICAL

Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Eligibility

Sex: ALLMin age: 11 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

Surrey, British Columbia, Canada

Unnamed facility

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Percentage of Subjects With Seroprotective Immune Response

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®)

Time frame: Week 12 for HEPLISAV and Week 28 for Engerix-B

Secondary Outcomes

Percentage of Participants With Local and Systemic Reactions to Injections

Time frame: Within 7 days post-injection for Post Injection Reactions

Data from ClinicalTrials.gov

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