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

Dynavax Technologies Corporation

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: Engerix-B

Biological: HEPLISAV and/or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435812

DV2-HBV-10

2006-006743-31 (EudraCT Number)

Details and patient eligibility

About

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®.

Full 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®.

Enrollment

2,428 patients

Sex

All

Ages

11 to 55 years old

Volunteers

Accepts Healthy Volunteers

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