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

Tracking Information

First Received Date ^ICMJE

February 13, 2007

Last Updated Date

January 18, 2008

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Portion of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)

Change History

Complete list of historical versions of study NCT00435812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rates of adverse events and local and systemic reactions to injections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability through Week 28

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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®

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

Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.

This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available HBV vaccine, Engerix-B®, in subjects 11 to 55 years old. About 1,740 subjects will be included in the study. Once subjects have been 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
Biological: Hepatitis B Vaccine (Recombinant)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

2433

Estimated Completion Date

March 2008

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

11 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00435812

Responsible Party

Eduardo Martins, MD, DPhil / Vice President, Clinical Development, Dynavax Technologies Corporation

Study ID Numbers ^ICMJE

DV2-HBV-10

Study Sponsor ^ICMJE

Dynavax Technologies Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Eduardo B. Martins, MD, DPhil

Dynavax Technologies Corporation

Information Provided By

Dynavax Technologies Corporation

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP