Clinical trial NCT00435812: Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Official title: 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: HBV vaccine
Hepatitis B vaccine
Hepatitis B
Hepatitis
HBV
Immunostimulatory sequence (ISS)
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 2428
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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®.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With Seroprotective Immune Response
timeFrame: Week 12 for HEPLISAV and Week 28 for Engerix-B
Secondary outcomes:
measure: Percentage of Participants With Local and Systemic Reactions to Injections
timeFrame: Within 7 days post-injection for Post Injection Reactions
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Ottawa
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Charlottetown
country: Canada
state: Prince Edward Island
city: Montréal
country: Canada
state: Quebec
city: Québec
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Munich
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: Dynavax Technologies Corporation
name: J. Tyler Martin, Sr, MD
role: STUDY_DIRECTOR
References: