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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HEPLISAV and/or Placebo
Engerix-B
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Immunostimulatory sequence (ISS)

Eligibility Criteria

11 Years - 55 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEPLISAV and/or Placebo

Engerix-B

Arm Description

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)

1.0 mL Engerix-B

Outcomes

Primary Outcome Measures

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®)

Secondary Outcome Measures

Percentage of Participants With Local and Systemic Reactions to Injections

Full Information

First Posted
February 13, 2007
Last Updated
March 18, 2019
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00435812
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Immunostimulatory sequence (ISS)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEPLISAV and/or Placebo
Arm Type
Experimental
Arm Description
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Arm Title
Engerix-B
Arm Type
Active Comparator
Arm Description
1.0 mL Engerix-B
Intervention Type
Biological
Intervention Name(s)
HEPLISAV and/or Placebo
Other Intervention Name(s)
HEPLISAV, Hepatitis B vaccine (recombinant), adjuvanted
Intervention Description
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
Intervention Type
Biological
Intervention Name(s)
Engerix-B
Other Intervention Name(s)
Hepatitis B vaccine (recombinant)
Intervention Description
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Primary Outcome Measure Information:
Title
Percentage of Subjects With Seroprotective Immune Response
Description
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 Outcome Measure Information:
Title
Percentage of Participants With Local and Systemic Reactions to Injections
Time Frame
Within 7 days post-injection for Post Injection Reactions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Tyler Martin, Sr, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
City
Edmonton
State/Province
Alberta
Country
Canada
City
Surrey
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Sarnia
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
City
Montréal
State/Province
Quebec
Country
Canada
City
Québec
State/Province
Quebec
Country
Canada
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Leipzig
Country
Germany
City
Magdeburg
Country
Germany
City
Munich
Country
Germany
City
Ulm
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.dynavax.com
Description
Dynavax Webpage

Learn more about this trial

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

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