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

Hepatitis B Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435812
• Other study ID #: DV2-HBV-10
• Secondary ID: 2006-006743-31
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2428
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24
• Engerix-B
Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®)	Week 12 for HEPLISAV and Week 28 for Engerix-B
Secondary	Percentage of Participants With Local and Systemic Reactions to Injections		Within 7 days post-injection for Post Injection Reactions

External Links

•   Dynavax Webpage