Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

Hepatitis B Clinical Trial

Official title:

An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511095
• Other study ID #: DV2-HBV-14
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: April 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 further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

Description:

This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.

Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 2008
• Est. primary completion date: October 2007
• 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

• Women of childbearing potential must be willing to consistently use a highly effective method of birth control

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Any previous HBV infection

• Previous vaccination (1 or more doses) with any HBV vaccine

• Any previous autoimmune diseases

• Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)

• 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
Intramuscular (IM) injections 0.5mL on Day 0 and Week 4

Locations

Country	Name	City	State
United States	Beeghley Medical Park	Boardman	Ohio
United States	Metropolitan Research	Fairfax	Virginia
United States	Family Healthcare Partners	Grove City	Pennsylvania
United States	Pediatric Alliance Southwestern	Pittsburgh	Pennsylvania
United States	Primary Physicians Research	Pittsburgh	Pennsylvania
United States	Family Practice Medical Associates South	Upper Saint Clair	Pennsylvania
United States	The Washington Hospital Family Medicine	Washington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Local and Systemic Post-injection Reaction Rates	Local and Systemic post-injection reactions.	Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Secondary	Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg = 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.	Seroprotective Immune Response	Weeks 4, 8, 12 and 28
Secondary	Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28	Measurement of Serum GMC	Weeks 4, 8, 12, and 28

External Links

•   Dynavax Webpage