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

Phase 2

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00511095
• Lead Sponsor: Dynavax Technologies Corporation

Brief 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.

Detailed 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™.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-03
• Primary Completion: 2007-10
• Study Completion: 2008-03
• Disposition First Submitted: 2010-06-17
• Disposition First Submitted QC: 2010-06-17
• Disposition First Posted: 2010-06-22
• Results First Submitted: 2017-03-01
• Results First Submitted QC: 2017-03-01
• Results First Posted: 2017-04-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Local and Systemic Post-injection Reaction Rates	Within 7 days post-injection for post-injection reactions at Week 0 and Week 4	Local and Systemic post-injection reactions.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.	Weeks 4, 8, 12 and 28	Seroprotective Immune Response
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28	Weeks 4, 8, 12, and 28	Measurement of Serum GMC

Trial Locations

Locations (7)

Beeghley Medical Park; 🇺🇸 Boardman, Ohio, 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, United States

Metropolitan Research; 🇺🇸 Fairfax, Virginia, United States