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

Phase 2

Completed

• Conditions: Hepatitis B
• Interventions: Biological: HEPLISAV

• 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

Arm && Interventions

Group	Intervention	Description
HEPLISAV	HEPLISAV	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL

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

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

Pediatric Alliance Southwestern; 🇺🇸 Pittsburgh, Pennsylvania, United States

Primary Physicians Research; 🇺🇸 Pittsburgh, Pennsylvania, United States