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

Dynavax Technologies Corporation207 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

207

Conditions

Hepatitis B

Interventions

HEPLISAVBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Percentage of Participants With Local and Systemic Post-injection Reaction Rates

Local and Systemic post-injection reactions.

Time frame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4

Secondary Outcomes

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

Time frame: Weeks 4, 8, 12 and 28

Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28

Measurement of Serum GMC

Time frame: Weeks 4, 8, 12, and 28

Data from ClinicalTrials.gov

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