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

Dynavax Technologies Corporation

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Biological: HEPLISAV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511095

DV2-HBV-14

Details and patient eligibility

About

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.

Full 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™.

Enrollment: 207 patients

Sex: All

Ages: 11 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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207 participants in 1 patient group

HEPLISAV

Experimental group

Description:

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

Treatment:

Biological: HEPLISAV