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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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™.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HEPLISAV

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

Group Type EXPERIMENTAL

HEPLISAV

Intervention Type BIOLOGICAL

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

Interventions

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HEPLISAV

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes