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

Completed · Phase 2

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT00511095

Run by

Dynavax Technologies Corporation

People needed

207

Starts

2007-06-01

Expected to finish

2008-03-01

Last updated by the study team

2019-04-30

Who can join

Age: 11 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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