Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.

Key facts

Study ID

NCT02117934

Run by

Dynavax Technologies Corporation

People needed

8374

Starts

2014-04-01

Expected to finish

2015-10-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be 18-70 years of age, inclusive
• Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
• If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
• Able and willing to provide informed consent
• A subject with any one of the following criteria is not eligible for the trial:

You may not qualify if…

• Previous receipt of any hepatitis B vaccine
• History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
• History of autoimmune disorder
• History of sensitivity to any component of study vaccines
• Has received the following prior to the first injection:
• Within 28 days:
• Any vaccine
• Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
• Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
• Any other investigational medicinal agent
• Within 90 days: Blood products or immunoglobulin
• At any time: An injection of DNA plasmids or oligonucleotide
• If female: Pregnant, nursing, or planning to become pregnant during the trial
• Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
• Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments

Where it is running

• Clinical Research Advantage, Inc. — Birmingham, Alabama, United States
• Clinical Research Advantage, Inc. — Chandler, Arizona, United States
• Radiant Research — Chandler, Arizona, United States
• Clinical Research Advantage, Inc. — Glendale, Arizona, United States
• Clinical Research Advantage, Inc. — Mesa, Arizona, United States
• Clinical Research Advantage, Inc. — Mesa, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Clinical Research Advantage, Inc. — Tempe, Arizona, United States
• Radiant Research — Tucson, Arizona, United States
• Clinical Research Advantage, Inc. — Tucson, Arizona, United States
• Radiant Research — Santa Rosa, California, United States
• Clinical Research Advantage, Inc. — Vista, California, United States
• Clinical Research Advantage, Inc. — Centennial, Colorado, United States
• Clinical Research Advantage, Inc. — Colorado Springs, Colorado, United States
• Radiant Research — Denver, Colorado, United States
• Radiant Research — Pinellas Park, Florida, United States
• Radiant Research — Atlanta, Georgia, United States
• Radiant Research — Chicago, Illinois, United States
• Clinical Research Advantage, Inc — Evansville, Indiana, United States
• Clinical Research Advantage, Inc. — Council Bluffs, Iowa, United States
• Radiant Research — Edina, Minnesota, United States
• Radiant Research — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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