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



Status:Completed
Conditions:Healthy Studies, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 70
Updated:3/22/2019
Start Date:April 2014
End Date:October 2015

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A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

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.


A subject must meet all of the following criteria to be eligible for the trial:

Inclusion Criteria:

- 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:

Exclusion Criteria:

- 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:

1. 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

2. Within 90 days: Blood products or immunoglobulin

3. 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
We found this trial at
40
sites
Columbus, Ohio 43212
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Akron, Ohio 44311
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Akron, OH
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Anderson, South Carolina 29621
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Anderson, SC
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Anderson, South Carolina 29621
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Anderson, SC
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Atlanta, Georgia
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Atlanta, GA
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Birmingham, Alabama 35211
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Birmingham, AL
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Centennial, Colorado 80112
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Centennial, CO
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Chandler, Arizona 85224
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Chandler, AZ
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Chandler, Arizona 85225
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Chandler, AZ
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Chicago, Illinois 60654
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Chicago, IL
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Cincinnati, Ohio 45249
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Cincinnati, OH
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Colorado Springs, Colorado 80922
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Colorado Springs, CO
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Council Bluffs, Iowa 51503
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Council Bluffs, IA
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Dallas, Texas 75231
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Dallas, TX
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Denver, Colorado 80239
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Denver, CO
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Edina, Minnesota 55435
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Edina, MN
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Elkhorn, Nebraska 68022
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Elkhorn, NE
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Evansville, Indiana 47714
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Evansville, IN
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Fremont, Nebraska 68025
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Fremont, NE
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Glendale, Arizona 85306
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Glendale, AZ
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Greer, South Carolina
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Greer, SC
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Henderson, Nevada 89052
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Henderson, NV
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Mesa, Arizona 85206
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Mesa, AZ
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Mesa, Arizona 85206
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Murray, Utah 84123
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Murray, UT
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Omaha, Nebraska 68130
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Omaha, NE
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Phoenix, Arizona 85282
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Phoenix, AZ
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Phoenix, Arizona 85282
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Phoenix, Arizona 85282
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Pinellas Park, Florida 33781
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Pinellas Park, FL
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Plano, TX
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Saint Louis, Missouri 63151
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Saint Louis, MO
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San Antonio, Texas
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San Antonio, TX
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Santa Rosa, California 95405
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Santa Rosa, CA
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Scottsdale, Arizona 85251
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Scottsdale, AZ
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Tempe, Arizona 85283
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Tempe, AZ
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Tucson, Arizona 85741
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Tucson, AZ
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Tucson, Arizona 85710
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Tucson, AZ
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Vista, California 92083
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Vista, CA
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