Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

Phase

3

Condition

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT01005407

DV2-HBV-16

Ages 40-70
All Genders
Accepts Healthy Volunteers

Study Summary

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Eligibility Criteria

Inclusion

Inclusion Criteria:

be 40 - 70 years of age, inclusive
be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis Bsurface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg),and human immunodeficiency virus (HIV)
be in good health in the opinion of the investigator, based upon medical history,physical examination, and laboratory evaluation
if female of childbearing potential, agree to consistently use a highly effectivemethod of birth control from screening visit through the treatment phase, for up to 28days after the last injection

Exclusion

Exclusion Criteria:

if female of childbearing potential, is pregnant, breastfeeding, or planning apregnancy
has a history of or is considered by the investigator to be at high risk for recentexposure to HBV or HIV; for example, current intravenous drug use or has unprotectedsex with known HBV/HIV positive partner
has a known history of autoimmune disease
has previously received any hepatitis B vaccine (approved or investigational)

Study Design

February 01, 2010

May 31, 2011

Study Description

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Connect with a study center

Mount Pearl, Newfoundland and Labrador
Canada
Site Not Available
Toronto, Ontario
Canada
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Montreal, Quebec
Canada
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Huntsville, Alabama
United States
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San Diego, California
United States
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Santa Ana, California
United States
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Denver, Colorado
United States
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Melbourne, Florida
United States
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Pinellas Park, Florida
United States
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Atlanta, Georgia
United States
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Chicago, Illinois
United States
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Peoria, Illinois
United States
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South Bend, Indiana
United States
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Rockville, Maryland
United States
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Brooklyn Center, Minnesota
United States
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Edina, Minnesota
United States
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Kansas City, Missouri
United States
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Saint Louis, Missouri
United States
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St. Louis, Missouri
United States
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Rochester, New York
United States
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Cincinnati, Ohio
United States
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Erie, Pennsylvania
United States
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Grove City, Pennsylvania
United States
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Jefferson Hills, Pennsylvania
United States
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Pittsburgh, Pennsylvania
United States
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Upper Saint Clair, Pennsylvania
United States
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Upper St. Clair, Pennsylvania
United States
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Anderson, South Carolina
United States
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Greer, South Carolina
United States
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Nashville, Tennessee
United States
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Dallas, Texas
United States
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Katy, Texas
United States
Site Not Available
San Antonio, Texas
United States
Site Not Available
Norfolk, Virginia
United States
Site Not Available

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