Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
NCT ID: NCT01005407
Last Updated: 2019-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2452 participants
INTERVENTIONAL
2010-02-28
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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HEPLISAV and/or Placebo
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Engerix-B(1)
1.0 mL Engerix-B
Engerix-B
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Interventions
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HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Engerix-B
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface 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 effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection
Exclusion Criteria
* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
* has a known history of autoimmune disease
* has previously received any hepatitis B vaccine (approved or investigational)
40 Years
70 Years
ALL
Yes
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
San Diego, California, United States
Santa Ana, California, United States
Denver, Colorado, United States
Melbourne, Florida, United States
Pinellas Park, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
South Bend, Indiana, United States
Rockville, Maryland, United States
Brooklyn Center, Minnesota, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Erie, Pennsylvania, United States
Grove City, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Anderson, South Carolina, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Mount Pearl, Newfoundland and Labrador, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.
Other Identifiers
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DV2-HBV-16
Identifier Type: -
Identifier Source: org_study_id
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