Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
NCT ID: NCT02117934
Last Updated: 2019-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8374 participants
INTERVENTIONAL
2014-04-30
2015-10-31
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
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
HEPLISAV
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Engerix-B
1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.
Engerix-B
Intramuscular injections at Week 0, Week 4, and Week 24
Interventions
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HEPLISAV
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Engerix-B
Intramuscular injections at Week 0, Week 4, and Week 24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Janssen, MD
Role: STUDY_DIRECTOR
Dynavax Technologies Corporation
Locations
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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
Clinical Research Advantage, Inc.
Elkhorn, Nebraska, United States
Clinical Research Advantage, Inc.
Fremont, Nebraska, United States
Clinical Research Advantage, Inc.
Omaha, Nebraska, United States
Clinical Research Advantage, Inc.
Henderson, Nevada, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States
Radiant Research
Akron, Ohio, United States
Radiant Research
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Clinical Research Advantage, Inc.
Anderson, South Carolina, United States
Radiant Research
Anderson, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Radiant Research
Dallas, Texas, United States
Clinical Research Advantage, Inc.
Plano, Texas, United States
Radiant Research
San Antonio, Texas, United States
Radiant Research
Murray, Utah, United States
Countries
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References
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Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
Other Identifiers
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DV2-HBV-23
Identifier Type: -
Identifier Source: org_study_id
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