Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2838 participants
INTERVENTIONAL
2017-12-14
2019-10-01
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
TRIPLE
Study Groups
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Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot A Hepatitis B Vaccination
Hepatitis B Vaccination
Hepatitis B Vaccination
Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
Hepatitis B Vaccination
Hepatitis B Vaccination
Sci-B-Vac Lot C Hep B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
Hepatitis B Vaccination
Hepatitis B Vaccination
Comparator: ENGERIX-B Hep B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Hepatitis B Vaccination
Hepatitis B Vaccination
Interventions
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Hepatitis B Vaccination
Hepatitis B Vaccination
Eligibility Criteria
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Inclusion Criteria
* Age 18-45 years
* Healthy, as determined by a physical examination and values of laboratory tests
* If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method
* Able and willing to give informed consent
Exclusion Criteria
* Treatment by immunosuppressant within 30 days of enrollment
* History of immunological function impairment
* Pregnancy or breastfeeding
* Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment
* Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment
* Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period
* Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment
* Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period
* Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease.
* Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
* History of allergic reactions or anaphylactic reaction to any vaccine component
* Unwilling, or unable in the opinion of the investigator, to comply with study requirements
* Immediate family members of study center staff
* Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers
* Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured
* Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening
* Renal impairment with Glomerular Filtration Rate (GFR) \<90 mL/min/ 1.73 m2 at screening
* BMI ≥ 35
* Uncontrolled hypertension
* Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening
* Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.
18 Years
45 Years
ALL
Yes
Sponsors
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VBI Vaccines Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Francisco Diaz-Mitoma, MD, PhD
Role: STUDY_DIRECTOR
VBI Vaccines
Locations
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Accel Research Sites
Birmingham, Alabama, United States
Clinical Research Consortium Arizona, LLC
Tempe, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Ruane Clinical Research Group Inc
Los Angeles, California, United States
CareOne Research
North Hollywood, California, United States
Avail Clinical Research
DeLand, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Clinical Research Altanta
Atlanta, Georgia, United States
Advanced Clinical Research (ACR)
Boise, Idaho, United States
Montana Medical Research, LLC
Missoula, Montana, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Rapid Medical Research
Cleveland, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Advanced Clinical Research (ACR)
Salt Lake City, Utah, United States
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Medicore Research Inc
Greater Sudbury, Ontario, Canada
Manna Toronto
Toronto, Ontario, Canada
Manna Montreal
Montreal, Quebec, Canada
Manna Research Quebec
Québec, Quebec, Canada
University of Tampere
Tampere, , Finland
Medizinishe Hochschule Hannover
Hanover, , Germany
Oxford University
Oxford, Oxfordshire, United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
St. George's University Hospital NHS Foundation Trust
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Vesikari T, Finn A, van Damme P, Leroux-Roels I, Leroux-Roels G, Segall N, Toma A, Vallieres G, Aronson R, Reich D, Arora S, Ruane PJ, Cone CL, Manns M, Cosgrove C, Faust SN, Ramasamy MN, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson D, Popovic V, Diaz-Mitoma F; CONSTANT Study Group. Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128652. doi: 10.1001/jamanetworkopen.2021.28652.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2017-001820-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Sci-B-Vac-002
Identifier Type: -
Identifier Source: org_study_id
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