Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Completed · Phase 3

Conditions studied: Hepatitis B Vaccines

In brief

A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Key facts

Study ID

NCT03408730

Run by

VBI Vaccines Inc.

People needed

2838

Starts

2017-12-14

Expected to finish

2019-10-01

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any gender
• 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

You may not qualify if…

• Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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