Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

Completed · Phase 3

Conditions studied: Hepatitis B Vaccines

In brief

This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.

Key facts

Study ID

NCT03393754

Run by

VBI Vaccines Inc.

People needed

1607

Starts

2017-12-13

Expected to finish

2019-04-08

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any gender.
• Age ≥ 18 years
• In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3
• If female, either is not of childbearing potential or is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study
• Able and willing to give consent.

You may not qualify if…

• Previous vaccination with any Hep B vaccine (licensed or experimental).
• Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are allowed).
• Known 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 weeks 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 (Engerix-B® or Sci-B-Vac®)
• Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method
• Immediate family members of study center staff (parents, sibling, children)
• Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers at screening
• 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 at screening
• Uncontrolled diabetes mellitus
• Uncontrolled hypertension
• Any laboratory test abnormality that would be considered of Grade 1 severity and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
• Diagnosis of advanced stage heart failure or Unstable Angina.

Where it is running

• Accel Research Sites — Birmingham, Alabama, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Avail Clinical Research — DeLand, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• Clinical Research Atlanta — Atlanta, Georgia, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Rapid Medical Research — Cleveland, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Advanced Clinical Research — Salt Lake City, Utah, United States
• Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium
• BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Canadian Center for Vaccinology — Halifax, Nova Scotia, Canada
• Medicore Research Inc — Greater Sudbury, Ontario, Canada
• Ottawa Hospital — Ottawa, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• CHU de Québec Université Laval — Québec, Quebec, Canada
• Espoo Vaccine Research Clinic — Espoo, Finland
• Helsinki South Vaccine Research Clinic — Helsinki, Finland
• Järvenpää Vaccine Research Clinic — Jarvenpaa, Finland
• Kokkola Vaccine Research Clinic — Kokkola, Finland
• Oulu Vaccine Research Clinic — Oulu, Finland
• Pori Vaccine Research Clinic — Pori, Finland
• Seinäjoki Vaccine Research Clinic — Seinäjoki, Finland

Full record on ClinicalTrials.gov

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