Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
- Conditions
- Hepatitis B Vaccines
- Interventions
- Biological: Hepatitis B Vaccination
- Registration Number
- NCT03393754
- Lead Sponsor
- VBI Vaccines Inc.
- Brief Summary
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.
- Detailed Description
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 adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1607
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sci-B-Vac® Hepatitis B Vaccination Hepatitis B Vaccination Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168. Engerix-B® Hepatitis B Vaccination Hepatitis B Vaccination Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
- Primary Outcome Measures
Name Time Method Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 Day 196 To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be \> 5%.
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 Day 196 To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be \> - 5%.
- Secondary Outcome Measures
Name Time Method Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) Day of vaccine administration and six subsequent days Analysis of local and systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old.
Trial Locations
- Locations (27)
BC Children's Hospital Research Institute
🇨🇦Vancouver, British Columbia, Canada
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Clinical Research Atlanta
🇺🇸Atlanta, Georgia, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
CHU de Québec Université Laval
🇨🇦Quebec, Canada
Kokkola Vaccine Research Clinic
🇫🇮Kokkola, Finland
Seinäjoki Vaccine Research Clinic
🇫🇮Seinäjoki, Finland
Suncoast Research Group
🇺🇸Miami, Florida, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Canadian Center for Vaccinology
🇨🇦Halifax, Nova Scotia, Canada
Universitair Ziekenhuis Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Medicore Research Inc
🇨🇦Sudbury, Ontario, Canada
Advanced Clinical Research
🇺🇸Salt Lake City, Utah, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Helsinki South Vaccine Research Clinic
🇫🇮Helsinki, Finland
Pori Vaccine Research Clinic
🇫🇮Pori, Finland
Espoo Vaccine Research Clinic
🇫🇮Espoo, Finland
Järvenpää Vaccine Research Clinic
🇫🇮Järvenpää, Finland
Oulu Vaccine Research Clinic
🇫🇮Oulu, Finland
University of Tampere
🇫🇮Tampere, Finland
Tampere Vaccine Research Clinic
🇫🇮Tampere, Finland
Turku Vaccine Research Clinic
🇫🇮Turku, Finland
Accel Research Sites
🇺🇸Birmingham, Alabama, United States