Lot-to-lot Consistency of Sci-B-Vac™ in Adults
- Conditions
- Hepatitis B Vaccines
- Interventions
- Biological: Hepatitis B Vaccination
- Registration Number
- NCT03408730
- Lead Sponsor
- VBI Vaccines Inc.
- Brief Summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
- Detailed Description
The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2838
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sci-B-Vac Lot B Hep B Vaccination Hepatitis B Vaccination Sci-B-Vac Lot B Hepatitis B Vaccination Sci-B-Vac Lot C Hep B Vaccination Hepatitis B Vaccination Sci-B-Vac Lot C Hepatitis B Vaccination Sci-B-Vac Lot A Hep B Vaccination Hepatitis B Vaccination Sci-B-Vac Lot A Hepatitis B Vaccination Comparator: ENGERIX-B Hep B Vaccination Hepatitis B Vaccination Active Comparator: ENGERIX-B Hepatitis B Vaccination
- Primary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) 4 weeks after third vaccination (Study Day 196) To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of \[0.67, 1.5\].
- 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.
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2) 4 weeks after third vaccination (Study Day 196) The difference in proportions \[SPR(Sci-B-Vac®)-SPR(Engerix-B®)\] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was \> 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B®
Trial Locations
- Locations (25)
Universitair Ziekenhuis Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Oxford University
🇬🇧Oxford, Oxfordshire, United Kingdom
University of Tampere
🇫🇮Tampere, Finland
Ruane Clinical Research Group Inc
🇺🇸Los Angeles, California, United States
Clinical Research Altanta
🇺🇸Atlanta, Georgia, United States
Manna Toronto
🇨🇦Toronto, Ontario, Canada
Avail Clinical Research
🇺🇸DeLand, Florida, United States
CareOne Research
🇺🇸North Hollywood, California, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Bristol Royal Hospital for Children
🇬🇧Bristol, United Kingdom
Advanced Clinical Research (ACR)
🇺🇸Salt Lake City, Utah, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Medicore Research Inc
🇨🇦Sudbury, Ontario, Canada
Montana Medical Research, LLC
🇺🇸Missoula, Montana, United States
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Medizinishe Hochschule Hannover
🇩🇪Hannover, Germany
Suncoast Research Group
🇺🇸Miami, Florida, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Clinical Research Consortium Arizona, LLC
🇺🇸Tempe, Arizona, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Manna Montreal
🇨🇦Montreal, Quebec, Canada
Manna Research Quebec
🇨🇦Quebec City, Quebec, Canada
St. George's University Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Accel Research Sites
🇺🇸Birmingham, Alabama, United States