Lot-to-lot Consistency of Sci-B-Vac™ in Adults
A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
2 other identifiers
interventional
2,838
6 countries
26
Brief Summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2017
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedResults Posted
Study results publicly available
October 14, 2020
CompletedMarch 25, 2021
March 1, 2021
1.8 years
November 23, 2017
September 21, 2020
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
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 \[0.67, 1.5\].
4 weeks after third vaccination (Study Day 196)
Secondary Outcomes (2)
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)
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Day of vaccine administration and six subsequent days
Study Arms (4)
Sci-B-Vac Lot A Hep B Vaccination
EXPERIMENTALSci-B-Vac Lot A Hepatitis B Vaccination
Sci-B-Vac Lot B Hep B Vaccination
EXPERIMENTALSci-B-Vac Lot B Hepatitis B Vaccination
Sci-B-Vac Lot C Hep B Vaccination
EXPERIMENTALSci-B-Vac Lot C Hepatitis B Vaccination
Comparator: ENGERIX-B Hep B Vaccination
ACTIVE COMPARATORActive Comparator: ENGERIX-B Hepatitis B Vaccination
Interventions
Hepatitis B Vaccination
Eligibility Criteria
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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Accel Research Sites
Birmingham, Alabama, 35216, United States
Clinical Research Consortium Arizona, LLC
Tempe, Arizona, 85283, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Ruane Clinical Research Group Inc
Los Angeles, California, 90036, United States
CareOne Research
North Hollywood, California, 91606, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Suncoast Research Group
Miami, Florida, 33135, United States
Clinical Research Altanta
Atlanta, Georgia, 30281, United States
Advanced Clinical Research (ACR)
Boise, Idaho, 83642, United States
Montana Medical Research, LLC
Missoula, Montana, 59808, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Advanced Clinical Research (ACR)
Salt Lake City, Utah, 84088, 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
Related Publications (1)
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.
PMID: 34636914DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vlad Popovic
- Organization
- VBI Vaccines, Inc.
Study Officials
- STUDY DIRECTOR
Francisco Diaz-Mitoma, MD, PhD
VBI Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2017
First Posted
January 24, 2018
Study Start
December 14, 2017
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
March 25, 2021
Results First Posted
October 14, 2020
Record last verified: 2021-03