Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Primary Purpose
Hepatitis B Vaccines
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hepatitis B Vaccination
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B Vaccines focused on measuring Hepatitis B Vaccines
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Accel Research Sites
- Clinical Research Consortium Arizona, LLC
- Anaheim Clinical Trials
- Ruane Clinical Research Group Inc
- CareOne Research
- Avail Clinical Research
- Suncoast Research Group
- Clinical Research Altanta
- Advanced Clinical Research (ACR)
- Montana Medical Research, LLC
- Clinical Research Center of Nevada
- Rapid Medical Research
- Aventiv Research Inc
- Lynn Health Science Institute
- Advanced Clinical Research (ACR)
- Universitair Ziekenhuis Gent
- Medicore Research Inc
- Manna Toronto
- Manna Montreal
- Manna Research Quebec
- University of Tampere
- Medizinishe Hochschule Hannover
- Oxford University
- Bristol Royal Hospital for Children
- St. George's University Hospital NHS Foundation Trust
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot C Hep B Vaccination
Comparator: ENGERIX-B Hep B Vaccination
Arm Description
Sci-B-Vac Lot A Hepatitis B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
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®
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03408730
Brief Title
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Official Title
A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VBI Vaccines Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Vaccines
Keywords
Hepatitis B Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double-blind Randomized Controlled Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2838 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sci-B-Vac Lot A Hep B Vaccination
Arm Type
Experimental
Arm Description
Sci-B-Vac Lot A Hepatitis B Vaccination
Arm Title
Sci-B-Vac Lot B Hep B Vaccination
Arm Type
Experimental
Arm Description
Sci-B-Vac Lot B Hepatitis B Vaccination
Arm Title
Sci-B-Vac Lot C Hep B Vaccination
Arm Type
Experimental
Arm Description
Sci-B-Vac Lot C Hepatitis B Vaccination
Arm Title
Comparator: ENGERIX-B Hep B Vaccination
Arm Type
Active Comparator
Arm Description
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccination
Intervention Description
Hepatitis B Vaccination
Primary Outcome Measure Information:
Title
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
Description
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].
Time Frame
4 weeks after third vaccination (Study Day 196)
Secondary Outcome Measure Information:
Title
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
Description
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®
Time Frame
4 weeks after third vaccination (Study Day 196)
Title
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Description
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.
Time Frame
Day of vaccine administration and six subsequent days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Diaz-Mitoma, MD, PhD
Organizational Affiliation
VBI Vaccines
Official's Role
Study Director
Facility Information:
Facility Name
Accel Research Sites
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Clinical Research Consortium Arizona, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Ruane Clinical Research Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
CareOne Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Clinical Research Altanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research (ACR)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Advanced Clinical Research (ACR)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Medicore Research Inc
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Manna Toronto
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Manna Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Manna Research Quebec
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
University of Tampere
City
Tampere
Country
Finland
Facility Name
Medizinishe Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Oxford University
City
Oxford
State/Province
Oxfordshire
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
Country
United Kingdom
Facility Name
St. George's University Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34636914
Citation
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.
Results Reference
derived
Learn more about this trial
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
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