Clinical trial NCT03408730: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B Vaccines
Keywords: Hepatitis B Vaccines
Lead sponsor: VBI Vaccines Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 2838
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind Randomized Controlled Trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
timeFrame: 4 weeks after third vaccination (Study Day 196)
Secondary outcomes:
measure: Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
timeFrame: 4 weeks after third vaccination (Study Day 196)
measure: Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Day of vaccine administration and six subsequent days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona, LLC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc
state: California
city: North Hollywood
country: United States
facility: CareOne Research
state: California
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Altanta
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research (ACR)
state: Idaho
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Salt Lake City
country: United States
facility: Advanced Clinical Research (ACR)
state: Utah
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Sudbury
country: Canada
facility: Medicore Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Manna Toronto
state: Ontario
city: Montreal
country: Canada
facility: Manna Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Manna Research Quebec
state: Quebec
city: Tampere
country: Finland
facility: University of Tampere
city: Hannover
country: Germany
facility: Medizinishe Hochschule Hannover
city: Oxford
country: United Kingdom
facility: Oxford University
state: Oxfordshire
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: London
country: United Kingdom
facility: St. George's University Hospital NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: VBI Vaccines
name: Francisco Diaz-Mitoma, MD, PhD
role: STUDY_DIRECTOR
References:
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.