Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Hepatitis B Vaccines Clinical Trial

Official title:

A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408730
• Other study ID #: Sci-B-Vac-002
• Secondary ID: 2017-001820-22
• Status: Completed
• Phase: Phase 3
• Start date: December 14, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: March 2021
• Source: VBI Vaccines Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults

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 information / eligibility

• Status: Completed
• Enrollment: 2838
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B Vaccines

Intervention

Biological:
• Hepatitis B Vaccination
Hepatitis B Vaccination

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Canada	Manna Montreal	Montreal	Quebec
Canada	Manna Research Quebec	Quebec City	Quebec
Canada	Medicore Research Inc	Sudbury	Ontario
Canada	Manna Toronto	Toronto	Ontario
Finland	University of Tampere	Tampere
Germany	Medizinishe Hochschule Hannover	Hannover
United Kingdom	Bristol Royal Hospital for Children	Bristol
United Kingdom	St. George's University Hospital NHS Foundation Trust	London
United Kingdom	Oxford University	Oxford	Oxfordshire
United Kingdom	Southampton General Hospital	Southampton
United States	Anaheim Clinical Trials	Anaheim	California
United States	Clinical Research Altanta	Atlanta	Georgia
United States	Accel Research Sites	Birmingham	Alabama
United States	Advanced Clinical Research (ACR)	Boise	Idaho
United States	Rapid Medical Research	Cleveland	Ohio
United States	Aventiv Research Inc	Columbus	Ohio
United States	Avail Clinical Research	DeLand	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Ruane Clinical Research Group Inc	Los Angeles	California
United States	Suncoast Research Group	Miami	Florida
United States	Montana Medical Research, LLC	Missoula	Montana
United States	CareOne Research	North Hollywood	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Advanced Clinical Research (ACR)	Salt Lake City	Utah
United States	Clinical Research Consortium Arizona, LLC	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VBI Vaccines Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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®	4 weeks after third vaccination (Study Day 196)
Secondary	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.	Day of vaccine administration and six subsequent days