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

March 3, 2021 updated by: VBI Vaccines Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2838

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium
        • Universitair Ziekenhuis Gent
  • Canada
    • Ontario
      • Sudbury, Ontario, Canada
        • Medicore Research Inc
      • Toronto, Ontario, Canada
        • Manna Toronto
    • Quebec
      • Montreal, Quebec, Canada
        • Manna Montreal
      • Quebec City, Quebec, Canada
        • Manna Research Quebec
  • Finland
      • Tampere, Finland
        • University of Tampere
  • Germany
      • Hannover, Germany
        • Medizinishe Hochschule Hannover
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Royal Hospital for Children
      • London, United Kingdom
        • St. George's University Hospital NHS Foundation Trust
      • Southampton, United Kingdom
        • Southampton General Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • Oxford University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Accel Research Sites
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium Arizona, LLC
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group Inc
      • North Hollywood, California, United States, 91606
        • CareOne Research
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research
      • Miami, Florida, United States, 33135
        • Suncoast Research Group
    • Georgia
      • Atlanta, Georgia, United States, 30281
        • Clinical Research Altanta
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research (ACR)
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center Of Nevada
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
      • Columbus, Ohio, United States, 43213
        • Aventiv Research Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Utah
      • Salt Lake City, Utah, United States, 84088
        • Advanced Clinical Research (ACR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot A Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination
EXPERIMENTAL: Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination
EXPERIMENTAL: Sci-B-Vac Lot C Hep B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination
ACTIVE_COMPARATOR: Comparator: ENGERIX-B Hep B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
Time Frame: 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].
4 weeks after third vaccination (Study Day 196)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
Time Frame: 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®
4 weeks after third vaccination (Study Day 196)
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Time Frame: 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.
Day of vaccine administration and six subsequent days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VBI Vaccines Inc.

Investigators

  • Study Director: Francisco Diaz-Mitoma, MD, PhD, VBI Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 14, 2017

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

October 1, 2019

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

January 22, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sci-B-Vac-002
  • 2017-001820-22 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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