Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

July 6, 2020 updated by: VBI Vaccines Inc.

A Phase 3 Double-Blind Randomized Controlled Trial 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 (PROTECT)

This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.

Study Type

Interventional

Enrollment (Actual)

1607

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
      • Quebec, Canada
        • CHU de Québec Université Laval
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Children's Hospital Research Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Canadian Center for Vaccinology
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Hospital
      • Sudbury, Ontario, Canada, P3A 1W8
        • Medicore Research Inc
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre
  • Finland
      • Espoo, Finland
        • Espoo Vaccine Research Clinic
      • Helsinki, Finland
        • Helsinki South Vaccine Research Clinic
      • Järvenpää, Finland
        • Järvenpää Vaccine Research Clinic
      • Kokkola, Finland
        • Kokkola Vaccine Research Clinic
      • Oulu, Finland
        • Oulu Vaccine Research Clinic
      • Pori, Finland
        • Pori Vaccine Research Clinic
      • Seinäjoki, Finland
        • Seinäjoki Vaccine Research Clinic
      • Tampere, Finland
        • University of Tampere
      • Tampere, Finland
        • Tampere Vaccine Research Clinic
      • Turku, Finland
        • Turku Vaccine Research Clinic
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Accel Research Sites
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
    • 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 Atlanta
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Utah
      • Salt Lake City, Utah, United States, 84088
        • Advanced Clinical Research

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any gender.
  • Age ≥ 18 years
  • In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3
  • If female, either is not of childbearing potential or is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study
  • Able and willing to give consent.

Exclusion Criteria:

  • Previous vaccination with any Hep B vaccine (licensed or experimental).
  • Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are allowed).
  • Known 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 weeks 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 (Engerix-B® or Sci-B-Vac®)
  • Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method
  • Immediate family members of study center staff (parents, sibling, children)
  • Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers at screening
  • 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 at screening
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Any laboratory test abnormality that would be considered of Grade 1 severity and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
  • Diagnosis of advanced stage heart failure or Unstable Angina.

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® Hepatitis B Vaccination
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination
ACTIVE_COMPARATOR: Engerix-B® Hepatitis B Vaccination
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
Time Frame: Day 196
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be > - 5%.
Day 196
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
Time Frame: Day 196
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be > 5%.
Day 196

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 13, 2017

Primary Completion (ACTUAL)

April 8, 2019

Study Completion (ACTUAL)

April 8, 2019

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sci-B-Vac-001
  • 2017-001819-36 (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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