NCT03393754

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,607

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach
4 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

November 23, 2017

Results QC Date

June 15, 2020

Last Update Submit

July 6, 2020

Conditions

Hepatitis B Vaccines

Keywords

Hepatitis B Vaccines

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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 Outcomes (1)

  • Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)

    Day of vaccine administration and six subsequent days

Study Arms (2)

Sci-B-Vac® Hepatitis B Vaccination

EXPERIMENTAL

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

Biological: Hepatitis B Vaccination

Engerix-B® Hepatitis B Vaccination

ACTIVE COMPARATOR

Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.

Biological: Hepatitis B Vaccination

Interventions

Hepatitis B VaccinationBIOLOGICAL

Prophylactic Hepatitis B Vaccination

Engerix-B® Hepatitis B VaccinationSci-B-Vac® Hepatitis B Vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any gender.
  • Age ≥ 18 years

You may not qualify if:

  • 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.
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Accel Research Sites

Birmingham, Alabama, 35216, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Clinical Research Atlanta

Atlanta, Georgia, 30281, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Advanced Clinical Research

Salt Lake City, Utah, 84088, United States

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Location

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Location

Medicore Research Inc

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

CHU de Québec Université Laval

Québec, Quebec, Canada

Location

Espoo Vaccine Research Clinic

Espoo, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, Finland

Location

Järvenpää Vaccine Research Clinic

Jarvenpaa, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, Finland

Location

Oulu Vaccine Research Clinic

Oulu, Finland

Location

Pori Vaccine Research Clinic

Pori, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, Finland

Location

Tampere Vaccine Research Clinic

Tampere, Finland

Location

University of Tampere

Tampere, Finland

Location

Turku Vaccine Research Clinic

Turku, Finland

Location

Related Publications (3)

  • Berthoud TK, Ahmed T, Nadia W, Petrov I, Yang L, Colledge D, Hammond R, Soare C, Ontsouka B, Plaskin D, Anderson DE, Diaz-Mitoma F. A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers. Vaccine. 2025 Jan 1;43(Pt 2):126513. doi: 10.1016/j.vaccine.2024.126513. Epub 2024 Nov 12.

    PMID: 39536477DERIVED

  • Talbird SE, Anderson SA, Nossov M, Beattie N, Rak AT, Diaz-Mitoma F. Cost-effectiveness of a 3-antigen versus single-antigen vaccine for the prevention of hepatitis B in adults in the United States. Vaccine. 2023 May 26;41(23):3506-3517. doi: 10.1016/j.vaccine.2023.04.022. Epub 2023 May 3.

    PMID: 37147201DERIVED

  • Vesikari T, Langley JM, Segall N, Ward BJ, Cooper C, Poliquin G, Smith B, Gantt S, McElhaney JE, Dionne M, van Damme P, Leroux-Roels I, Leroux-Roels G, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson DE, Popovic V, Diaz-Mitoma F; PROTECT Study Group. Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2021 Sep;21(9):1271-1281. doi: 10.1016/S1473-3099(20)30780-5. Epub 2021 May 11.

    PMID: 33989539DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Vlad Popovic
Organization
VBI Vaccines, Inc.
vpopovic@vbivaccines.com
416-418-4713

Study Officials

  • Francisco Diaz-Mitoma, MD, PhD

    VBI Vaccines

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

January 8, 2018

Study Start

December 13, 2017

Primary Completion

April 8, 2019

Study Completion

April 8, 2019

Last Updated

July 17, 2020

Results First Posted

July 7, 2020

Record last verified: 2020-07

Locations

US(10)BE(1)CA(7)FI(10)