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

NCT ID: NCT03393754

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1607 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2019-04-08

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.

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.

Conditions

Hepatitis B Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hepatitis B Vaccination

Intervention Type: BIOLOGICAL

Prophylactic Hepatitis B Vaccination

Engerix-B® Hepatitis B Vaccination

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

Group Type: ACTIVE_COMPARATOR

Hepatitis B Vaccination

Intervention Type: BIOLOGICAL

Prophylactic Hepatitis B Vaccination

Interventions

Hepatitis B Vaccination

Prophylactic Hepatitis B Vaccination

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Any gender.
• Age ≥ 18 years

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VBI Vaccines Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Diaz-Mitoma, MD, PhD

Role: STUDY_DIRECTOR

VBI Vaccines

Locations

Accel Research Sites

Birmingham, Alabama, United States

Anaheim Clinical Trials

Anaheim, California, United States

Avail Clinical Research

DeLand, Florida, United States

Suncoast Research Group

Miami, Florida, United States

Clinical Research Atlanta

Atlanta, Georgia, United States

Advanced Clinical Research

Boise, Idaho, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Rapid Medical Research

Cleveland, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Advanced Clinical Research

Salt Lake City, Utah, United States

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Medicore Research Inc

Greater Sudbury, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

CHU de Québec Université Laval

Québec, Quebec, Canada

Espoo Vaccine Research Clinic

Espoo, , Finland

Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Järvenpää Vaccine Research Clinic

Järvenpää, , Finland

Kokkola Vaccine Research Clinic

Kokkola, , Finland

Oulu Vaccine Research Clinic

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

University of Tampere

Tampere, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Countries

United States; Belgium; Canada; Finland

References

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.

Reference Type: DERIVED

PMID: 39536477 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37147201 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33989539 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001819-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Sci-B-Vac-001

Identifier Type: -

Identifier Source: org_study_id