Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

NCT04209400 | Completed Phase 3 Results DMC

• 1 other identifier: 38-13-040 RUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult subjects in Russia.

Conditions

Hepatitis B

Keywords

Sci-B-Vac®; Prophylactic vaccine; HepB vaccines; Phase 3; pre-S1; pre-S2; Surface antigen

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate

  Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL 30 days after the last of three vaccinations. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.

  Day 210

Secondary Outcomes (3)

• Seroprotection Rate

  Days 1, 28, 90, 180, 210

• Seroconversion Rate

  Days 1, 28, 90, 180

• Geometric Mean Concentrations (GMC) of HBs Antibodies

  Days 1, 28, 90, 180, and 210

Other Outcomes (4)

• Adverse Events: Local Reactions at the Injection Site- Incidence of Redness

  Day 1, Day 2, and Day 28

• Adverse Events: Local Reactions at the Injection Site - Incidence of Itch

  Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210

• Adverse Events: Local Reactions at the Injection Site - Incidence of Pain

  Days 1, 28, 180

Study Arms (2)

Sci-B-Vac®

EXPERIMENTAL

The 3-antigen HepB vaccine, Sci-B-Vac® contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac® was supplied in 1.0 ml vials.

Biological: Sci-B-Vac®

Engerix-B®

ACTIVE COMPARATOR

The single-antigen HepB vaccine, Engerix-B® (GSK), contains the small S recombinant protein. Engerix-B® was supplied in 1.0 ml vials.

Biological: Engerix-B®

Interventions

Sci-B-Vac® BIOLOGICAL

Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml

Sci-B-Vac®

Engerix-B® BIOLOGICAL

Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml

Engerix-B®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of written Informed Consent to participate in the study from the subject.
• Male or female between 18 and 45 years old without previous contact with hepatitis B virus (HBV).
• Good health condition based on full physical examination.
• Normal values of laboratory biochemical blood tests.
• Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core) antibodies, and HBs Antigen (HBsAg) on screening.
• Not pregnant and not breast-feeding.
• For men and women of reproductive age: consent for use of an effective contraception method, for example, an intrauterine device, oral contraceptive, hypodermic implant or double barrier method (a condom with contraceptive sponge or contraceptive suppository) throughout the entire study.

You may not qualify if:

• Congenital or inherited immunodeficiency disorder in family history.
• Information of a serious blood disorder, cardiac disorder, or tumour.
• Current use of any medication that could alter immune reactivity.
• Infection with HBV at the present time or in the past, confirmed by HBV markers test.
• Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.
• Pregnancy and breast-feeding.

Sponsors & Collaborators

• VBI Vaccines Inc.: lead

Study Sites (1)

Saint Petersburg State Budgetary Healthcare Institution

Saint Petersburg, Mirgorodskaya, 191167, Russia

Location

Related Publications (1)

• Esaulenko EV, Yakovlev AA, Volkov GA, Sukhoruk AA, Surkov KG, Kruglyakov PV, Diaz-Mitoma F. Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 Randomized Clinical Trial in the Russian Federation. Clin Infect Dis. 2021 Nov 2;73(9):e3333-e3339. doi: 10.1093/cid/ciaa1649.

  PMID: 33119068 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Pre-S vaccine; Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Final CSR does not follow ICH guidelines and the original document in Russian was translated into English for the purpose of writing the manuscript and completing the documentation in clinicaltrials.gov

Results Point of Contact

• Title: Dr Francisco Diaz-Mitoma
• Organization: VBI Vaccines Inc.

fdiazmitoma@vbivaccines.com

613-297-3304

Study Officials

• Elena Esaulenko

  Saint Petersburg State Paediatric Medical University

  PRINCIPAL INVESTIGATOR

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: December 9, 2019
• First Posted: December 24, 2019
• Study Start: April 18, 2014
• Primary Completion: April 20, 2015
• Study Completion: April 20, 2015
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-03

Locations

RU (1)