Hepatitis BPhase 3NCT04209400

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

A Phase 3 study testing Sci-B-Vac® and Engerix-B® in people with Hepatitis B, run by VBI Vaccines Inc. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: Sci-B-Vac® and Engerix-B®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteRussia
Study dates: 18 Apr 2014to 20 Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Saint Petersburg State Budgetary Healthcare Institution
Saint Petersburg, Mirgorodskaya, 191167

Other trials in Russia

About this study

Official title: A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects

Read the detailed description

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 hepatitis B-naive healthy adult subjects (n = 100). The study was conducted at 3 study sites in the Russian Federation. Subjects who passed the screening successfully were randomized into two groups, Sci-B-Vac® (10 μg dose) and Engerix-B® (20 μg dose), in a 1:1 ratio. Subjects were vaccinated three times at days 1, 28, and 180 of the study.

Statistical Methods: Evaluation and comparison of immunogenicity were conducted at baseline, day 28, day 90 (60 days after the second vaccination), day 180 (prior to administering the third vaccine, 90 days after the second vaccination), and day 210 (30 days after the third vaccination) of the study.

The primary outcome was the seroconversion rate (proportion of subjects with anti-HBs levels ≥ 2.1 mIU/mL) after the third vaccination at day 210. The non-inferiority margin was set at 4%. The percentage of subjects who achieved seroconversion was analyzed using the Chi-square test for proportions along with the McNemar's test for repeated measurements in each group. The non-inferiority hypotheses were confirmed if the lower range of the confidence interval was at least -4%. The secondary endpoint was SPR (≥10 mIU/ml), measured at days 1, 28, 90, 180 and 210.

Demographic data, initial parameters, safety parameters, tolerance of the experimental vaccine, and other study parameters were analyzed using descriptive statistics (mean value, standard deviation, median, minimum and maximum values, range, quartiles, the number of valid cases-for quantitative variables; absolute number, proportion, allocation-for qualitative variables). A comparative assessment of the detection rate for different parameters in the two comparison groups was conducted using the Student's t-test; differences were considered statistically significant at a significance level of 5%. The assay used to measure anti-HBs concentrations had an upper limit of 1000 mIU/mL.

Conditions: Hepatitis B
Being tested: Sci-B-Vac®, Engerix-B®
Keywords: Sci-B-Vac®, Prophylactic vaccine, HepB vaccines, Phase 3, pre-S1, pre-S2, Surface antigen
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sci-B-Vac®Biological
Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
Engerix-B®Biological
Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml

Study groups in NCT04209400
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Engerix-B®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 210

Secondary outcomes (3)

Seroprotection Rate
Percentage of subjects with an anti-HBs antibody level ≥ 10 mIU/mL prior to vaccination, 28 days after the first vaccination, 60 and 150 days after the second vaccination and 30 days after the third vaccination. The development of an anti-HBs antibody level of at least 10 mIU/mL is an established surrogate of seroprotection and correlate of protective immunity against HBV.
Measured: Days 1, 28, 90, 180, 210
Seroconversion Rate
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL prior to vaccination, 28 days after the first vaccination and 60 and 150 days after the second vaccination. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
Measured: Days 1, 28, 90, 180
Geometric Mean Concentrations (GMC) of HBs Antibodies
Geometric mean concentration of anti-HBs antibody in mIU/mL 28 days after the first vaccination, 60 and 150 days after the second vaccination, and 30 days after the third vaccination.
Measured: Days 1, 28, 90, 180, and 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201420 Apr 2015

First posted24 Dec 2019
Study start18 Apr 2014
Primary completion20 Apr 2015
Study completion20 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis BStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04209400
Sponsor's protocol ID: 38-13-040 RUS
Status last verified: Mar 2022
First submitted: 9 Dec 2019
Last updated: 25 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33119068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects
ClinicalTrials.gov ID: NCT04209400
Acronym / sponsor ID: 38-13-040 RUS
Conditions: Hepatitis B
Keywords: Sci-B-Vac®, Prophylactic vaccine, HepB vaccines, Phase 3, pre-S1, pre-S2, Surface antigen
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: VBI Vaccines Inc.Industry (pharma, biotech, devices)
Study start: 18 Apr 2014 (actual)
Primary completion: 20 Apr 2015 (actual)
Study completion: 20 Apr 2015 (actual)
First posted: 24 Dec 2019 (actual)
Results: Posted 25 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sci-B-Vac®	Experimental	Biological: Sci-B-Vac®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.
Engerix-B®	Active comparator	Biological: Engerix-B®The single-antigen HepB vaccine, Engerix-B® (GSK), contains the small S recombinant protein. Engerix-B® was supplied in 1.0 ml vials.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sci-B-Vac®Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml	Biological	Sci-B-Vac®
Engerix-B®Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml	Biological	Engerix-B®

Primary outcome

Seroconversion Rate
Time frame: Day 210
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.

3 secondary outcomes

Seroprotection Rate
Time frame: Days 1, 28, 90, 180, 210
Seroconversion Rate
Time frame: Days 1, 28, 90, 180
Geometric Mean Concentrations (GMC) of HBs Antibodies
Time frame: Days 1, 28, 90, 180, and 210

Results and safety

Results posted to the registry on 25 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sci-B-Vac®	50	50
Engerix-B®	50	49

Primary outcome: Seroconversion Rate

Time frame: Day 210. Count of participants. Unit: Participants

Measure	Sci-B-Vac® n = 47	Engerix-B® n = 47
Value	47	46

Sci-B-Vac® vs Engerix-B®: p = 1, Chi-squared

Population analysed: The primary analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, approximately 7 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sci-B-Vac®	0 of 50 (0%)	2 of 50 (4%)	0 of 50
Engerix-B®	0 of 49 (0%)	7 of 49 (14.3%)	0 of 49

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33119068Esaulenko 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.

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
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Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Enrolling by invitationPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elena Esaulenko principal investigator

Saint Petersburg State Paediatric Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sci-B-Vac® and Engerix-B® in people with Hepatitis B, run by VBI Vaccines Inc. at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion Rate (time frame: Day 210). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.