Hepatitis B VaccinesPhase 3NCT03408730
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
A Phase 3 study testing Hepatitis B Vaccination in people with Hepatitis B Vaccines, run by VBI Vaccines Inc. at 26 sites in 6 countries.
Trial summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults 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 Vaccines
- What is being tested?
- Hepatitis B Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,838 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 14 Dec 2017to 1 Oct 2019
- 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
- Any gender
- Age 18-45 years
- Healthy, as determined by a physical examination and values of laboratory tests
- If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method
- Able and willing to give informed consent
Who cannot join
- Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)
- Treatment by immunosuppressant within 30 days of enrollment
- 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 week prior to enrolment
Show all 22Show fewer
- 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
- Unwilling, or unable in the opinion of the investigator, to comply with study requirements
- Immediate family members of study center staff
- Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers
- 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 with Glomerular Filtration Rate (GFR) <90 mL/min/ 1.73 m2 at screening
- BMI ≥ 35
- Uncontrolled hypertension
- Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening
- Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States15 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Clinical Research Altanta
Atlanta, Georgia, 30281
Accel Research Sites
Birmingham, Alabama, 35216
Advanced Clinical Research (ACR)
Boise, Idaho, 83642
Rapid Medical Research
Cleveland, Ohio, 44122
Aventiv Research Inc
Columbus, Ohio, 43213
Avail Clinical Research
DeLand, Florida, 32720
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Ruane Clinical Research Group Inc
Los Angeles, California, 90036
Suncoast Research Group
Miami, Florida, 33135
Montana Medical Research, LLC
Missoula, Montana, 59808
CareOne Research
North Hollywood, California, 91606
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Advanced Clinical Research (ACR)
Salt Lake City, Utah, 84088
Clinical Research Consortium Arizona, LLC
Tempe, Arizona, 85283
Canada4 sites
Medicore Research Inc
Greater Sudbury, Ontario
Manna Montreal
Montreal, Quebec
Manna Research Quebec
Québec, Quebec
Manna Toronto
Toronto, Ontario
United Kingdom4 sites
Bristol Royal Hospital for Children
Bristol
St. George's University Hospital NHS Foundation Trust
London
Oxford University
Oxford, Oxfordshire
Southampton General Hospital
Southampton
About this study
Official title: A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Read the detailed description
The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and 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.
- Conditions
- Hepatitis B Vaccines
- Being tested
- Hepatitis B Vaccination
- Keywords
- Hepatitis B Vaccines
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B VaccinationBiological
Hepatitis B Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Sci-B-Vac Lot A Hep B Vaccination | Experimental | Sci-B-Vac Lot A Hepatitis B Vaccination Receives: Biological: Hepatitis B Vaccination |
| Sci-B-Vac Lot B Hep B Vaccination | Experimental | Sci-B-Vac Lot B Hepatitis B Vaccination Receives: Biological: Hepatitis B Vaccination |
| Sci-B-Vac Lot C Hep B Vaccination | Experimental | Sci-B-Vac Lot C Hepatitis B Vaccination Receives: Biological: Hepatitis B Vaccination |
| Comparator: ENGERIX-B Hep B Vaccination | Active comparator | Active Comparator: ENGERIX-B Hepatitis B Vaccination Receives: Biological: Hepatitis B Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of [0.67, 1.5].
Measured: 4 weeks after third vaccination (Study Day 196)
Secondary outcomes (2)
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
The difference in proportions [SPR(Sci-B-Vac®)-SPR(Engerix-B®)] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was > 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B®
Measured: 4 weeks after third vaccination (Study Day 196)
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
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.
Measured: Day of vaccine administration and six subsequent days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start14 Dec 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
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 B VaccinesStudies 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
- Model description
- Double-blind Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,838 participants (actual)
Sponsor and investigators
- Lead sponsor
- VBI Vaccines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Diaz-Mitoma, MD, PhD, Study director, VBI Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408730
- Sponsor's protocol ID
- Sci-B-Vac-002
- Other IDs
- 2017-001820-22, 2017
- Status last verified
- Mar 2021
- First submitted
- 23 Nov 2017
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vesikari T, Finn A, van Damme P, Leroux-Roels I, Leroux-Roels G, Segall N, Toma A, Vallieres G, Aronson R, Reich D, Arora S, Ruane PJ, Cone CL, Manns M, Cosgrove C, Faust SN, Ramasamy MN, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson D, Popovic V, Diaz-Mitoma F; CONSTANT Study Group. Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128652. doi: 10.1001/jamanetworkopen.2021.28652.
PubMed 34636914
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
- ClinicalTrials.gov ID
- NCT03408730
- Acronym / sponsor ID
- Sci-B-Vac-002
- Conditions
- Hepatitis B Vaccines
- Keywords
- Hepatitis B Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,838 participants (actual)
- Lead sponsor
- VBI Vaccines Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Detailed description
The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Sci-B-Vac Lot A Hep B Vaccination | Experimental | Biological: Hepatitis B VaccinationSci-B-Vac Lot A Hepatitis B Vaccination |
| Sci-B-Vac Lot B Hep B Vaccination | Experimental | Biological: Hepatitis B VaccinationSci-B-Vac Lot B Hepatitis B Vaccination |
| Sci-B-Vac Lot C Hep B Vaccination | Experimental | Biological: Hepatitis B VaccinationSci-B-Vac Lot C Hepatitis B Vaccination |
| Comparator: ENGERIX-B Hep B Vaccination | Active comparator | Biological: Hepatitis B VaccinationActive Comparator: ENGERIX-B Hepatitis B Vaccination |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Any gender
- Age 18-45 years
- Healthy, as determined by a physical examination and values of laboratory tests
- If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method
- Able and willing to give informed consent
Key exclusion criteria (22 listed)
- Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental)
- Treatment by immunosuppressant within 30 days of enrollment
- History of immunological function impairment
- Pregnancy or breastfeeding
- Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment
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 |
|---|---|---|
| Hepatitis B VaccinationHepatitis B Vaccination | Biological | Comparator: ENGERIX-B Hep B Vaccination, Sci-B-Vac Lot A Hep B Vaccination, Sci-B-Vac Lot B Hep B Vaccination, Sci-B-Vac Lot C Hep B Vaccination |
Primary outcome
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
Time frame: 4 weeks after third vaccination (Study Day 196)
To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of [0.67, 1.5].
2 secondary outcomes
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
Time frame: 4 weeks after third vaccination (Study Day 196)
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Time frame: Day of vaccine administration and six subsequent days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34636914Vesikari T, Finn A, van Damme P, Leroux-Roels I, Leroux-Roels G, Segall N, Toma A, Vallieres G, Aronson R, Reich D, Arora S, Ruane PJ, Cone CL, Manns M, Cosgrove C, Faust SN, Ramasamy MN, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson D, Popovic V, Diaz-Mitoma F; CONSTANT Study Group. Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128652. doi: 10.1001/jamanetworkopen.2021.28652.
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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.
Francisco Diaz-Mitoma, MD, PhD study director
VBI Vaccines
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hepatitis B Vaccination in people with Hepatitis B Vaccines, run by VBI Vaccines Inc. at 26 sites in 6 countries.
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 5 inclusion and 22 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, United Kingdom, Belgium, Finland and 1 more country. 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 14 Oct 2020). 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?
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1) (time frame: 4 weeks after third vaccination (Study Day 196)). 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 NCT03408730, 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 Mar 2021.