Trial record 1 of 1 for:
CONSTANT, Sci-B-Vac
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03408730 |
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Recruitment Status :
Completed
First Posted : January 24, 2018
Results First Posted : October 14, 2020
Last Update Posted : March 25, 2021
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Sponsor:
VBI Vaccines Inc.
Information provided by (Responsible Party):
VBI Vaccines Inc.
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Brief Summary:
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B Vaccines | Biological: Hepatitis B Vaccination | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2838 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double-blind Randomized Controlled Trial |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT) |
| Actual Study Start Date : | December 14, 2017 |
| Actual Primary Completion Date : | October 1, 2019 |
| Actual Study Completion Date : | October 1, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot A Hepatitis B Vaccination
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Biological: Hepatitis B Vaccination
Hepatitis B Vaccination |
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Experimental: Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
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Biological: Hepatitis B Vaccination
Hepatitis B Vaccination |
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Experimental: Sci-B-Vac Lot C Hep B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
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Biological: Hepatitis B Vaccination
Hepatitis B Vaccination |
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Active Comparator: Comparator: ENGERIX-B Hep B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
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Biological: Hepatitis B Vaccination
Hepatitis B Vaccination |
Primary Outcome Measures :
- 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].
Secondary Outcome Measures :
- 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) ]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®
- Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Day of vaccine administration and six subsequent days ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408730
Locations
Show 26 study locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
| Study Director: | Francisco Diaz-Mitoma, MD, PhD | VBI Vaccines |
Study Documents (Full-Text)
Documents provided by VBI Vaccines Inc.:
Documents provided by VBI Vaccines Inc.:
Statistical Analysis Plan [PDF] December 4, 2019
Study Protocol [PDF] May 9, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VBI Vaccines Inc. |
| ClinicalTrials.gov Identifier: | NCT03408730 |
| Other Study ID Numbers: |
Sci-B-Vac-002 2017-001820-22 ( EudraCT Number ) |
| First Posted: | January 24, 2018 Key Record Dates |
| Results First Posted: | October 14, 2020 |
| Last Update Posted: | March 25, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by VBI Vaccines Inc.:
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Hepatitis B Vaccines |
Additional relevant MeSH terms:
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Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |