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Lot-to-lot Consistency of Sci-B-Vac™ in Adults

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ClinicalTrials.gov Identifier: NCT03408730
Recruitment Status : Completed
First Posted : January 24, 2018
Results First Posted : October 14, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

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

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.

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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
Experimental: Sci-B-Vac Lot A Hep B Vaccination
Sci-B-Vac Lot A Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination

Experimental: Sci-B-Vac Lot B Hep B Vaccination
Sci-B-Vac Lot B Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination

Experimental: Sci-B-Vac Lot C Hep B Vaccination
Sci-B-Vac Lot C Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination

Active Comparator: Comparator: ENGERIX-B Hep B Vaccination
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Biological: Hepatitis B Vaccination
Hepatitis B Vaccination




Primary Outcome Measures :
  1. 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 :
  1. 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®

  2. 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 Show 26 study locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
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Study Director: Francisco Diaz-Mitoma, MD, PhD VBI Vaccines
  Study Documents (Full-Text)

Documents provided by VBI Vaccines Inc.:
Statistical Analysis Plan  [PDF] December 4, 2019
Study Protocol  [PDF] May 9, 2018

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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: November 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VBI Vaccines Inc.:
Hepatitis B Vaccines
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs