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

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ClinicalTrials.gov Identifier: NCT03408730
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : November 21, 2018
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2837 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
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : October 22, 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. To demonstrate the manufacturing equivalence, in terms of immunogenicity, of three independent consecutive lots of the Sci-B-Vac 4 weeks after the third vaccination [ Time Frame: 4 weeks after third vaccination (Study Day 196) ]
    The upper and lower bound of the two sided 95% confidence interval (CI) of the geometric mean concentration (GMC) of anti-HBs ratios 4 weeks after the third injection, for all three pairwise comparisons (GMC of anti-HBs in group A/B, GMC of anti-HBs in group A/C, GMC of anti-HBs in group B/C), are within [0.67, 1.5]


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 4 weeks after 3rd vaccination (Study Day 196) ]
    Non-inferiority of a 3-dose campaign of SCI-B-VAC or Engerix-B

  2. Solicited Adverse Events following Vaccination [ Time Frame: Up to 6 days following Injection ]
    Number (%) and Grade (1-4) of subject-reported solicited (on the day of vaccination and during the next 6 days) after each vaccination

  3. Unsolicited Adverse Events following Vaccination [ Time Frame: Up to 27 Days following Vaccination ]
    Number (%) and Grade (1-4) of unsolicited adverse events (AE) (on the day of vaccination and during the next 27 days) after each vaccination

  4. Serious Adverse Events following Vaccination [ Time Frame: Up to approximately 1 year (Up to Study Day 336) ]
    Number (%) of Serious Adverse Events (SAEs), medically significant event or new onset of chronic illness (through Day 336, approximately 1 year)

  5. Abnormal Vital Signs or Physical Examination findings following Vaccination [ Time Frame: Up to approximately 1 year (Up to Study Day 336) ]
    Number (%) of subjects with abnormal vital signs; physical examination findings by type of abnormality, compared to baseline (through Study Day 336, approximately 1 year)

  6. Abnormal Clinical Laboratory Parameters following Vaccination [ Time Frame: Up to one week following vaccination (Study Days 7, 35, and 175) ]
    Number (%) of subjects with abnormal clinical laboratory parameters from baseline assessments by type, one week after each vaccination (Study Days 7, 35 and 175) with either Sci-B-Vac or ENGERIX-B (clinical laboratory sub-study).



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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


  Show 25 Study Locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
Study Director: Francisco Diaz-Mitoma, MD, PhD VBI Vaccines

Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT03408730     History of Changes
Other Study ID Numbers: Sci-B-Vac-002
2017-001820-22 ( EudraCT Number )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs