Status:
COMPLETED
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Lead Sponsor:
VBI Vaccines Inc.
Conditions:
Hepatitis B Vaccines
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
2838 Patients enrolled
Trial Details
Trial ID
NCT03408730
Start Date
December 14 2017
End Date
October 1 2019
Last Update
March 25 2021
Active Locations (26)
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1
Accel Research Sites
Birmingham, Alabama, United States, 35216
2
Clinical Research Consortium Arizona, LLC
Tempe, Arizona, United States, 85283
3
Anaheim Clinical Trials
Anaheim, California, United States, 92801
4
Ruane Clinical Research Group Inc
Los Angeles, California, United States, 90036