Last updated on November 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatitis B Vaccines
  • Age: Between 18 - 45 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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