Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Condition: Healthy Volunteers
MeSH terms: Hepatitis B; Hepatitis
Intervention: hepatitis B vaccine; hepatitis B vaccine
Intervention description: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL; Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hepatitis B Virus Antibody Booster Program
    

Eligibility criteria:

        Inclusion Criteria

          -  Age 20-55 years.

          -  Naïve or previously hepatitis B-vaccinated males or females.

          -  Normal and healthy as determined by medical history, physical exam, vital signs and
             clinical laboratory tests

          -  Subject must meet all required/recommended subject suitability criteria that pertain
             to normal source plasma donors with the following exception:

          -  Subjects who previously tested positive for HBsAg may be accepted into the anti- HBs
             program provided they now test negative and meet all other normal donor suitability
             criteria.

          -  Written informed consent.

        Exclusion Criteria:

          -  Subjects who have received a hepatitis B vaccination in the previous six months.

          -  History of hypersensitivity to yeast or any components of the Engerix-B® vaccine

          -  History of hypersensitivity to any hepatitis B-containing vaccine.

          -  Use of any investigational product within the past 30 days or during the course of the
             study.

          -  Use of steroids or immunosuppressives during the study period.

          -  Received immunosuppressive therapy (including systemic steroids) within 30 days before
             study entry

          -  Subjects who have received cytotoxic therapy (in the previous 5 years prior to study
             entry)

          -  Received parenteral immune globulin products or blood products within 3 months before
             study entry with the following exceptions:

          -  RhoGAM (or equivalent anti-D immune globulin) within 6 weeks before study entry;

          -  Pertussis immune globulin: no exclusion

          -  Received parenteral immune globulin products or blood products (within 3 months before
             study entry)

          -  Past, present, or suspected IV drug use

          -  Positive HIV, HBV* or HCV test result (*except as described above in Inclusion
             Criteria)

          -  Autoimmune disease (such as, but not limited to demyelinating disease)

          -  Subjects with cancer, heart disease (including hospitalization for myocardial
             infarction, arrhythmia, syncope, congestive heart failure), uncontrolled hypertension,
             uncontrolled insulin-dependent diabetes mellitus, seizures, kidney disease

          -  Severely or morbidly obese, or higher obesity classification, which corresponds to BMI
             of 35 or higher

          -  Pregnancy or lactation.