A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™
Condition: Hepatitis B
MeSH terms: Hepatitis B
Intervention: Sci-B-Vac™
Intervention description: Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices (GMP). It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: This study was an open-label, single arm study. No control groups were deemed necessary since this was a phase IV trial for which the goal, set according to the European Pharmacopeia 1056, was to achieve 95% SPR after the third vaccination.
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: SciB018; Prophylactic vaccine; Sci-B-Vac™; HepB vaccines; Phase 4; pre-S1; pre-S2; Surface antigen

Summary:

      Each Sci-B-Vac™ lot to be released to the market is tested in comparison to a reference
      batch,which has to be tested in a human clinical trial. This study was conducted by SciVac
      Ltd. to to evaluate the immunogenicity and explore the immune kinetics of Sci-B-Vac™ in
      support of its qualification as new reference standard which according to the European
      Pharmacopeia (Ph.Eur. 1056) should elicit ≥ 95% seroprotection rate (SPR) of Hepatitis B
      surface (HBs) antibody concentrations ≥ 10 milli-International Units (mIU) per ml in young,
      healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males and females 20 - 40 years of age.

          2. Subjects who provided written informed consent to participate in the study.

          3. Subjects in general good health in the opinion of the investigator as determined by
             medical history, vital signs and a physical examination.

          4. No clinically-significant abnormalities in hematology, blood chemistry, or urinalysis
             lab tests at Screening.

          5. Women of child-bearing potential had to practice an acceptable method of birth control
             or practice abstinence during the study period or be surgically sterilized, from
             Screening visit throughout the vaccination phase and for 28 days after the last
             injection and agree to undergo repeated pregnancy tests.

          6. Subjects had to be able to understand the requirements of the study and willing to
             comply with the requirements of the study.

        Exclusion Criteria:

          1. Known history of significant medical disorder, which in the investigator's judgment
             contraindicates administration of the vaccine or may interfere with the subject's
             compliance or the interpretation of study assessment parameters.

          2. Any clinically-significant abnormality upon physical examination or in the clinical
             laboratory tests at Screening visit.

          3. Treatment with immune suppressive agents.

          4. Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          5. History of Hepatitis B virus (HBV) infection or confirmed exposure to HBV

          6. Previous vaccination against Hepatitis B.

          7. Positive for HBsAg, anti-HBs antibodies, anti-HBc antibodies, anti-HCV (hepatitis C
             virus) antibodies or anti- HIV antibodies.

          8. Drug abuse

          9. Known hypersensitivity or allergy to any component of the study vaccine.

         10. Body mass index (BMI) < 18.5 or ≥ 30 kg/m2.

         11. Known concomitant disease or any other medical condition that is considered by the
             investigator likely to interfere with the subject's compliance or the interpretation
             of study assessments.

         12. Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug
             administration that is considered of significance by the Principal Investigator.

         13. Female subjects: pregnant, lactating or planning a pregnancy.

         14. Any confirmed or suspected immunosuppressive or immunodeficient condition.

         15. Receipt of blood or immunoglobulin transfusion six months prior to the first vaccine
             dose and during the course of the trial.

         16. Unwilling or unable (in the judgment of the investigator) to comply with all the
             requirements of the protocol.

         17. Participate in another clinical trial within 3 months prior to first vaccination
             (calculated from the previous study's last dosing date).