Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: HBVaxPro; HBAI20
Intervention description: 3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.; 2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adjuvants, immunologic; Interleukin-2; Hepatitis B vaccines; Non-responders

Summary:

      The purpose of this study is to determine whether the HBAI20 vaccine is safe and more
      immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis
      B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not
      have a protective anti hepatitis B antibody titer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health as determined by the outcome of medical history, physical examination
             screening/baseline labs and clinical judgment of the clinical investigator

          -  Age 18 to 59 years, inclusive at the time of enrolment

          -  Willing and able to adhere to the study regimen

          -  Having a signed informed consent form

        Non-responders:

        - Documented non-responders: Subjects with documented two cycles of Hepatitis B vaccination
        (total of 6 vaccinations) and titer analysis that show that they have not developed the
        Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody
        titer higher to 10mIU/ml.

        Exclusion Criteria:

          -  Any infectious disease at the time of screening and/or enrolment

          -  Positive HIV, Hepatitis B virus or Hepatitis C virus serology

          -  Positive anti-IL-2 antibody titer

          -  Known or suspected immune deficiency

          -  Known or suspected disease that influences the immune system including chronic
             allergies that require frequent anti-allergy medication, cancer and transplantation
             recipients

          -  Known or suspected allergy to any of the vaccine components.

          -  Dialysis patient

          -  History of unusual or severe reactions to any previous vaccination

          -  History of any neurologic disorder, including epilepsy and autism

          -  Use of medication that influences the immune system (immune suppressive treatment)

          -  Any vaccination within 3 months before screening

          -  Blood donation within 1 month before screening

          -  Administration of plasma (incl. immunoglobulins) or blood products within 12 months
             before screening

          -  Participation in another clinical trial within 3 months before screening

          -  Abnormal pre-treatment laboratory parameters which are clinically relevant according
             to the investigator

          -  Bleeding disorders, or use of medication for bleeding disorders, and use of
             anti-coagulants

          -  Female subjects planning to become pregnant or breastfeeding babies until visit 7

          -  Females: positive urine pregnancy test. Urine test positive at screening date or
             positive urine pregnancy test on the day of vaccination

          -  Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one
             alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure
             (35ml) or one port/sherry (75ml)). Regular use of controlled drugs

        Exclusion criterion for Hepatitis B naïve subjects (groups 1 and 2):

        - Previous vaccination with Hepatitis B vaccine

        Exclusion criterion for non-responders (group 3):

        - Any Hepatitis B vaccination in the last 6 months

        Temporary exclusion criterion for vaccination

        - Ear temperature > 38.4°C will lead to postponement of participation and vaccination.
        Screening may continue when the temperature has normalized.