Hepatitis B vaccine for non-responders
Conditions
Interventions
Study subjects will be vaccinated 3 times at 0, 1 and 6 months from the
beginning of the study.
Immunologic
Interleukin-2
Sponsors
Cytuvax BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Naive subjects must meet all of the following 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 superior to 10mIU/ml.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Any infectious disease at the time of screening and/or enrolment - Positive HIV, Hepatitis B virus or Hepatitis C virus serology - 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: see IB, IMPD - 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 and during the trial (until last visit) - Administration of plasma (incl. immunoglobulins) or blood products within 3 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 negative at screening date and negative 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 criteria for vaccination - Ear temperature > 38.4°C will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the number and intensity of local and systemic adverse reactions (redness, swelling, impaired movement). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameter is the HBAI20 vaccine immunogenicity as measured by the median titer, GMT, GMT increase, proportion of subjects with a virus specific antibody titer measure by the COBAS system of * 10 mIU/ml, seroconversion rate, and cellular immunogenicity. Seroconversion is defined as a four-fold increase in titer or a conversion from seronegative to a virus antibody titer of 10 mIU/ml after two vaccinations. | — |
Countries
The Netherlands
Outcome results
None listed