non-responsiveness to hepatitis B
Conditions
Interventions
The subjects are vaccinated three times, in M0, M1 and M2.
adjuvant
Sponsors
CyTuVax BV
Eligibility
Age
18 Years to 64 Years
Inclusion 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 enrollment Willing and able to adhere to the study regimen Having a signed informed consent form Documented non-responders: Subjects with documented one or two cycles of Hepatitis B vaccination (total of 3 or more 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: Any infectious disease at the time of screening and/or enrollment 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 or daily use of corticosteroids) 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 4 Females: positive urine pregnancy test at screening date 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 Any Hepatitis B vaccination in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the efficacy of the HBAI20 vaccination for non-responders. To this end, the immunogenicity of the HBAI20 vaccine will be measured by median antibody titre, GMT, GMT gain and seroprotection. Seroprotection is defined as a fourfold increase in titer or a conversion of seronegative to a virus antibody titre of * 10 mlU/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameter is the safety of the HBAI20 vaccine, in which the number and intensity of local and systemic side effects is investigated. | — |
Countries
Belgium
Outcome results
None listed