Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders
- Conditions
- non-responsiveness to hepatitis B10047438
- Registration Number
- NL-OMON47410
- Lead Sponsor
- CyTuVax BV
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 59
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the efficacy of the HBAI20 vaccination for<br /><br>non-responders. To this end, the immunogenicity of the HBAI20 vaccine will be<br /><br>measured by median antibody titre, GMT, GMT gain and seroprotection.<br /><br>Seroprotection is defined as a fourfold increase in titer or a conversion of<br /><br>seronegative to a virus antibody titre of * 10 mlU/ml.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameter is the safety of the HBAI20 vaccine, in which the<br /><br>number and intensity of local and systemic side effects is investigated.</p><br>