A phase 2 clinical study into the immune responde and adverse effects of a Hepatitis B vaccine in subjects that do not respond (non-responders) to the Hepatitis B vaccine.

Phase 1

• Conditions: In a minority of the population (5-10%) standard vaccines against Hepatitis-B do not induce protective immunity, even after prolonged and repeated vaccination courses. Non- responsiveness to hepatitis-B vaccination poses a severe problem for people with high risk of infection (e.g. medical and laboratory staff, surgeons). Several approaches have been proposed to overcome non- responsiveness, however these work only to a minimal extent leaving too many people unprotected.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002720-91-NL
• Lead Sponsor: CyTuVax BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

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 more 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified