Status:
COMPLETED
Hepatitis B Vaccine for Non-responders
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
CyTuVax
Conditions:
Hepatitis B
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but...
Detailed Description
Rationale: Worldwide, people are suffering from the consequences of Hepatitis B (HB) virus infection. Currently available vaccines are protective in most of the vaccinees, however, a small part of th...
Eligibility Criteria
Inclusion
- 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
- Willing to adhere to a highly effective birth control method during the duration of the study
- 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 1 to 3 months after the last vaccination that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: HBsAg antibody titer superior to 10mIU/ml. In case the subjects do not have a titer analysis performed 1 to 3 months after their last recorded vaccination, the potential subject can be included after permission from the project leader after analysis of the case file.
Exclusion
- 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 - excluding anti-histaminics -, 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 or daily use of corticosteroids, including chronic use of local corticosteroids)
- Any vaccination within 3 months before screening excluding flu vaccination
- 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. Participants on coumadins anticoagulants and participants receiving 2 platelet aggregation inhibitors can not be included in the study. People on the direct oral anticoagulant dabigatran, apixaban, edoxaban, and rivaroxaban and participants using only one platelet aggregation inhibitor can be included.
- Female subjects planning to become pregnant or breastfeeding babies until visit 4
- Females: positive 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 3 months Temporary exclusion criterion for vaccination
- Temperature \> 38.4°C will lead to postponement of participation and vaccination.
- Screening may continue when the temperature has normalized.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2019
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03415672
Start Date
October 11 2017
End Date
January 9 2019
Last Update
January 31 2019
Active Locations (3)
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1
Vaxinfectio - Antwerp University
Antwerp, Belgium
2
Ziekenhuis Oost-Limburg
Genk, Belgium
3
Maastricht UMC
Maastricht, Netherlands, 6202 AZ