Status:
COMPLETED
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
Lead Sponsor:
Novosanis NV
Conditions:
Hepatitis B
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intr...
Eligibility Criteria
Inclusion
- healthy adults, checked anamnestically (based on medical history) at entry of the study
- 18-35 years
- vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask for a document of this proof at the service occupational medicine of the University of Antwerp.
- capable of understanding, reading and writing Dutch
Exclusion
- other vaccination(s) 4 weeks before study onset
- pregnancy and lactation (women will be questioned during anamnesis)
- plan to have other vaccination during the study period
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02186977
Start Date
March 1 2016
End Date
December 1 2016
Last Update
March 28 2017
Active Locations (1)
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1
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Wilrijk, Antwerp, Belgium, 2610