Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (POC_VAX-ID)
Hepatitis B
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring immunogenicity, safety, proof of concept
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Intramuscular group
Intradermal group (Mantoux)
Intradermal group (VAX-ID) A
Intradermal group (VAX-ID) B
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected.
These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.
These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected.