Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
NCT ID: NCT02186977
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2016-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intramuscular group
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
Intradermal group (Mantoux)
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.
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Intradermal group (VAX-ID) A
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.
VAX-ID
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Intradermal group (VAX-ID) B
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.
VAX-ID
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Interventions
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VAX-ID
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy and lactation (women will be questioned during anamnesis)
* plan to have other vaccination during the study period
18 Years
35 Years
ALL
Yes
Sponsors
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Novosanis NV
INDUSTRY
Responsible Party
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Principal Investigators
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Pierre Van Damme, Prof
Role: PRINCIPAL_INVESTIGATOR
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Locations
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Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Wilrijk, Antwerp, Belgium
Countries
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Other Identifiers
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CP140465_2014_001_v5
Identifier Type: -
Identifier Source: org_study_id
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