Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novosanis NV

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