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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Wilrijk, Antwerp, Belgium
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
Time frame: after 14 days
Safety: solicited local and systemic reactions, unsolicited adverse events and Serious Adverse Events occurrence, intensity and relationship to vaccination of all Adverse Events reported during the 14-day follow-up period after the challenge dose
Time frame: during 14 days post vaccination
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