Trial | NCT02186977  Report issue

Title

Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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 Started
Mar 31
2016
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Mar 28
2017

Device VAX-ID

0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection

  • Other names: INTRADERMAL

Drug 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)

1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)

  • Other names: INTRAMUSCULAR

Drug 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)

0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection

  • Other names: MANTOUX_INTRADERMAL

Intramuscular group Active Comparator

These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.

Intradermal group (Mantoux) Experimental

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.

Intradermal group (VAX-ID) A Experimental

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.

Intradermal group (VAX-ID) B Experimental

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.

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
No Results Posted