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

Novosanis

Status and phase: Completed; Phase 1

Conditions: Hepatitis B

Treatments: Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD); Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD); Device: VAX-ID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186977

CP140465_2014_001_v5

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Intramuscular group

Active Comparator group

Description:

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

Treatment:

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

Intradermal group (Mantoux)

Experimental group

Description:

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.

Treatment:

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

Intradermal group (VAX-ID) A

Experimental group

Description:

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.

Treatment:

Device: VAX-ID

Intradermal group (VAX-ID) B

Experimental group

Description:

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.

Treatment:

Device: VAX-ID