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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intramuscular group<br>These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. | Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)<br>* 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)<br>* Other names: INTRAMUSCULAR;|
| Experimental: Intradermal group (Mantoux)<br>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. | Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)<br>* 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection<br>* Other names: MANTOUX_INTRADERMAL;|
| Experimental: Intradermal group (VAX-ID) A<br>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. | Device: VAX-ID<br>* 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection<br>* Other names: INTRADERMAL;|
| Experimental: Intradermal group (VAX-ID) B<br>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. | Device: VAX-ID<br>* 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection<br>* Other names: INTRADERMAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects |  | after 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | during 14 days post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunogenicity, safety, proof of concept