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

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Device: VAX-ID; Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD); Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)

• Registration Number: NCT02186977
• Lead Sponsor: Novosanis NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Study Start: 2016-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradermal group (VAX-ID) A	VAX-ID	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.
Intramuscular group	1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)	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)	0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)	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) B	VAX-ID	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.

Primary Outcome Measures

Name	Time	Method
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects	after 14 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute; 🇧🇪 Wilrijk, Antwerp, Belgium