drugset / Trial / NCT02186977

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

NCT02186977

Phase 1 Completed 48 enrolled Novosanis NV
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2016-03
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HBVAXPRO Vaccine 0.1 ml Intravenous
Subject HBVAXPRO Vaccine 1 ml Intramuscular