Trials / Completed
CompletedNCT02186977
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Novosanis NV · Industry
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VAX-ID | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
| DRUG | 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) | 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) |
| DRUG | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2014-07-10
- Last updated
- 2017-03-28
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02186977. Inclusion in this directory is not an endorsement.