drugset / Trial / NCT02186977
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HBVAXPRO | Vaccine | 0.1 ml | Intravenous |
| Subject | HBVAXPRO | Vaccine | 1 ml | Intramuscular |