MedTrace Logo

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

NCT02186977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-03-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novosanis NV

    lead INDUSTRY

Principal Investigators

  • Pierre Van Damme, Prof · Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186977 on ClinicalTrials.gov