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

March 27, 2017 updated by: Novosanis NV

Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intramuscular group
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
Drug: 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
Other Names:
  • INTRAMUSCULAR
Experimental: Intradermal group (Mantoux)
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.
Drug: 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Other Names:
  • MANTOUX_INTRADERMAL
Experimental: Intradermal group (VAX-ID) A
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.
Device: VAX-ID
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Other Names:
  • INTRADERMAL
Experimental: Intradermal group (VAX-ID) B
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.
Device: VAX-ID
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Other Names:
  • INTRADERMAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
Time Frame: after 14 days
after 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: during 14 days post vaccination
during 14 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosanis NV

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP140465_2014_001_v5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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