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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
VAX-ID
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Sponsored by
Novosanis NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring immunogenicity, safety, proof of concept

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Intramuscular group

Intradermal group (Mantoux)

Intradermal group (VAX-ID) A

Intradermal group (VAX-ID) B

Arm Description

These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.

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.

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.

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.

Outcomes

Primary Outcome Measures

Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2014
Last Updated
March 27, 2017
Sponsor
Novosanis NV
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1. Study Identification

Unique Protocol Identification Number
NCT02186977
Brief Title
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
Acronym
POC_VAX-ID
Official Title
Proof Of Concept Study: Immunogenicity and Safety of Hepatitis B Injection in the Dermis in Healthy Volunteers Using an Intradermal Injection Device (VAX-ID)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novosanis NV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
immunogenicity, safety, proof of concept

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intramuscular group
Arm Type
Active Comparator
Arm Description
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
Arm Title
Intradermal group (Mantoux)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intradermal group (VAX-ID) A
Arm Type
Experimental
Arm Description
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.
Arm Title
Intradermal group (VAX-ID) B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VAX-ID
Other Intervention Name(s)
INTRADERMAL
Intervention Description
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Intervention Type
Drug
Intervention Name(s)
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
Other Intervention Name(s)
INTRAMUSCULAR
Intervention Description
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
Intervention Type
Drug
Intervention Name(s)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Other Intervention Name(s)
MANTOUX_INTRADERMAL
Intervention Description
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Primary Outcome Measure Information:
Title
Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects
Time Frame
after 14 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Van Damme, Prof
Organizational Affiliation
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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