Trial record 10 of 435 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Novosanis NV
Sponsor:
Information provided by (Responsible Party):
Novosanis NV
ClinicalTrials.gov Identifier:
NCT02186977
First received: July 8, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

A proof of concept (POC) study will be conducted in 33 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.


Condition Intervention Phase
Hepatitis B
Device: VAX-ID
Drug: HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Novosanis NV:

Primary Outcome Measures:
  • Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects [ Time Frame: after 14 days ] [ Designated as safety issue: No ]

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 [ Time Frame: during 14 days post vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: January 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intramuscular group
These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region.
Drug: HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Active Comparator: 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: HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Experimental: Intradermal group (VAX-ID)
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)
Drug: HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186977

Contacts
Contact: Pierre Van Damme, Prof. pierre.vandamme@uantwerpen.be

Locations
Belgium
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute Not yet recruiting
Wilrijk, Antwerp, Belgium, 2610
Contact: Pierre Van Damme, Prof       pierre.vandamme@uantwerpen.be   
Principal Investigator: Pierre Van Damme, Prof         
Sponsors and Collaborators
Novosanis NV
Investigators
Principal Investigator: Pierre Van Damme, Prof Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute
  More Information

No publications provided

Responsible Party: Novosanis NV
ClinicalTrials.gov Identifier: NCT02186977     History of Changes
Other Study ID Numbers: CP140465_2014_001_v2
Study First Received: July 8, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Novosanis NV:
immunogenicity
safety
proof of concept

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014