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

Hepatitis B Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186977
• Other study ID #: CP140465_2014_001_v5
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2014
• Last updated: March 27, 2017
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Novosanis NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

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)
• 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection

Locations

Country	Name	City	State
Belgium	Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Novosanis NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anamnestic response after intradermal or intramuscular hepatitis B booster vaccination in previously fully immunized subjects		after 14 days
Secondary	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		during 14 days post vaccination