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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02186977

Acronym

POC_VAX-ID

Enrollment

Registered

2014-07-10

Start date

2016-03-31

Completion date

2016-12-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

immunogenicity, safety, proof of concept

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.

Interventions

DRUG1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)

1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)

DRUG0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)

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

DEVICEVAX-ID

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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	during 14 days post vaccination

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026