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NCT Number: NCT02186977

Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using 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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

Wilrijk, Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VAX-ID

Device

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

Other names: INTRADERMAL

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

Drug

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

Other names: INTRAMUSCULAR

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

Drug

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

Other names: MANTOUX_INTRADERMAL

Primary outcomes

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

    Time frame: after 14 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novosanis NV

Industry

Registry information

Official study 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)

Acronym: POC_VAX-ID

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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