NCT02186977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

July 8, 2014

Last Update Submit

March 27, 2017

Conditions

Hepatitis B

Keywords

immunogenicitysafetyproof of concept

Outcome Measures

Primary Outcomes (1)

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

    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

    during 14 days post vaccination

Study Arms (4)

Intramuscular group

ACTIVE COMPARATOR

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

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

Intradermal group (Mantoux)

EXPERIMENTAL

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

Intradermal group (VAX-ID) A

EXPERIMENTAL

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

Intradermal group (VAX-ID) B

EXPERIMENTAL

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.

Device: VAX-ID

Interventions

VAX-IDDEVICE

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

Also known as: INTRADERMAL
Intradermal group (VAX-ID) AIntradermal group (VAX-ID) B
1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)DRUG

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

Also known as: INTRAMUSCULAR
Intramuscular group
0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)DRUG

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

Also known as: MANTOUX_INTRADERMAL
Intradermal group (Mantoux)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults, checked anamnestically (based on medical history) at entry of the study
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

Wilrijk, Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Injections, IntradermalInjections, Intramuscular

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Injections, SubcutaneousInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Pierre Van Damme, Prof

    Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)