NCT01451801

Brief Summary

Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. These individuals are defined as non-responders. The investigators wish to investigate if mounting another kind of immune response, called the cellular immune (CMI) response, protects these non-responders. Aim/Hypothesis Primary aims:

  1. 1.To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
  2. 2.To establish the prevalence of serological non-responders after a standard course of HBV vaccination.
  3. 3.To assess the safety of the vaccine.
  4. 4.Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization
  5. 5.To compare the immunological profile before and after a standard HBV vaccination regimen on non-responders and responders
  6. 6.Establish a rapid test for measuring CMI after being HBV vaccinated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

October 10, 2011

Last Update Submit

October 25, 2012

Conditions

Hepatitis B

Keywords

Hepatitis Bnon responderscellular immune responsecytokinespredictorsHBsAg

Outcome Measures

Primary Outcomes (1)

  • Estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization

    Preparation of peripheral blood mononuclear cells (PBMC) Optimisation of antigen-specific cytokine flow cytometry Quantification of IFN-γ producing CD4+ T cells

    within 9. month from 1. vaccination

Secondary Outcomes (5)

  • Establish the prevalence of serological non-responders after a standard course of HBV vaccination defined by anti-HBs <10 mIU / ml

    Within 9 month from 1. vaccination

  • Assess the safety of the vaccine by evaluating the numbers and intensity of adverse and Serious adverse events

    Within 9 month from 1. vaccination

  • Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization

    within 9 month from 1. vaccination

  • Compare the immunological profile before and after a standard HBV vaccination regimen, with com-parison of serological non-responders and serological responders

    Within 9. month from 1. vaccination

  • Establish a rapid test for measuring HBsAg specific CMI by use of an IFN-gamma based assay.

    18 month after 1. vaccination

Study Arms (1)

HBsAg

OTHER
Biological: Twinrix

Interventions

TwinrixBIOLOGICAL

A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Twinrix ® Adult suspension for injection. 1 ml contains 720 ELISA units of hepatitis A virus antigen adsorbed to aluminum hydroxide and 20 micrograms hepatitis B surface antigen (HBsAg) adsorbed to aluminum phosphate in sterile water. Excipient: sodium chloride. Contains traces of neomycin.

HBsAg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed participant information and consent
  • Age over 18 years
  • Women of childbearing potential must use effective contraceptives

You may not qualify if:

  • previous HBV infection
  • previous HBV immunization
  • pregnancy (or planned pregnancy within 6 months)
  • allergy to contents in the vaccine (formaldehyde).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

twinrix

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lars Østergaard, Head

    Department of Infectious Diseases, Aarhus University Hospital

    STUDY CHAIR

  • Søren Jensen-Fangel, MD

    Department of Infectious Diseases, Aarhus University Hospital

    STUDY DIRECTOR

  • Martin Tolstrup, MSc

    Department of Infectious Diseases, Aarhus University Hospital

    STUDY DIRECTOR

  • Maria B Pedersen, Bach.Med

    Department of Infectious Diseases, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

DK(1)