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Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders

NCT01451801 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-10-26

No results posted yet for this study

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. To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization

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

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. Blood is drawn at 0 and 8 months from all participants. The blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.

Conditions

Interventions

BIOLOGICAL

Twinrix

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Monash Medical Centre

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lars Østergaard, Head · Department of Infectious Diseases, Aarhus University Hospital

  • Søren Jensen-Fangel, MD · Department of Infectious Diseases, Aarhus University Hospital

  • Martin Tolstrup, MSc · Department of Infectious Diseases, Aarhus University Hospital

  • Maria B Pedersen, Bach.Med · Department of Infectious Diseases, Aarhus University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451801 on ClinicalTrials.gov