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More info
You can access this
clinical trial
if you have
Hepatitis B
and you are
over 18
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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.

Provided treatments

  • Biological: Twinrix

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01451801. The sponsor of the trial is University of Aarhus and it is looking for 400 volunteers for the current phase.
Official trial title:
Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders