Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Aarhus
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed participant information and consent
- •Age over 18 years
- •Women of childbearing potential must use effective contraceptives
Exclusion Criteria
- •previous HBV infection
- •previous HBV immunization
- •pregnancy (or planned pregnancy within 6 months)
- •allergy to contents in the vaccine (formaldehyde).
Outcomes
Primary Outcomes
Estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
Time Frame: within 9. month from 1. vaccination
Preparation of peripheral blood mononuclear cells (PBMC) Optimisation of antigen-specific cytokine flow cytometry Quantification of IFN-γ producing CD4+ T cells
Secondary Outcomes
- 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)