Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
NCT ID: NCT01451801
Last Updated: 2012-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2011-10-31
2013-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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HBsAg
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years
* Women of childbearing potential must use effective contraceptives
Exclusion Criteria
* previous HBV immunization
* pregnancy (or planned pregnancy within 6 months)
* allergy to contents in the vaccine (formaldehyde).
18 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Monash Medical Centre
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lars Østergaard, Head
Role: STUDY_CHAIR
Department of Infectious Diseases, Aarhus University Hospital
Søren Jensen-Fangel, MD
Role: STUDY_DIRECTOR
Department of Infectious Diseases, Aarhus University Hospital
Martin Tolstrup, MSc
Role: STUDY_DIRECTOR
Department of Infectious Diseases, Aarhus University Hospital
Maria B Pedersen, Bach.Med
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Aarhus University Hospital
Locations
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Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, , Denmark
Countries
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Other Identifiers
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SJF0001
Identifier Type: -
Identifier Source: org_study_id