Status:
UNKNOWN
Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Monash Medical Centre
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-res...
Eligibility Criteria
Inclusion
- Signed participant information and consent
- Age over 18 years
- Women of childbearing potential must use effective contraceptives
Exclusion
- previous HBV infection
- previous HBV immunization
- pregnancy (or planned pregnancy within 6 months)
- allergy to contents in the vaccine (formaldehyde).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01451801
Start Date
October 1 2011
End Date
July 1 2013
Last Update
October 26 2012
Active Locations (1)
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1
Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, Denmark, 8200