Clinical trial NCT01451801: Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
Official title: Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Hepatitis B
non responders
cellular immune response
cytokines
predictors
HBsAg
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Monash Medical Centre
First posted: 2011-10-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
timeFrame: within 9. month from 1. vaccination
Secondary outcomes:
measure: Establish the prevalence of serological non-responders after a standard course of HBV vaccination defined by anti-HBs <10 mIU / ml
timeFrame: Within 9 month from 1. vaccination
measure: Assess the safety of the vaccine by evaluating the numbers and intensity of adverse and Serious adverse events
timeFrame: Within 9 month from 1. vaccination
measure: Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization
timeFrame: within 9 month from 1. vaccination
measure: Compare the immunological profile before and after a standard HBV vaccination regimen, with com-parison of serological non-responders and serological responders
timeFrame: Within 9. month from 1. vaccination
measure: Establish a rapid test for measuring HBsAg specific CMI by use of an IFN-gamma based assay.
timeFrame: 18 month after 1. vaccination
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Infectious Diseases, Aarhus University Hospital
Study officials:
affiliation: Department of Infectious Diseases, Aarhus University Hospital
name: Lars Østergaard, Head
role: STUDY_CHAIR
affiliation: Department of Infectious Diseases, Aarhus University Hospital
name: Søren Jensen-Fangel, MD
role: STUDY_DIRECTOR
affiliation: Department of Infectious Diseases, Aarhus University Hospital
name: Martin Tolstrup, MSc
role: STUDY_DIRECTOR
affiliation: Department of Infectious Diseases, Aarhus University Hospital
name: Maria B Pedersen, Bach.Med
role: PRINCIPAL_INVESTIGATOR
References: