Overview

This trial is active, not recruiting.

Condition hepatitis b
Treatment twinrix
Phase phase 4
Sponsor University of Aarhus
Collaborator Aarhus University Hospital
Start date October 2011
End date July 2013
Trial size 400 participants
Trial identifier NCT01451801, SJF0001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
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.

Primary Outcomes

Measure
Estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
time frame: 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
time frame: Within 9 month from 1. vaccination
Assess the safety of the vaccine by evaluating the numbers and intensity of adverse and Serious adverse events
time frame: Within 9 month from 1. vaccination
Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization
time frame: 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
time frame: Within 9. month from 1. vaccination
Establish a rapid test for measuring HBsAg specific CMI by use of an IFN-gamma based assay.
time frame: 18 month after 1. vaccination

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
Principal investigator Maria B Pedersen, Bach.Med
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Aarhus.