Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis
Conditions
Brief summary
CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.
Detailed description
Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine. The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.
Interventions
BIOLOGICALVaccination with vaccine against hepatitis A and B
Vaccination against hepatitis A and B
Sponsors
Karolinska Institutet
Karolinska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* CF patients not previously immunized against hepatitis A or B * Healthy volunteers not previously immunized against hepatitis A or B * Age over 1 year
Exclusion criteria
* Previously transplanted patients * Previous vaccination with hepatitis vaccine * Known allergy against components in Twinrix (TM)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers | 6 months for vaccination |
Countries
Sweden
Outcome results
None listed