Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Karolinska University Hospital

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Cystic Fibrosis Hepatitis A Hepatitis B Tuberculosis

Interventions

Vaccination with vaccine against hepatitis A and BBIOLOGICAL

Vaccination against hepatitis A and B

Eligibility

Sex: ALLMin age: 1 YearHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Stockholm CF Center, KArolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers

Time frame: 6 months for vaccination

Data from ClinicalTrials.gov

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