Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Hepatitis A Hepatitis B Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cystic Fibrosis

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Group Type ACTIVE_COMPARATOR

Vaccination with vaccine against hepatitis A and B

Intervention Type BIOLOGICAL

Vaccination against hepatitis A and B

Healthy volunteers

Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.

Group Type ACTIVE_COMPARATOR

Vaccination with vaccine against hepatitis A and B

Intervention Type BIOLOGICAL

Vaccination against hepatitis A and B

Interventions

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Vaccination with vaccine against hepatitis A and B

Vaccination against hepatitis A and B

Intervention Type BIOLOGICAL

Other Intervention Names

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Twinrix (TM)

Eligibility Criteria

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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