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NCT02605538 Clinical Trial

Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Cystic Fibrosis Clinical Trial

Official title:
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02605538
Other study ID # 2012/251-31/2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date December 31, 2025

Study information
Verified date March 2024
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2025
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Vaccination with vaccine against hepatitis A and B
Vaccination against hepatitis A and B

Locations
Country Name City State
Sweden Stockholm CF Center, KArolinska University Hospital Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska University Hospital Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers 6 months for vaccination
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