Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

March 15, 2024 updated by: Ferenc Karpati, MD, Karolinska University Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Stockholm CF Center, KArolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Biological: Vaccination with vaccine against hepatitis A and B
Vaccination against hepatitis A and B
Other Names:
  • Twinrix (TM)
Active Comparator: 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.
Biological: Vaccination with vaccine against hepatitis A and B
Vaccination against hepatitis A and B
Other Names:
  • Twinrix (TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
Time Frame: 6 months for vaccination
6 months for vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Ferenc Karpati, MD, PhD, Stockholm CF Center, KArolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimated)

November 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/251-31/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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