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Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Sponsor
Karolinska University Hospital (Other)
Overall Status
Suspended
CT.gov ID
NCT02605538
Collaborator
Karolinska Institutet (Other)
250
Enrollment
1
Location
2
Arms
124
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Vaccination with vaccine against hepatitis A and B
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
Actual Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers [6 months for vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stockholm CF Center, KArolinska University Hospital Stockholm Sweden 14186

    Sponsors and Collaborators

    • Karolinska University Hospital
    • Karolinska Institutet

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferenc Karpati, MD, MD, PhD, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT02605538
    Other Study ID Numbers:
    • 2012/251-31/2
    First Posted:
    Nov 16, 2015
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Tuberculosis
    Latent Tuberculosis
    Hepatitis
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Apr 8, 2022