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Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Primary Purpose

Cystic Fibrosis, Hepatitis A, Hepatitis B

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Vaccination with vaccine against hepatitis A and B
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Stockholm CF Center, KArolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cystic Fibrosis

Healthy volunteers

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2015
Last Updated
March 30, 2022
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02605538
Brief Title
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
Official Title
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Suspended
Why Stopped
No active recruitment during the COVID pandemic. Time and resource deficiency at the Stockholm CF Center.
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cystic Fibrosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaccination with vaccine against hepatitis A and B
Other Intervention Name(s)
Twinrix (TM)
Intervention Description
Vaccination against hepatitis A and B
Primary Outcome Measure Information:
Title
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
Time Frame
6 months for vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferenc Karpati, MD, PhD
Organizational Affiliation
Stockholm CF Center, Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm CF Center, KArolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

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