Cystic FibrosisNCT02605538
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
A study testing Vaccination with vaccine against hepatitis A and B in people with Cystic Fibrosis and Hepatitis A, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Hepatitis A, Hepatitis B
- What is being tested?
- Vaccination with vaccine against hepatitis A and B
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2015to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CF patients not previously immunized against hepatitis A or B
- Healthy volunteers not previously immunized against hepatitis A or B
- Age over 1 year
Who cannot join
- Previously transplanted patients
- Previous vaccination with hepatitis vaccine
- Known allergy against components in Twinrix (TM)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Stockholm CF Center, KArolinska University Hospital
Stockholm, 14186
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis
- Being tested
- Vaccination with vaccine against hepatitis A and B
- Medical subject headings
- Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with vaccine against hepatitis A and BBiological
Also called Twinrix (TM)
Vaccination against hepatitis A and B
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis | Active comparator | 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. Receives: Biological: Vaccination with vaccine against hepatitis A and B |
| Healthy volunteers | Active comparator | 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. Receives: Biological: Vaccination with vaccine against hepatitis A and B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
Measured: 6 months for vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start1 Sep 2015
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Time and resource deficiency at the Stockholm CF Center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Ferenc Karpati, MD, Karolinska University Hospital
- Investigators
- Ferenc Karpati, MD, PhD, Principal investigator, Stockholm CF Center, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605538
- Sponsor's protocol ID
- 2012/251-31/2
- Status last verified
- Mar 2024
- First submitted
- 4 May 2015
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
- ClinicalTrials.gov ID
- NCT02605538
- Acronym / sponsor ID
- 2012/251-31/2
- Conditions
- Cystic Fibrosis, Hepatitis A, Hepatitis B, Tuberculosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Time and resource deficiency at the Stockholm CF Center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis | Active comparator | Biological: Vaccination with vaccine against hepatitis A and BVaccination 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. |
| Healthy volunteers | Active comparator | Biological: Vaccination with vaccine against hepatitis A and BVaccination 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- CF patients not previously immunized against hepatitis A or B
- Healthy volunteers not previously immunized against hepatitis A or B
- Age over 1 year
Key exclusion criteria (3 listed)
- Previously transplanted patients
- Previous vaccination with hepatitis vaccine
- Known allergy against components in Twinrix (TM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination with vaccine against hepatitis A and BAlso: Twinrix (TM)Vaccination against hepatitis A and B | Biological | Cystic Fibrosis, Healthy volunteers |
Primary outcome
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers
Time frame: 6 months for vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferenc Karpati, MD, PhD principal investigator
Stockholm CF Center, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination with vaccine against hepatitis A and B in people with Cystic Fibrosis and Hepatitis A, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers (time frame: 6 months for vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.