Crohns DiseasePhase 4PneuVACNCT01947010
Pneumococcal Vaccination of Crohn Patients
A Phase 4 study testing Prevenar 13 and Pneumovax in people with Crohns Disease, run by Statens Serum Institut at 1 site in Denmark.
Trial summary
Inflammatory bowel disease (IBD) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine and or TNF-a inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Prevenar 13 and Pneumovax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Aug 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease, receive immunosuppressive treatment or no treatment
Who cannot join
- <18 years of age,
- pregnant,
- anemia,
- previously pneumococcus vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease
Inflammatory bowel disease (IBD) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine and or TNF-a inhibitors.
Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23 valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal vaccines (PCV13).
In this study the investigators wish to study the effect of pneumococcal vaccination with either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or untreated.
Read the detailed description
Patients with autoimmune diseases like inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs. Different drugs are well-known suppressors of the immune system: Prednisolone, Azathioprine, Methotrexate (MTX), TNF-a inhibitors, and the newer biological agents such as, e.g., Rituximab (RTX), which is a drug used in the treatment of RA patients often in combination with MTX. The extent of immunosuppression induced by these therapeutic agents seems to depend, to some extent, on pharmacological dose/response relationships and on the combination of drugs, but individual variability plays a major role as well.
Prophylactic measures such as vaccination, quick upstart of antibiotics in case of fever and general information to patients about how to handle fever etc. are important in order to prevent as many cases of serious infections as possible among patients in immunosuppressive treatment.
Streptococcus pneumoniae is a cause of worldwide morbidity and mortality. Pneumococcal vaccines have been available since the early 1980's. The vaccine which has been licensed for immunization of children >2 years and adults is a polysaccharide-based vaccine (23PPV) consisting of capsule parts of the 23 most frequent serotypes of pneumococci. This vaccine elicits in normal immunocompetent persons a high antibody response, which lasts for approximately 10 years. Because the 23PPV is a polysaccharide-based vaccine, it induces a T-cell independent response with no memory and there-fore with no possibility of boosting. In 2001, the first generation of conjugate pneumococcal vaccines (PCV7) was licensed. In the PCV's, the capsule material from the pneumococci has been conjugated to a protein, which means that the vaccines can elicit a T-cell dependent immune response even in infants giving memory response and booster possibility. This vaccine has been licensed for use in children from 0-5 years, but studies suggest that PCV immunization might be useful in other groups of people as well etc. immunodeficient children and adults (especially now where the second-generation vaccines PCV10, PCV13 have been licensed covering more pneumococcal serotypes).
Some studies have shown that patients treated with immunosuppressive drugs cannot mount a sufficient antibody response upon vaccination whereas other studies suggest that these patient groups do respond to conventional vaccination.
It is recommended in the Danish guidelines for pneumococcal vaccination, that elderly patients with chronic diseases and patients with a decreased immune system are vaccinated against pneumococcal diseases. Accordingly, patients with Crohn's disease treated with TNF-a inhibitors are recommended pneumococcal vaccination.
In this study, the investigators aim to carry out an investigation of the response to pneumococcal vaccination in persons with Crohn's disease treated with TNF-a inhibitors and/or azathioprine, in order to determine if there is a place for the usage of conjugate vaccination in these patient groups.
- Conditions
- Crohns Disease
- Being tested
- Prevenar 13, Pneumovax
- Keywords
- antibodies
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13Biological
PneumovaxBiological
| Study group | Role | What they receive |
|---|---|---|
| Crohn's patients treated with Azathioprine | Active comparator | Vaccination with PPV23 or Vaccination with PCV 13 Receives: Biological: Prevenar 13; Biological: Pneumovax |
| Crohn's patients treated with Azathioprine and TNFa inhibitors | Active comparator | Vaccination with PPV23 or Vaccination with PCV 13 Receives: Biological: Prevenar 13; Biological: Pneumovax |
| Crohn's disease patients without treatment | Active comparator | Vaccination with PPV23 or Vaccination with PCV 13 Receives: Biological: Prevenar 13; Biological: Pneumovax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antibody titers
The primary outcome is to detect a difference in antibody change between the two vaccines as a consequence of the vaccination
Measured: Day 0, 4 weeks post vaccination, 1 year post vaccination
Secondary outcomes (1)
Change in antibody titers as a function of Crohns disease treatment
The secondary outcome is to detect a difference in antibody change between the two vaccines as a function of the treatment for Crohns disease.
Measured: Day 0, 4 weeks post vaccination, 1 year post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Andreas M Petersen, MD, Principal investigator, Hvidovre University HospitalOle Ø Thomsen, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947010
- Sponsor's protocol ID
- BJK001
- Acronym
- PneuVAC
- Status last verified
- Feb 2015
- First submitted
- 9 Sep 2013
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kantso B, Halkjaer SI, Ostergaard Thomsen O, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Persistence of antibodies to pneumococcal conjugate vaccine compared to polysaccharide vaccine in patients with Crohn's disease - one year follow up. Infect Dis (Lond). 2019 Sep;51(9):651-658. doi: 10.1080/23744235.2019.1638519. Epub 2019 Jul 10.
PubMed 31290715Kantso B, Halkjaer SI, Thomsen OO, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Immunosuppressive drugs impairs antibody response of the polysaccharide and conjugated pneumococcal vaccines in patients with Crohn's disease. Vaccine. 2015 Oct 5;33(41):5464-5469. doi: 10.1016/j.vaccine.2015.08.011. Epub 2015 Aug 12.
PubMed 26275480
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01947010
- Acronym / sponsor ID
- PneuVAC / BJK001
- Conditions
- Crohns Disease
- Keywords
- antibodies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Herlev Hospital
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Sep 2013 (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.
Inflammatory bowel disease (IBD) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine and or TNF-a inhibitors.
Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23 valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal vaccines (PCV13).
In this study the investigators wish to study the effect of pneumococcal vaccination with either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or untreated.
Detailed description
Patients with autoimmune diseases like inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs. Different drugs are well-known suppressors of the immune system: Prednisolone, Azathioprine, Methotrexate (MTX), TNF-a inhibitors, and the newer biological agents such as, e.g., Rituximab (RTX), which is a drug used in the treatment of RA patients often in combination with MTX. The extent of immunosuppression induced by these therapeutic agents seems to depend, to some extent, on pharmacological dose/response relationships and on the combination of drugs, but individual variability plays a major role as well.
Prophylactic measures such as vaccination, quick upstart of antibiotics in case of fever and general information to patients about how to handle fever etc. are important in order to prevent as many cases of serious infections as possible among patients in immunosuppressive treatment.
Streptococcus pneumoniae is a cause of worldwide morbidity and mortality. Pneumococcal vaccines have been available since the early 1980's. The vaccine which has been licensed for immunization of children >2 years and adults is a polysaccharide-based vaccine (23PPV) consisting of capsule parts of the 23 most frequent serotypes of pneumococci. This vaccine elicits in normal immunocompetent persons a high antibody response, which lasts for approximately 10 years. Because the 23PPV is a polysaccharide-based vaccine, it induces a T-cell independent response with no memory and there-fore with no possibility of boosting. In 2001, the first generation of conjugate pneumococcal vaccines (PCV7) was licensed. In the PCV's, the capsule material from the pneumococci has been conjugated to a protein, which means that the vaccines can elicit a T-cell dependent immune response even in infants giving memory response and booster possibility. This vaccine has been licensed for use in children from 0-5 years, but studies suggest that PCV immunization might be useful in other groups of people as well etc. immunodeficient children and adults (especially now where the second-generation vaccines PCV10, PCV13 have been licensed covering more pneumococcal serotypes).
Some studies have shown that patients treated with immunosuppressive drugs cannot mount a sufficient antibody response upon vaccination whereas other studies suggest that these patient groups do respond to conventional vaccination.
It is recommended in the Danish guidelines for pneumococcal vaccination, that elderly patients with chronic diseases and patients with a decreased immune system are vaccinated against pneumococcal diseases. Accordingly, patients with Crohn's disease treated with TNF-a inhibitors are recommended pneumococcal vaccination.
In this study, the investigators aim to carry out an investigation of the response to pneumococcal vaccination in persons with Crohn's disease treated with TNF-a inhibitors and/or azathioprine, in order to determine if there is a place for the usage of conjugate vaccination in these patient groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's patients treated with Azathioprine | Active comparator | Biological: Prevenar 13, Biological: PneumovaxVaccination with PPV23 or Vaccination with PCV 13 |
| Crohn's patients treated with Azathioprine and TNFa inhibitors | Active comparator | Biological: Prevenar 13, Biological: PneumovaxVaccination with PPV23 or Vaccination with PCV 13 |
| Crohn's disease patients without treatment | Active comparator | Biological: Prevenar 13, Biological: PneumovaxVaccination with PPV23 or Vaccination with PCV 13 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Crohn's disease, receive immunosuppressive treatment or no treatment
Key exclusion criteria (4 listed)
- <18 years of age,
- pregnant,
- anemia,
- previously pneumococcus vaccination
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 |
|---|---|---|
| Prevenar 13 | Biological | Crohn's disease patients without treatment, Crohn's patients treated with Azathioprine, Crohn's patients treated with Azathioprine and TNFa inhibitors |
| Pneumovax | Biological | Crohn's disease patients without treatment, Crohn's patients treated with Azathioprine, Crohn's patients treated with Azathioprine and TNFa inhibitors |
Primary outcome
Change in antibody titers
Time frame: Day 0, 4 weeks post vaccination, 1 year post vaccination
The primary outcome is to detect a difference in antibody change between the two vaccines as a consequence of the vaccination
1 secondary outcome
Change in antibody titers as a function of Crohns disease treatment
Time frame: Day 0, 4 weeks post vaccination, 1 year post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Derived from this study: PubMed 31290715Kantso B, Halkjaer SI, Ostergaard Thomsen O, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Persistence of antibodies to pneumococcal conjugate vaccine compared to polysaccharide vaccine in patients with Crohn's disease - one year follow up. Infect Dis (Lond). 2019 Sep;51(9):651-658. doi: 10.1080/23744235.2019.1638519. Epub 2019 Jul 10.
- Derived from this study: PubMed 26275480Kantso B, Halkjaer SI, Thomsen OO, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Immunosuppressive drugs impairs antibody response of the polysaccharide and conjugated pneumococcal vaccines in patients with Crohn's disease. Vaccine. 2015 Oct 5;33(41):5464-5469. doi: 10.1016/j.vaccine.2015.08.011. Epub 2015 Aug 12.
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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.
Andreas M Petersen, MD principal investigator
Hvidovre University Hospital
Ole Ø Thomsen, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar 13 and Pneumovax in people with Crohns Disease, run by Statens Serum Institut at 1 site in Denmark.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in antibody titers (time frame: Day 0, 4 weeks post vaccination, 1 year post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947010, which also lists 2 linked publications.
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 10 Feb 2015.