Crohn's DiseasePhase 4NCT01505855
Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
A Phase 4 study testing 23-valent polysaccharide pneumococcal vaccine in people with Crohn's Disease, run by Kyunghee University Medical Center at 15 sites in South Korea.
Trial summary
A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 23-valent polysaccharide pneumococcal vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Dec 2011to Jun 2013
- 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
- Patients over the age of 18
- Informed consent
- Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)
Who cannot join
- Hypersensitivity to any component of the pneumococcal vaccine
- Known allergy to pneumococcal vaccination
- Patients who treated with glucocorticoids (prednisolone > 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping
- Patients who inoculate another vaccine in the past 4 weeks
- Significant protein calorie malnutrition
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, infectious, neurologic or cerebral disease
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Kosin University Gospel Hospital
Busan
Soonchunhyang University
Cheonan
Keimyung University; Dongsan Hospital
Daegu
Wonkwang University
Iksan
Kyung Hee University Hospital
Seoul, 130-702
Asan Medical Center
Seoul
Chung-Ang University
Seoul
Ewha Womans University
Seoul
Inje University; Seoul Paik Hospital
Seoul
Konkuk University Hospital
Seoul
Korea University; Ansan Hospital
Seoul
Seoul National University Hospital
Seoul
Yonsei University; Severance Hospital
Seoul
The Catholic University of Korea; St. Vincent's Hospital
Suwon
Yonsei University: Wonju Christian Hospital
Wŏnju, Gangwon-do, 220-701
About this study
Official title: Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study
A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
- Conditions
- Crohn's Disease
- Being tested
- 23-valent polysaccharide pneumococcal vaccine
- Keywords
- Crohn's disease, Pneumococcal vaccination
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent polysaccharide pneumococcal vaccineDrug
Also called Pneumovax
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| anti-TNF only | Experimental | Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only Receives: Drug: 23-valent polysaccharide pneumococcal vaccine |
| Combined immunosuppression | Experimental | Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP]) Receives: Drug: 23-valent polysaccharide pneumococcal vaccine |
| Immunomodulator only | Experimental | Crohn's disease, on an immunomodulator only Receives: Drug: 23-valent polysaccharide pneumococcal vaccine |
| Non-immunosuppression | Experimental | Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm) Receives: Drug: 23-valent polysaccharide pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological response rates
Serological response rates, defined by number of patients showing adequate response to pneumococcal vaccination (at least a 2-fold increase in antipneumococcal antibodies in the serum compared with baseline)
Measured: 4 weeks
Secondary outcomes (1)
Safety assessment of the vaccine
adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn's 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Seoul National University Hospital, Asan Medical Center, Soonchunhyang University Hospital, Ewha Womans University, Kosin University Gospel Hospital, Chung-Ang University Hospital, Inje University, The Catholic University of Korea, Keimyung University Dongsan Medical Center, Korea University, Wonkwang University, Severance Hospital, Konkuk University Hospital
- Responsible party
- Principal investigator, Chang Kyun Lee, Kyunghee University Medical Center
- Investigators
- Hyun-Soo Kim, MD, PhD, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505855
- Sponsor's protocol ID
- CD vaccination 1.2
- Status last verified
- Oct 2014
- First submitted
- 2 Jan 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melmed GY, Agarwal N, Frenck RW, Ippoliti AF, Ibanez P, Papadakis KA, Simpson P, Barolet-Garcia C, Ward J, Targan SR, Vasiliauskas EA. Immunosuppression impairs response to pneumococcal polysaccharide vaccination in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 Jan;105(1):148-54. doi: 10.1038/ajg.2009.523. Epub 2009 Sep 15.
PubMed 19755964Fiorino G, Peyrin-Biroulet L, Naccarato P, Szabo H, Sociale OR, Vetrano S, Fries W, Montanelli A, Repici A, Malesci A, Danese S. Effects of immunosuppression on immune response to pneumococcal vaccine in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2012 Jun;18(6):1042-7. doi: 10.1002/ibd.21800. Epub 2011 Jun 14.
PubMed 21674732Wasan SK, Coukos JA, Farraye FA. Vaccinating the inflammatory bowel disease patient: deficiencies in gastroenterologists knowledge. Inflamm Bowel Dis. 2011 Dec;17(12):2536-40. doi: 10.1002/ibd.21667. Epub 2011 Apr 28.
PubMed 21538710
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01505855
- Acronym / sponsor ID
- CD vaccination 1.2
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Pneumococcal vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Seoul National University Hospital, Asan Medical Center, Soonchunhyang University Hospital, Ewha Womans University, Kosin University Gospel Hospital, Chung-Ang University Hospital, Inje University, The Catholic University of Korea, Keimyung University Dongsan Medical Center, Korea University, Wonkwang University, Severance Hospital, Konkuk University Hospital
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jan 2012 (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.
A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| anti-TNF only | Experimental | Drug: 23-valent polysaccharide pneumococcal vaccineCrohn's disease, on an anti-TNF agent [infliximab or adalimumab] only |
| Combined immunosuppression | Experimental | Drug: 23-valent polysaccharide pneumococcal vaccineCrohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP]) |
| Immunomodulator only | Experimental | Drug: 23-valent polysaccharide pneumococcal vaccineCrohn's disease, on an immunomodulator only |
| Non-immunosuppression | Experimental | Drug: 23-valent polysaccharide pneumococcal vaccineCrohn's disease, not on immunosuppressive medications (5-ASA only: control arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18
- Informed consent
- Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)
Key exclusion criteria (7 listed)
- Hypersensitivity to any component of the pneumococcal vaccine
- Known allergy to pneumococcal vaccination
- Patients who treated with glucocorticoids (prednisolone > 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping
- Patients who inoculate another vaccine in the past 4 weeks
- Significant protein calorie malnutrition
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 |
|---|---|---|
| 23-valent polysaccharide pneumococcal vaccineAlso: Pneumovax23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection | Drug | Combined immunosuppression, Immunomodulator only, Non-immunosuppression, anti-TNF only |
Primary outcome
Serological response rates
Time frame: 4 weeks
Serological response rates, defined by number of patients showing adequate response to pneumococcal vaccination (at least a 2-fold increase in antipneumococcal antibodies in the serum compared with baseline)
1 secondary outcome
Safety assessment of the vaccine
Time frame: 8 weeks
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 16 Oct 2014.
- Background: PubMed 19755964Melmed GY, Agarwal N, Frenck RW, Ippoliti AF, Ibanez P, Papadakis KA, Simpson P, Barolet-Garcia C, Ward J, Targan SR, Vasiliauskas EA. Immunosuppression impairs response to pneumococcal polysaccharide vaccination in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 Jan;105(1):148-54. doi: 10.1038/ajg.2009.523. Epub 2009 Sep 15.
- Background: PubMed 21674732Fiorino G, Peyrin-Biroulet L, Naccarato P, Szabo H, Sociale OR, Vetrano S, Fries W, Montanelli A, Repici A, Malesci A, Danese S. Effects of immunosuppression on immune response to pneumococcal vaccine in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2012 Jun;18(6):1042-7. doi: 10.1002/ibd.21800. Epub 2011 Jun 14.
- Background: PubMed 21538710Wasan SK, Coukos JA, Farraye FA. Vaccinating the inflammatory bowel disease patient: deficiencies in gastroenterologists knowledge. Inflamm Bowel Dis. 2011 Dec;17(12):2536-40. doi: 10.1002/ibd.21667. Epub 2011 Apr 28.
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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.
Hyun-Soo Kim, MD, PhD study chair
Yonsei University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 23-valent polysaccharide pneumococcal vaccine in people with Crohn's Disease, run by Kyunghee University Medical Center at 15 sites in South Korea.
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 7 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. 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?
Serological response rates (time frame: 4 weeks). 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 NCT01505855, which also lists 3 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 16 Oct 2014.