Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
NCT02255227
ABOUT THIS STUDY
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- Patient who have given their written consent in a free and informed consent
- Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis or indeterminate colitis), and treated for at least 3 months by immunosuppressive therapy and /or biotherapies and in clinical remission for at least 3 months
- Patient agreeing to participate in the study throughout its duration and accepting the procedures related to the study
- Contraception that the investigator judges effective for the first 12 months of the trial, with a negative pregnancy test
- Women not planning to become pregnant in the 12 months following inclusion (M0)
- Patient with social coverage
- Patients vaccinated against pneumo23 for less than 5 years
- Other vaccination during the month before inclusion
- Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute
infection in the week before vaccination
- The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at
least 6 or CDAI > 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC
and indeterminate colitis)
- Patients with an ongoing pregnancy the day of vaccination
- Patient with a known history of neuropathy as Guillain-Barré syndrome.
- Patients with known infection with HIV and / or HBV (HBsAg positive) and / or HCV
- Patient with other severe immune deficiency
- Patients who received immunoglobulin infusions of blood products, or of monoclonal
antibodies (except anti-TNF) in the 3 months prior to vaccination
- Patient institutionalized, or deprived of liberty administrative or judicial
- Patients treated without immunosuppressive therapy or biotherapies
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Descriptive Information | |||||
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Brief Title ICMJE | Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD | ||||
Official Title ICMJE | Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease | ||||
Brief Summary | This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients. Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE | 104 | ||||
Original Estimated Enrollment ICMJE | 150 | ||||
Estimated Study Completion Date ICMJE | July 2022 | ||||
Actual Primary Completion Date | August 6, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02255227 | ||||
Other Study ID Numbers ICMJE | 1308162 2013-004609-19 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Saint Etienne | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |