Status:
TERMINATED
Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Pfizer
Conditions:
Infections, Pneumococcal
Bowel Diseases, Inflammatory
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 immunosuppressan...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT02255227
Start Date
April 13 2015
End Date
July 6 2022
Last Update
June 15 2023
Active Locations (8)
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1
CHU Amiens-Picardie
Amiens, France
2
Hôpital Jean Minjoz
Besançon, France, 25030
3
Hôpital Saint-Eloi
Montpellier, France, 34295
4
Hôpital de l'Archet II
Nice, France, 06202