Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease

1308162

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.

2015-04-13

2019-08-06

2022-07-06

Terminated

Early phase I

104

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

2023-06-15