anti-pneumococcal vaccine strategy in patients treated with immunosuppressants or biotherapies for cibd

Conditions: Infections, Pneumococcal; Bowel Diseases, Inflammatory

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.


Eligibility criteria:
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

Keywords: vaccination randomized anti-pneumococcal pneumo 23 prevenar 13 chronic inflammatory bowel disease