Infections, Pneumococcal, Bowel Diseases, Inflammatory
Conditions
Keywords
vaccination, randomized, anti-pneumococcal, Pneumo 23, Prevenar 13, 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.
Interventions
BIOLOGICALPrevenar 13
one dose for arm 1 and 2 doses for arm 2
BIOLOGICALPneumo 23
one dose
Sponsors
Pfizer
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with anti-pneumococcal immunogenicity | month 5 | Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with local and/or general reaction | Months 1, 3 and 5 | self monitoring diary |
| Number of patients with inflammatory disease activity | Months 1, 3, 4, 5, 12, 18, 36 | by clinic score HBI or CDAI or Mayo |
| Factors implicated in anti-pneumococcal vaccination efficacy | Month 0 | questionnaire |
| number of patients with serotype coverage of PSV-23 | Months 5, 12, 18 and 36 | Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method |
Countries
France
Outcome results
None listed