Clinical trial NCT02255227: Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
Official title: Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infections, Pneumococcal
Bowel Diseases, Inflammatory
Keywords: vaccination
randomized
anti-pneumococcal
Pneumo 23
Prevenar 13
Chronic Inflammatory Bowel Disease
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-10-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: number of patients with anti-pneumococcal immunogenicity
timeFrame: month 5
Secondary outcomes:
measure: Number of patients with local and/or general reaction
timeFrame: Months 1, 3 and 5
measure: Number of patients with inflammatory disease activity
timeFrame: Months 1, 3, 4, 5, 12, 18, 36
measure: Factors implicated in anti-pneumococcal vaccination efficacy
timeFrame: Month 0
measure: number of patients with serotype coverage of PSV-23
timeFrame: Months 5, 12, 18 and 36
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Montpellier
country: France
facility: Hôpital Saint-Eloi
city: Nice
country: France
facility: Hôpital de l'Archet II
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Xavier Roblin, MD
role: PRINCIPAL_INVESTIGATOR
References: