Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD (PneumoMICI)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Terminated; Phase 2

Conditions: Infections, Pneumococcal; Bowel Diseases, Inflammatory

Treatments: Biological: Pneumo 23; Biological: Prevenar 13

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02255227

2013-004609-19 (EudraCT Number)

1308162

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

1 dose Prevenar13 and 1 dose PSV23

Active Comparator group

Description:

one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4

Treatment:

Biological: Prevenar 13

Biological: Pneumo 23

2 doses Prevenar13 and 1 dose PSV23

Experimental group

Description:

one dose of the polysaccharide vaccine, Prevenar 13 at M0, one dose of the polysaccharide vaccine, Prevenar 13, at M2 and one dose of polysaccharide vaccine, Pneumo 23 at M4

Treatment:

Biological: Prevenar 13

Biological: Pneumo 23