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

NCT ID: NCT02255227

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-13
• Study Completion Date: 2022-07-06

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.

Conditions

Infections, Pneumococcal; Bowel Diseases, Inflammatory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1 dose Prevenar13 and 1 dose PSV23

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

Group Type: ACTIVE_COMPARATOR

Prevenar 13

Intervention Type: BIOLOGICAL

one dose for arm 1 and 2 doses for arm 2

Pneumo 23

Intervention Type: BIOLOGICAL

one dose

2 doses Prevenar13 and 1 dose PSV23

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

Group Type: EXPERIMENTAL

Prevenar 13

Intervention Type: BIOLOGICAL

one dose for arm 1 and 2 doses for arm 2

Pneumo 23

Intervention Type: BIOLOGICAL

one dose

Interventions

Prevenar 13

one dose for arm 1 and 2 doses for arm 2

Intervention Type: BIOLOGICAL

Pneumo 23

one dose

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Roblin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Amiens-Picardie

Amiens, , France

Hôpital Jean Minjoz

Besançon, , France

Hôpital Saint-Eloi

Montpellier, , France

Hôpital de l'Archet II

Nice, , France

APHP - Hôpital Cochin

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Hôpital Charles Nicolle

Rouen, , France

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2013-004609-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1308162

Identifier Type: -

Identifier Source: org_study_id