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

Bowel Diseases, Inflammatory Clinical Trial

— PneumoMICI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02255227
• Other study ID #: 1308162
• Secondary ID: 2013-004609-19
• Status: Terminated
• Phase: Phase 2
• Start date: April 13, 2015
• Est. completion date: July 6, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: July 6, 2022
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Diseases, Inflammatory
• Infections, Pneumococcal
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pneumococcal Infections

Intervention

Biological:
• Prevenar 13
one dose for arm 1 and 2 doses for arm 2
• Pneumo 23
one dose

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with anti-pneumococcal immunogenicity	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	month 5
Secondary	Number of patients with local and/or general reaction	self monitoring diary	Months 1, 3 and 5
Secondary	Number of patients with inflammatory disease activity	by clinic score HBI or CDAI or Mayo	Months 1, 3, 4, 5, 12, 18, 36
Secondary	Factors implicated in anti-pneumococcal vaccination efficacy	questionnaire	Month 0
Secondary	number of patients with serotype coverage of PSV-23	Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method	Months 5, 12, 18 and 36