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

Primary Purpose

Infections, Pneumococcal, Bowel Diseases, Inflammatory

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Prevenar 13
Pneumo 23
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Pneumococcal focused on measuring vaccination, randomized, anti-pneumococcal, Pneumo 23, Prevenar 13, Chronic Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens-Picardie
  • Hôpital Jean Minjoz
  • Hôpital Saint-Eloi
  • Hôpital de l'Archet II
  • APHP - Hôpital Cochin
  • Centre Hospitalier Lyon Sud
  • Hôpital Charles Nicolle
  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 dose Prevenar13 and 1 dose PSV23

2 doses Prevenar13 and 1 dose PSV23

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with local and/or general reaction
self monitoring diary
Number of patients with inflammatory disease activity
by clinic score HBI or CDAI or Mayo
Factors implicated in anti-pneumococcal vaccination efficacy
questionnaire
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

Full Information

First Posted
September 26, 2014
Last Updated
June 13, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02255227
Brief Title
Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
low inclusion rates
Study Start Date
April 13, 2015 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Pneumococcal, Bowel Diseases, Inflammatory
Keywords
vaccination, randomized, anti-pneumococcal, Pneumo 23, Prevenar 13, Chronic Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 dose Prevenar13 and 1 dose PSV23
Arm Type
Active Comparator
Arm Description
one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4
Arm Title
2 doses Prevenar13 and 1 dose PSV23
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Intervention Description
one dose for arm 1 and 2 doses for arm 2
Intervention Type
Biological
Intervention Name(s)
Pneumo 23
Intervention Description
one dose
Primary Outcome Measure Information:
Title
number of patients with anti-pneumococcal immunogenicity
Description
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
Time Frame
month 5
Secondary Outcome Measure Information:
Title
Number of patients with local and/or general reaction
Description
self monitoring diary
Time Frame
Months 1, 3 and 5
Title
Number of patients with inflammatory disease activity
Description
by clinic score HBI or CDAI or Mayo
Time Frame
Months 1, 3, 4, 5, 12, 18, 36
Title
Factors implicated in anti-pneumococcal vaccination efficacy
Description
questionnaire
Time Frame
Month 0
Title
number of patients with serotype coverage of PSV-23
Description
Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method
Time Frame
Months 5, 12, 18 and 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Roblin, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital de l'Archet II
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
APHP - Hôpital Cochin
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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