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

NCT02255227

Last updated date
Study Location
Hôpital Jean Minjoz
Besançon, , 25030, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections, Inflammatory Bowel Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pneumococcal Infections, Inflammatory Bowel DiseasesAnti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
NCT02255227
  1. Besançon,
  2. Montpellier,
  3. Nice,
  4. Pierre Bénite,
  5. Rouen,
  6. Saint-Etienne,
  7. Paris,
  8. Amiens,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
Official Title  ICMJE Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Infections, Pneumococcal
  • Bowel Diseases, Inflammatory
Intervention  ICMJE
  • Biological: Prevenar 13
    one dose for arm 1 and 2 doses for arm 2
  • Biological: Pneumo 23
    one dose
Study Arms  ICMJE
  • Active Comparator: 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
    Interventions:
    • Biological: Prevenar 13
    • Biological: Pneumo 23
  • Experimental: 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
    Interventions:
    • Biological: Prevenar 13
    • Biological: Pneumo 23
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 24, 2020)
104
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2014)
150
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255227
Other Study ID Numbers  ICMJE 1308162
2013-004609-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Xavier Roblin, MDCHU Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP