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

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ClinicalTrials.gov Identifier: NCT02255227
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Infections, Pneumococcal Bowel Diseases, Inflammatory Biological: Prevenar 13 Biological: Pneumo 23 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 13, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
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
Biological: Prevenar 13
one dose for arm 1 and 2 doses for arm 2

Biological: Pneumo 23
one dose

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

Biological: Pneumo 23
one dose




Primary Outcome Measures :
  1. number of patients with anti-pneumococcal immunogenicity [ Time Frame: month 5 ]
    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 :
  1. Number of patients with local and/or general reaction [ Time Frame: Months 1, 3 and 5 ]
    self monitoring diary

  2. Number of patients with inflammatory disease activity [ Time Frame: Months 1, 3, 4, 5, 12, 18, 36 ]
    by clinic score HBI or CDAI or Mayo

  3. Factors implicated in anti-pneumococcal vaccination efficacy [ Time Frame: Month 0 ]
    questionnaire

  4. number of patients with serotype coverage of PSV-23 [ Time Frame: Months 5, 12, 18 and 36 ]
    Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255227


Contacts
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Contact: Xavier ROBLIN, MD (0)477828985 ext +33 xavier.roblin@chu-st-etienne.fr

Locations
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France
CHU Amiens-Picardie Recruiting
Amiens, France
Contact: Mathurin FUMERY, MD         
Principal Investigator: Mathurin FUMERY, MD         
Sub-Investigator: Franck BRAZIER, MD         
Sub-Investigator: Julien LOREAU, MD         
Hôpital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Lucine Vuitton, PU PH         
Principal Investigator: Lucine Vuitton, MD         
Sub-Investigator: Stéphane Koch, MD         
Hôpital Saint-Eloi Not yet recruiting
Montpellier, France, 34295
Contact: Romain Alwegg, MD         
Principal Investigator: Romain Alwegg, MD         
Sub-Investigator: Florent Gonzalez, MD         
Sub-Investigator: Ludovic Caillo, MD         
Sub-Investigator: Guillaume Danan, MD         
Hôpital de l'Archet II Recruiting
Nice, France, 06202
Contact: Xavier Hebuterne, MD         
Principal Investigator: Xavier Hebuterne, PU-PH         
Sub-Investigator: Jérome Filippi, MD         
Sub-Investigator: Nadia Arab, MD         
APHP - Hôpital Cochin Recruiting
Paris, France
Principal Investigator: Odile Launay, PhD         
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France, 69310
Contact: Stéphane Nancey, PU PH         
Principal Investigator: Stéphane NANCEY, PU PH         
Sub-Investigator: Bernard FLOURIE, MD         
Sub-Investigator: Gilles Boschetti, MD         
Principal Investigator: Karine Stroeymeyt, MD         
Principal Investigator: Marion CHAUVENET, MD         
Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Guillaume Savoye, PU-PH         
Principal Investigator: Guillaume Savoye, PU-PH         
Sub-Investigator: Laura Armengol-Debeir, MD         
Sub-Investigator: Lucile Moreau-Grange, MD         
CHU de Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Xavier ROBLIN         
Principal Investigator: Xavier ROBLIN, PhD         
Sub-Investigator: Frederic Lucht, PhD         
Sub-Investigator: Claire Guglielminotti, MD         
Sub-Investigator: Christiane Defontaine, MD         
Sub-Investigator: Elisabeth Bothelo-Nevers, PhD         
Sub-Investigator: Pascale Fouilloux, MD         
Sub-Investigator: Amandine Gagneux-Brunon, MD         
Sub-Investigator: Emilie Del Tedesco, MD         
Sub-Investigator: Camille Jarlot, MD         
Sub-Investigator: Pauline Veyrard, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Pfizer
Investigators
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Principal Investigator: Xavier Roblin, MD CHU Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02255227     History of Changes
Other Study ID Numbers: 1308162
2013-004609-19 ( EudraCT Number )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
vaccination
randomized
anti-pneumococcal
Pneumo 23
Prevenar 13
Chronic Inflammatory Bowel Disease

Additional relevant MeSH terms:
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Streptococcal Infections
Intestinal Diseases
Inflammatory Bowel Diseases
Pneumococcal Infections
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs