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

NCT02255227 | Terminated Phase 2

• 2 other identifiers: 13081622013-004609-19
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

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

Keywords

vaccination; randomized; anti-pneumococcal; Pneumo 23; Prevenar 13; Chronic Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients with local and/or general reaction

  Months 1, 3 and 5

• Number of patients with inflammatory disease activity

  Months 1, 3, 4, 5, 12, 18, 36

• Factors implicated in anti-pneumococcal vaccination efficacy

  Month 0

• number of patients with serotype coverage of PSV-23

  Months 5, 12, 18 and 36

Study Arms (2)

1 dose Prevenar13 and 1 dose PSV23

ACTIVE COMPARATOR

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

Biological: Prevenar 13; Biological: Pneumo 23

2 doses Prevenar13 and 1 dose PSV23

EXPERIMENTAL

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; Biological: Pneumo 23

Interventions

Prevenar 13 BIOLOGICAL

one dose for arm 1 and 2 doses for arm 2

1 dose Prevenar13 and 1 dose PSV23; 2 doses Prevenar13 and 1 dose PSV23

Pneumo 23 BIOLOGICAL

one dose

1 dose Prevenar13 and 1 dose PSV23; 2 doses Prevenar13 and 1 dose PSV23

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient with social coverage

You may not qualify if:

• Patients vaccinated against pneumo23 for less than 5 years
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Pfizer: collaborator

Study Sites (8)

CHU Amiens-Picardie

Amiens, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Saint-Eloi

Montpellier, 34295, France

Location

Hôpital de l'Archet II

Nice, 06202, France

Location

APHP - Hôpital Cochin

Paris, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pneumococcal Infections; Inflammatory Bowel Diseases

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xavier Roblin, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 2, 2014
• Study Start: April 13, 2015
• Primary Completion: August 6, 2019
• Study Completion: July 6, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

FR (8)