Induction of Immunity Against Streptococcus Pneumoniae in Adults With Inflammatory Bowel Disease (PCV13inSIBDCS)

September 16, 2020 updated by: Klara M. Pósfay Barbe

Influence of Immunosuppressive Treatment on Immunological Response to Pneumococcal Conjugated Vaccine (PCV13) in Patients With Inflammatory Bowel Disease

Patients with inflammatory bowel disease are at increased risk for infections due to their baseline disease and the subsequent immunocompromising regimen. Streptococcus pneumoniae (pneumococcus) has a high mortality and morbidity, particularly in immunosuppressed patients. A polysaccharide vaccine covering 23 different serotypes of pneumococcus (PPSV23) is currently recommended to immunocompromised patients to reduce their risk of invasive pneumococcal infections (such as bacteremia, meningitis, or pneumonia). Its immunogenicity is however limited, both in magnitude and duration, even in healthy individuals. Several studies have investigated the immunogenicity of PPSV23 in patients with IBD and have reported a marked inhibitory effect of immunosuppressive therapy on vaccine responses.

A pneumococcal conjugated vaccine (PCV) was originally developed to protect young children and demonstrated as highly effective and safe. PCV13 contains polysaccharides from thirteen different serotypes, conjugated to an inactivated diphtheria toxin, and has the capacity to induce both primary and memory responses. PCV also appears much more immunogenic than PPSV23 in immunocompromised pediatric and adult patients. Whether some therapeutic regimens may nevertheless prevent the induction of protective responses by PCV13 is yet unknown.

To date, no study has yet reported the immunogenicity / safety of PCV13 in adult IBD patients.

Study's objectives

  • Primary objective: evaluate the immunogenicity and safety profile of PCV13 immunization in IBD patients
  • Secondary objective: evaluate the relative influence of treatment and disease on immune responses to PCV13 immunization
  • Tertiary objective: evaluate the immunity/vulnerability against vaccine-preventable diseases (VZV, measles) in the IBD cohort of Switzerland (optional, depending on funds)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A. Inclusion:

Patients are eligible for this study if they are part of the SIBDCS and are followed in Switzerland in Geneva, Vaud, Neuchatel or Bern. Gastroenterologist will present the study to the patient during a routine follow-up visit. Inclusion will be cumulative, into 2 groups of 150 patients without (Group 1) or with (Group 2) immunosuppressive treatments.

B. Intervention

  1. Vaccine history evaluation: A questionnaire will be filled at baseline including questions to establish patients' history of vaccine-preventable diseases and/or immunizations.
  2. Serologic evaluation: Blood will be taken at inclusion for a baseline serological evaluation against pneumococcus. Antibody analyses will be performed using enzyme linked immunosorbent assays (ELISA) to quantify antigen-specific immunoglobulin G (IgG) antibodies. Serological evaluation against tetanus, measles and VZV could be performed through a study extension, depending on funds available.

  3. Pneumococcal immunization: PCV13 (1 dose=0.5ml, intra-muscular) will be administrated during the same inclusion visit.

    Optional intervention (depending on available funds):

  4. Additional missing immunizations could be identified by the study team on an individualized level, based on the patient's immunological record, and presence or absence of immunosuppression.

C. Assessment of effectiveness:

A second blood sampling will be scheduled 2 months (minimum 1, maximum 4) after PCV13 administration and will to assess vaccine response to PCV13.

D. Assessment of safety:

Vaccine safety will be monitored using standardized diary cards recording local and systemic side effects at week 1, 2, 4, 6, 8 after immunization. Patient will also be contacted by phone at week 6 by the investigator who will ask standardized questions regarding vaccine safety. Potential changes in disease activity (vaccine-induced flares) will be monitored during the following 6 months, through data collected in the SIBDCS database.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • University Hospitals of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being part of the Swiss IBD Cohort Study
  • Being followed in Geneva, Neuchatel, Vaud or Bern
  • Adult >18 years-old
  • informed consent form signed
  • acceptance of PCV13 immunization

Exclusion Criteria:

  • Current relapse defined as a Crohn's Disease Activity Index (CDAI) >150 for patients with Crohn's disease or a Modified Truelove-Witts Activity Index (MTWAI) >10 for patients with ulcerative colitis
  • Actually pregnant or planned pregnancy in the next month
  • Immunization with a pneumococcal vaccine (conjugated or polysaccharide) in the previous 5 years
  • Previous severe systemic reaction to immunization (respiratory or circulative)
  • Episode of fever in the last 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient non immunosuppressed
Group 1 : patient without immunosuppressive treatment
Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
Immunization with 1 dose of PCV13 (=0.5ml) intra-muscular
Other Names:
  • Streptococcus pneumoniae conjugated vaccine
  • PCV13 (Prevenar13®, Pfizer AG, Zurich)
  • Swissmedic authorization number 60129
Experimental: Patient immunosuppressed
Group 2 : patient with immunosuppressive treatment
Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
Immunization with 1 dose of PCV13 (=0.5ml) intra-muscular
Other Names:
  • Streptococcus pneumoniae conjugated vaccine
  • PCV13 (Prevenar13®, Pfizer AG, Zurich)
  • Swissmedic authorization number 60129

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serologic response to PCV13 vaccine in patients with inflammatory bowel disease
Time Frame: 2 months after immunization
Patients with inflammatory bowel disease will receive the PCV13 vaccine and a blood sample scheduled 2 months after will evaluate vaccine responses.
2 months after immunization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of PCV13 administration in patients with inflammatory bowel disease
Time Frame: 6 months
The safety of the PCV13 immunization in patient with inflammatory bowel disease will be evaluated using standardized side effect card, standardized phone call and data on disease disease activity via the SIBDCS database.
6 months
Evaluate the relative influence of treatment and disease on immune responses to PCV13 immunization
Time Frame: 2 months
Mean pneumococcal antibody titers in Group 1 (patients without immunosuppressive treatments) and Group 2 (patients with immunosuppressive treatment) before and after immunization will be compared. Logistic regression will identify independent factor associated with seropositivity and magnitude of vaccine response.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klara M. Pósfay Barbe

Collaborators

Swiss IBD Cohort Study

Investigators

  • Principal Investigator: Klara M. Posfay-Barbe, MD, MS, University Hospitals of Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCV13 in SIBDCS
  • SIBDCS Project n° 2012-17 (Other Identifier: Swiss IBD Cohort Study number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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