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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Geneva
Sponsor:
Collaborators:
Swiss IBD Cohort Study
Foundation for liver and gut studies (FLAGS)
Schweizerische Morbus Crohn / Colitis ulcerosa Vereinigung (SMCCV)
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01908283
First received: July 23, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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)

Condition Intervention Phase
Inflammatory Bowel Diseases
Crohn Disease
Colitis, Ulcerative
Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of Immunosuppressive Treatment on Immunological Response to Pneumococcal Conjugated Vaccine (PCV13) in Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • serologic response to PCV13 vaccine in patients with inflammatory bowel disease [ Time Frame: 2 months after immunization ] [ Designated as safety issue: Yes ]
    Patients with inflammatory bowel disease will receive the PCV13 vaccine and a blood sample scheduled 2 months after will evaluate vaccine responses.


Secondary Outcome Measures:
  • safety of PCV13 administration in patients with inflammatory bowel disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Evaluate the relative influence of treatment and disease on immune responses to PCV13 immunization [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: April 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908283

Contacts
Contact: Klara M. Posfay-Barbe, MD, MS +41 22 372 5462 Klara.PosfayBarbe@hcuge.ch
Contact: Charlotte F Verolet +41223725481 charlotte.verolet@hcuge.ch

Locations
Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Klara M. Posfay-Barbe, MD, MS    +41 22 372 5462    Klara.PosfayBarbe@hcuge.ch   
Principal Investigator: Klara M Posfay-Barbe, MD, MS         
Sub-Investigator: Marc Girardin, MD         
Sub-Investigator: Claire-Anne Siegrist, MD         
Sub-Investigator: Laure F. Pittet, MD         
Sub-Investigator: Charlotte Verolet, MD         
Sponsors and Collaborators
Klara M. Pósfay Barbe
Swiss IBD Cohort Study
Foundation for liver and gut studies (FLAGS)
Schweizerische Morbus Crohn / Colitis ulcerosa Vereinigung (SMCCV)
Investigators
Principal Investigator: Klara M. Posfay-Barbe, MD, MS University Hospitals of Geneva
  More Information

No publications provided

Responsible Party: Klara M. Pósfay Barbe, Klara M. Posfay-Barbe, MD, MS, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01908283     History of Changes
Other Study ID Numbers: PCV13 in SIBDCS, SIBDCS Project n° 2012-17
Study First Received: July 23, 2013
Last Updated: June 24, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014