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

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ClinicalTrials.gov Identifier: NCT01908283
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : December 30, 2016
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

July 23, 2013
July 25, 2013
December 30, 2016
March 2014
June 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01908283 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Induction of Immunity Against Streptococcus Pneumoniae in Adults With Inflammatory Bowel Disease
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)

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Colitis, Ulcerative
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 non immunosuppressed
    Group 1 : patient without immunosuppressive treatment
    Intervention: Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
  • Experimental: Patient immunosuppressed
    Group 2 : patient with immunosuppressive treatment
    Intervention: Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Same as current
December 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01908283
PCV13 in SIBDCS
SIBDCS Project n° 2012-17 ( Other Identifier: Swiss IBD Cohort Study number )
Yes
Not Provided
Not Provided
Klara M. Pósfay Barbe, University Hospital, Geneva
Klara M. Pósfay Barbe
  • Swiss IBD Cohort Study
  • Foundation for liver and gut studies (FLAGS)
  • Schweizerische Morbus Crohn / Colitis ulcerosa Vereinigung (SMCCV)
Principal Investigator: Klara M. Posfay-Barbe, MD, MS University Hospitals of Geneva
University Hospital, Geneva
December 2016

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