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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
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2014
Primary Completion Date : June 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01908283

University Hospitals of Geneva
Geneva, Switzerland, 1211
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)
Principal Investigator: Klara M. Posfay-Barbe, MD, MS University Hospitals of Geneva
More Information

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 ( Other Identifier: Swiss IBD Cohort Study number )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

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