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Inflammatory Bowel DiseasesPhase 4PCV13inSIBDCSNCT01908283

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

A Phase 4 study testing 13-valent pneumococcal conjugated vaccine (PCV13) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Klara M. Pósfay Barbe at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
13-valent pneumococcal conjugated vaccine (PCV13)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSwitzerland
Study dates
Mar 2014to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospitals of Geneva

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: 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.

Read more

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)
Read the detailed description
  1. 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.

  1. Intervention
  2. Vaccine history evaluation: A questionnaire will be filled at baseline including questions to establish patients' history of vaccine-preventable diseases and/or immunizations.
  3. 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.
  4. Pneumococcal immunization: PCV13 (1 dose=0.5ml, intra-muscular) will be administrated during the same inclusion visit. Optional intervention (depending on available funds):
  5. 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.
  6. 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.

  1. 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.

Being tested
13-valent pneumococcal conjugated vaccine (PCV13)
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13-valent pneumococcal conjugated vaccine (PCV13)Biological

    Also called Streptococcus pneumoniae conjugated vaccine, PCV13 (Prevenar13®, Pfizer AG, Zurich), Swissmedic authorization number 60129

    Immunization with 1 dose of PCV13 (=0.5ml) intra-muscular

Study groups in NCT01908283
Study groupRoleWhat they receive
Patient non immunosuppressedExperimentalGroup 1 : patient without immunosuppressive treatment
Receives: Biological: 13-valent pneumococcal conjugated vaccine (PCV13)
Patient immunosuppressedExperimentalGroup 2 : patient with immunosuppressive treatment
Receives: Biological: 13-valent pneumococcal conjugated vaccine (PCV13)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serologic response to PCV13 vaccine in patients with inflammatory bowel disease

    Patients with inflammatory bowel disease will receive the PCV13 vaccine and a blood sample scheduled 2 months after will evaluate vaccine responses.

    Measured: 2 months after immunization

Secondary outcomes (2)

  1. safety of PCV13 administration in patients with inflammatory bowel disease

    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.

    Measured: 6 months

  2. Evaluate the relative influence of treatment and disease on immune responses to PCV13 immunization

    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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908283
Sponsor's protocol ID
PCV13 in SIBDCS
Other IDs
SIBDCS Project n° 2012-17
Acronym
PCV13inSIBDCS
Status last verified
Sep 2020
First submitted
23 Jul 2013
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Pittet LF, Verolet CM, Michetti P, Gaillard E, Girardin M, Juillerat P, Mottet C, Maillard MH, Siegrist CA, Posfay-Barbe KM; Swiss Inflammatory Bowel Disease Cohort Study Group. Risk of Vaccine-Preventable Infections in Swiss Adults with Inflammatory Bowel Disease. Digestion. 2021;102(6):956-964. doi: 10.1159/000516111. Epub 2021 May 10.

    PubMed 33971650

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 13-valent pneumococcal conjugated vaccine (PCV13) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Klara M. Pósfay Barbe at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serologic response to PCV13 vaccine in patients with inflammatory bowel disease (time frame: 2 months after immunization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01908283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

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