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

NCT01908283 | Completed Phase 4 DMC

• 2 other identifiers: PCV13 in SIBDCSSIBDCS Project n° 2012-17
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (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.

  2 months after immunization

Secondary Outcomes (2)

• safety of PCV13 administration in patients with inflammatory bowel disease

  6 months

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

  2 months

Study Arms (2)

Patient non immunosuppressed

EXPERIMENTAL

Group 1 : patient without immunosuppressive treatment

Biological: 13-valent pneumococcal conjugated vaccine (PCV13)

Patient immunosuppressed

EXPERIMENTAL

Group 2 : patient with immunosuppressive treatment

Biological: 13-valent pneumococcal conjugated vaccine (PCV13)

Interventions

13-valent pneumococcal conjugated vaccine (PCV13) BIOLOGICAL

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

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

Patient immunosuppressed; Patient non immunosuppressed

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klara M. Pósfay Barbe: lead
• Swiss IBD Cohort Study: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33971650 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Klara M. Posfay-Barbe, MD, MS

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Klara M. Posfay-Barbe, MD, MS

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

CH (1)