Crohn Disease Clinical Trial
— PCV13inSIBDCSOfficial title:
Influence of Immunosuppressive Treatment on Immunological Response to Pneumococcal Conjugated Vaccine (PCV13) in Patients With Inflammatory Bowel Disease
Verified date | September 2020 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospitals of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
Klara M. Pósfay Barbe | Swiss IBD Cohort Study |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 months | |
Secondary | 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. | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 | |
Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 |