Clinical trial NCT05584735: Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
Official title: Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn's disease
ulcerative colitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with IBD

Brief summary: This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.

Detailed description: The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines.

It is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine.

In this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.

Eligibility criteria: Inclusion Criteria:

* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria
* Currently one of the following groups:

  1. Group A: Anti-TNF Therapy Group

     * Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
     * Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
  2. Group B: Non-TNG biologic

     * Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
     * Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
     * Risankizumab Therapy: 360mg at least every 8 weeks
  3. Group C: Janus Kinase Therapy

     * Tofacitinib Therapy: at least 5mg PO BID
     * Upadactinib Therapy: at least 15mg PO daily
* Patient has been on stable treatment for IBD for at least three months
* Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.

Exclusion Criteria:

* Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
* Recent oral antibiotics within previous 2 months

Primary outcomes:
measure: Influenza or COVID-17 antibody concentrations
timeFrame: Baseline
measure: Influenza or COVID-19 antibody concentrations
timeFrame: One blood draw between 28-65 days after baseline
measure: Microbiome metrics
timeFrame: One stool collection between days 0-65
measure: Microbiome stability
timeFrame: One stool collection between days 0-65
Secondary outcomes:
measure: Correlation between Fecal Metabolomic Activity and Vaccine Response
timeFrame: up to 65 days
measure: Correlation between Saliva DNA and Vaccine Response
timeFrame: up to 65 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Freddy Caldera, DO, MS
role: PRINCIPAL_INVESTIGATOR
References: