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Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine

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ClinicalTrials.gov Identifier: NCT05584735
Recruitment Status : Recruiting
First Posted : October 18, 2022
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Biological: Influenza vaccine Biological: COVID-19 vaccine

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
Actual Study Start Date : November 3, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants with Inflammatory Bowel Disease (IBD)
Participants with IBD who are receiving a flu or COVID-19 vaccine
 Biological: Influenza vaccine
Observe effects of flu vaccine on microbiome

Biological: COVID-19 vaccine
Observe effects of COVID-19 vaccine on microbiome


Outcome Measures
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Primary Outcome Measures :
  1. Influenza or COVID-17 antibody concentrations [ Time Frame: Baseline ]
    Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.

  2. Influenza or COVID-19 antibody concentrations [ Time Frame: One blood draw between 28-65 days after baseline ]
    Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.

  3. Microbiome metrics [ Time Frame: One stool collection between days 0-65 ]
    Microbiome metrics will include phylogenetic diversity, and analyses of relative abundance of microbes using 16SrRNA gene sequence data from fecal material. Alpha diversity of the microbiome will be evaluated.

  4. Microbiome stability [ Time Frame: One stool collection between days 0-65 ]
    Microbiome stability will be evaluated using hierarchical clustering of weighted and unweighted UniFrac distances (a beta diversity metric indexing compositional similarity/difference) for microbiome using 16SrRNA gene sequence data from fecal material.


Secondary Outcome Measures :
  1. Correlation between Fecal Metabolomic Activity and Vaccine Response [ Time Frame: up to 65 days ]
  2. Correlation between Saliva DNA and Vaccine Response [ Time Frame: up to 65 days ]

Biospecimen Retention:   Samples With DNA
Blood, Saliva, and Fecal samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with IBD
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 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)

    2. Group B: Non-TNG biologic -

      • Ustekinumab on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
      • Vedolizumab Therapy Group: Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine
      • Risankizumab Therapy: 360mg every 8 weeks

    3. Group C: Janus Kinase Therapy

      • Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
      • Upadactinib Therapy Group: on upadactinib at least 15mg PO
  • 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 antibiotics within previous 2 months
Contacts and Locations
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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): NCT05584735


Contacts
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Contact: Marie Najdowski 608-262-0162 mnajdowski@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Freddy Caldera, DO, MS University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05584735    
Other Study ID Numbers: 2021-0977
A534250 ( Other Identifier: UW Madison )
SMPH/MEDICINE/GASTROENT ( Other Identifier: UW Madison )
Protocol version 7/19/2023 ( Other Identifier: UW Madison )
First Posted: October 18, 2022    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Wisconsin, Madison:
Crohn's disease
ulcerative colitis
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Gastroenteritis
Vaccines
Immunologic Factors
Physiological Effects of Drugs