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

NCT05584735 | Completed FDA Drug

• 4 other identifiers: 2021-0977A534250SMPH/MEDICINE/GASTROENTProtocol version 7/18/2024
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's disease; ulcerative colitis

Outcome Measures

Primary Outcomes (4)

• Influenza or COVID-17 antibody concentrations

  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.

  Baseline

• Influenza or COVID-19 antibody concentrations

  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.

  One blood draw between 28-65 days after baseline

• Microbiome metrics

  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.

  One stool collection between days 0-65

• Microbiome stability

  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.

  One stool collection between days 0-65

Secondary Outcomes (2)

• Correlation between Fecal Metabolomic Activity and Vaccine Response

  up to 65 days

• Correlation between Saliva DNA and Vaccine Response

  up to 65 days

Study Arms (1)

Participants with Inflammatory Bowel Disease (IBD)

Participants with IBD who are receiving a flu or COVID-19 vaccine

Biological: Influenza vaccine; Biological: COVID-19 vaccine

Interventions

Influenza vaccine BIOLOGICAL

Observe effects of flu vaccine on microbiome

Participants with Inflammatory Bowel Disease (IBD)

COVID-19 vaccine BIOLOGICAL

Observe effects of COVID-19 vaccine on microbiome

Participants with Inflammatory Bowel Disease (IBD)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with IBD

You may qualify if:

• 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:
• 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
• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Saliva, and Fecal samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Influenza Vaccines; COVID-19 Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Freddy Caldera, DO, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: November 3, 2023
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)