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

University of Wisconsin, Madison46 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Inflammatory Bowel Diseases

Interventions

Influenza vaccineBIOLOGICAL

Observe effects of flu vaccine on microbiome

COVID-19 vaccineBIOLOGICAL

Observe effects of COVID-19 vaccine on microbiome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Influenza or COVID-19 antibody concentrations

Time frame: 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.

Time frame: 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.

Time frame: One stool collection between days 0-65

Secondary Outcomes

Correlation between Fecal Metabolomic Activity and Vaccine Response

Time frame: up to 65 days

Correlation between Saliva DNA and Vaccine Response

Data from ClinicalTrials.gov

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