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| ID | Type | Description | Link |
|---|---|---|---|
| A534250 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/GASTROENT | Other Identifier | UW Madison | |
| Protocol version 7/18/2024 | Other Identifier | UW Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Inflammatory Bowel Disease (IBD) | Participants with IBD who are receiving a flu or COVID-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Observe effects of flu vaccine on microbiome |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Fecal Metabolomic Activity and Vaccine Response | up to 65 days | |
| Correlation between Saliva DNA and Vaccine Response | up to 65 days |
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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:
Group A: Anti-TNF Therapy Group
Group B: Non-TNG biologic
Group C: Janus Kinase Therapy
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:
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Participants diagnosed with IBD
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Caldera, DO, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Blood, Saliva, and Fecal samples
| COVID-19 vaccine | Biological | Observe effects of COVID-19 vaccine on microbiome |
|
| D003092 | Colitis |
| D003108 | Colonic Diseases |