Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

Study Overview
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Brief Summary
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This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response. SECONDARY OBJECTIVE: I. To determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers. EXPLORATORY OBJECTIVES: I. Interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts). II. Identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response. OUTLINE: Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.

Official Title
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Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response

Conditions
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Influenza

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MD Anderson employees and student employees with existing MRN Must be able to donate blood Participants must be age 18 or older Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws Exclusion Criteria: 1. Participants with a contraindication to the recommended annual influenza vaccine Pregnant women may be included in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, biospecimen collection)<br>Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and stool samples<br>* Other names: Biospecimen Collected;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between fecal microbiome diversity and seroconversion following influenza vaccination |  | through study completion, an average of 1 year |