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NCT05239403 | RECRUITING | Influenza

Association Between Gut Microbiome and Dietary Determinants and Vaccine Response
Sponsor:

M.D. Anderson Cancer Center

Brief Summary:

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.

Condition or disease

Influenza

Intervention/treatment

Biospecimen Collection

Questionnaire Administration

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
Actual Study Start Date : 2021-08-24
Estimated Primary Completion Date : 2025-02-28
Estimated Study Completion Date : 2025-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. MD Anderson employees and student employees with existing MRN
  • 2. Must be able to donate blood
  • 3. Participants must be age 18 or older
  • 4. Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health
  • 5. 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.
Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

Location Details

NCT05239403

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030