NCT05239403

Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Influenza

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and stool samples
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2021-08-24
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2022-02-14
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States