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OpenTrials
Active, Not Recruiting

NCT Number: NCT05239403

Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Participants with a contraindication to the recommended annual influenza vaccine

Pregnant women may be included in this study.

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood and stool samples

Other names: Biological Sample Collection, Biospecimen Collected

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Correlation between fecal microbiome diversity and seroconversion following influenza vaccination

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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