Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05239403
Enrollment
74
Registered
2022-02-14
Start date
2021-08-24
Completion date
2027-02-28
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood and stool samples

OTHERQuestionnaire Administration

Complete questionnaires

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Correlation between fecal microbiome diversity and seroconversion following influenza vaccinationthrough study completion, an average of 1 year

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Wargo

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026