Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

NCT05239403 | Active Not Recruiting

• 2 other identifiers: 2020-1054NCI-2021-09308
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Correlation between fecal microbiome diversity and seroconversion following influenza vaccination

  through study completion, an average of 1 year

Study Arms (1)

Observational (questionnaire, biospecimen collection)

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; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and stool samples

Also known as: Biological Sample Collection, Biospecimen Collected

Observational (questionnaire, biospecimen collection)

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaire, biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson employees

You may qualify if:

• 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

You may not qualify if:

• \. Participants with a contraindication to the recommended annual influenza vaccine
• Pregnant women may be included in this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jennifer Wargo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: August 24, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)