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Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05239403
Collaborator
National Cancer Institute (NCI) (NIH)
1,000
Enrollment
1
Location
42.2
Anticipated Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response.
SECONDARY OBJECTIVE:
  1. 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:

  1. Interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts).

  2. 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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
Actual Study Start Date :
Aug 24, 2021
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
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
Undergo collection of blood and stool samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

    • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between fecal microbiome diversity and seroconversion following influenza vaccination [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. MD Anderson employees and student employees

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jennifer Wargo, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05239403
    Other Study ID Numbers:
    • 2020-1054
    • NCI-2021-09308
    • 2020-1054
    First Posted:
    Feb 14, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 30, 2022