Association Between Gut Microbiome and Dietary Determinants and Vaccine Response

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Influenza

Treatments: Procedure: Biospecimen Collection; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05239403

2020-1054 (Other Identifier)

NCI-2021-09308 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Observational (questionnaire, biospecimen collection)

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Biospecimen Collection