M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT05239403
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pregnant women may be included in this study.
Undergo collection of blood and stool samples
Other names: Biological Sample Collection, Biospecimen Collected
Complete questionnaires
Time frame: through study completion, an average of 1 year
M.D. Anderson Cancer Center
Other
Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
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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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