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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09308 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1054 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood and stool samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between fecal microbiome diversity and seroconversion following influenza vaccination | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants with a contraindication to the recommended annual influenza vaccine
Pregnant women may be included in this study.
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MD Anderson employees
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Wargo | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Blood, stool
| Questionnaire Administration | Other | Complete questionnaires |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |