Induction of Gut Permeability by an Oral Vaccine
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|ClinicalTrials.gov Identifier: NCT04083950|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Permeability Inflammation Vaccine Typhoid Fever||Biological: Vivotif Typhoid Oral Vaccine Drug: Aspirin (Positive Control)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Induction of Gut Permeability by an Oral Vaccine|
|Actual Study Start Date :||December 4, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Single group
All participants will receive the vaccine and aspirin.
Biological: Vivotif Typhoid Oral Vaccine
One capsule is swallowed on alternate days, e.g. days 15, 17, 19, and 21, for a total of 4 capsules.
Other Name: Ty21a Typhoid Oral Vaccine
Drug: Aspirin (Positive Control)
Three tablets (325 mg aspirin in each tablet or 975 mg total) are swallowed on days 2 and 3.
Other Name: Aspirin Challenge
- Change in intestinal permeability [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of sugar (lactulose, D-mannitol, and sucralose) excretion in urine.
- Antibody response to typhoid vaccination [ Time Frame: Day 1, 18, 22, 24, and 29 ]Measurement of Typhi-specific immunoglobulin G (IgG) and immunoglobulin A (IgA) plasma cells in peripheral blood using the antibody in lymphocyte supernatant assay.
- T-cell response to typhoid vaccination [ Time Frame: Day 1, 22, and 29 ]Measurement of vaccine-specific cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cells in peripheral blood mononuclear cells.
- Change in markers of inflammation [ Time Frame: Day 1, 3, 16, 18, 22, and 24 ]Measurement of plasma cytokines, chemokines, and acute phase proteins by a multiplex immunoassay.
- Change in intestinal fatty acid binding protein (iFABP) [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of plasma iFABP.
- Change in D-lactate [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of plasma D-lactate.
- Change in diamine oxidase [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of plasma diamine oxidase.
- Change in lipopolysaccharide binding protein (LBP) [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of plasma LBP.
- Change in citrulline [ Time Frame: Day 1, 3, 16, 18, and 22 ]Measurement of plasma citrulline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083950
|Contact: Ellen Bonnel, PhDfirstname.lastname@example.org|
|Contact: Yuriko Adkins, PhDemail@example.com|
|Principal Investigator:||Danielle Lemay, PhD||USDA, ARS, Western Human Nutrition Research Center|