Induction of Gut Permeability by an Oral Vaccine

NCT04083950 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: FL109
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.

Conditions

Intestinal Permeability; Inflammation; Vaccine; Typhoid Fever

Keywords

Gastrointestinal Health; Intestinal Permeability; Inflammation; Vaccine Response; Ty21a Typhoid Vaccine; Typhoid Fever

Outcome Measures

Primary Outcomes (1)

• Change in intestinal permeability

  Measurement of sugar (lactulose, D-mannitol, and sucralose) excretion in urine.

  Day 1, 3, 16, 18, and 22

Secondary Outcomes (8)

• Antibody response to typhoid vaccination

  Day 1, 18, 22, 24, and 29

• T-cell response to typhoid vaccination

  Day 1, 22, and 29

• Change in markers of inflammation

  Day 1, 3, 16, 18, 22, and 24

• Change in intestinal fatty acid binding protein (iFABP)

  Day 1, 3, 16, 18, and 22

• Change in D-lactate

  Day 1, 3, 16, 18, and 22

Study Arms (1)

Single group

EXPERIMENTAL

All participants will receive the vaccine and aspirin.

Biological: Vivotif Typhoid Oral Vaccine; Drug: Aspirin (Positive Control)

Interventions

Vivotif Typhoid Oral Vaccine BIOLOGICAL

One capsule is swallowed on alternate days, e.g. days 15, 17, 19, and 21, for a total of 4 capsules.

Also known as: Ty21a Typhoid Oral Vaccine

Single group

Aspirin (Positive Control) DRUG

Three tablets (325 mg aspirin in each tablet or 975 mg total) are swallowed on days 2 and 3.

Also known as: Aspirin Challenge

Single group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) 18.5 - 29.9 kg/m2

You may not qualify if:

• Has HIV/AIDS or another disease that affects the immune system
• Has any kind of cancer
• Decline to take an HIV blood test
• Blood pressure greater than or equal to 140/90 mmhg
• Pregnant or lactating women
• Refusal to take a pregnancy test prior to the study
• Refusal to use a method of birth control during the study
• Allergy to vaccine components, i.e. Thimerosal and enteric-coated capsules
• Allergy to oral typhoid vaccine
• Allergy to aspirin
• Daily use of blood thinners
• Use of anti-inflammatory medications, i.e. nonsteroidal anti-inflammatory drugs (NSAID), aspirin, 3 or more times per month
• Use of sulfonamides or antibiotics in the past 30 days
• Use of anti-hypertensive drugs, i.e. beta blockers, diuretics, calcium channel blockers
• Use of anti-malaria drugs, i.e. Mefloquine, chloroquine, and proguanil

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Inflammation; Typhoid Fever

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Danielle Lemay, PhD

  USDA, ARS, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: December 4, 2019
• Primary Completion: January 31, 2022
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)