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Induction of Gut Permeability by an Oral Vaccine

NCT04083950 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

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.

DRUG

Aspirin (Positive Control)

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

Sponsors & Collaborators

  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Danielle Lemay, PhD · USDA, ARS, Western Human Nutrition Research Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2022-01-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083950 on ClinicalTrials.gov