Induction of Gut Permeability by an Oral Vaccine

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: USDA, Western Human Nutrition Research Center
• Treatments: Aspirin; Vaccines

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• Use of drugs that affect the immune system, i.e. immunosuppressants, immune-modifying drugs, corticosteroids, i.e. cortisone, prednisone, methylprednisolone, for 2 weeks or longer

• Is taking cancer treatment with radiation or drugs

• Greater than ten years residence in a typhoid-endemic area

• Receipt of typhoid vaccine in the last 5 years

• Receipt of any vaccine two weeks prior to receipt of Ty21a vaccine

• Individuals at increased risk of developing complications from a live, bacterial vaccine

• History of typhoid fever

• History of primary immune deficiency or autoimmune disease

• History of acute or chronic gastrointestinal (GI) disorder, i.e. Crohn's disease, irritable bowel syndrome, gastric ulcer

• Diarrheal illness (defined as passing 3 or more abnormally loose or watery stool in a 24 hour period) or persistent vomiting 2 weeks prior to the study

• History of bleeding disorder, including bleeding from the GI tract

• History of chronic illnesses, i.e. diabetes, cardiovascular disease, cancer, gastrointestinal malabsorption or inflammatory diseases, kidney disease, autoimmune disorders, HIV, liver disease, including hepatitis B and C.

• Asthma if taking medication on a daily basis

• Recent surgery (within 3 months)

• History of GI surgery

• Recent hospitalization (within 3 months)

• Acute febrile illness (within 2 weeks)

• Unwillingness to discontinue consumption of artificial sweeteners in foods or drinks, i.e. sport drinks, coconut water, "diet" drinks and foods (possibly containing sucralose)

• Not having at least one arm vein suitable for blood drawing

• Unwilling or uncomfortable with blood draws seven times in 29 days

• Regular blood or blood product donation and refusal to suspend donation

• Current participation in another research study

• Unable to fast for 12-16 hours