Induction of Gut Permeability by an Oral Vaccine

Learn more about:
Related Clinical Trial
Transcriptomic Responses for the Identification of Pathogens Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants Commercial Typhoid Tests Validation Trial Commercial Typhoid Tests Validation WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Safety and Immunogenicity of Typhax, a Typhoid Vaccine Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Investigating Enteric Fever – Salmonella Typhi and Paratyphi Challenge Study Induction of Gut Permeability by an Oral Vaccine Studies of Immune Responses to Orally Administered Vaccines in Developing Country Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants Typhoid Fever: Combined vs. Single Antibiotic Therapy Vaccines Against Salmonella Typhi Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults CVD 909 Vi Prime Boost Study Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Understanding Typhoid Disease After Vaccination Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

Brief Title

Induction of Gut Permeability by an Oral Vaccine

Official Title

Induction of Gut Permeability by an Oral Vaccine

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.
    

Detailed Description

      The licensed Ty21a vaccine strain of S. enterica Typhi is routinely used by travelers to
      countries where typhoid is common. It is not known whether the vaccine causes measurable
      changes in intestinal permeability and whether changes in permeability are correlated with
      the magnitude of the vaccine response. In the current study, gut permeability will be
      measured in participants at baseline and after an aspirin challenge, which is known to
      disrupt intestinal permeability, and after the first, second, and fourth doses of a the Ty21a
      vaccine. Intestinal permeability will be measured using a three-sugar absorption test
      composed of lactulose, mannitol, and sucralose and by several plasma markers. Vaccine
      response will be measured by quantitating T cells and newly developed IgG-or IgA-secreting
      plasma cells specific for Ty21a.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in intestinal permeability

Secondary Outcome

 Antibody response to typhoid vaccination

Condition

Intestinal Permeability

Intervention

Vivotif Typhoid Oral Vaccine

Study Arms / Comparison Groups

 Single group
Description:  All participants will receive the vaccine and aspirin.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

15

Start Date

December 4, 2019

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility 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
      

Gender

Female

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Danielle Lemay, PhD, 530-752-4184, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04083950

Organization ID

FL109


Responsible Party

Sponsor

Study Sponsor

USDA, Western Human Nutrition Research Center


Study Sponsor

Danielle Lemay, PhD, Principal Investigator, USDA, ARS, Western Human Nutrition Research Center


Verification Date

July 2020