Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D

Exclusion Criteria

• •1. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
• •2. History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
• •3. History of immunodeficiency
• •4. Recent (within 3 months) serious bacterial, viral, fungal, or other infections
• •5. Pending or positive SARS-CoV-2 test or symptoms of possible COVID-19 illness at baseline treatment visit.
• •6. Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
• •7. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
• •8. Active infection with EBV as defined by real-time polymerase chain reaction (PCR).
• •9. Active infection with CMV as defined by real-time PCR.
• •10. Clinically significant liver function abnormalities as defined by ALT or AST\> 1.5 x the upper limit of age-determined normal (ULN).
• •11. Any of the following hematologic abnormalities:
• •* White blood count \<3,000/μL or \>14,000/μL
• •* Lymphocyte count \<800/μL
• •* Platelet count \<75,000 /μL
• •* Hemoglobin \<10.0 g/dL
• •* Neutrophil count \<1500 cells/μL
• •12. Females who are pregnant or lactating.
• •13. Receipt of live vaccine (e.g., varicella, MMR (measles, mumps and rubella), intranasal influenza vaccine) within 6 weeks of randomization.
• •14. Receipt of other vaccines within 3 weeks of baseline treatment.
• •15. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before screening visit.
• •16. Use of non-insulin therapies aimed to control hyperglycemia within 30 days of screening visit.
• •17. History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac disease and stable thyroid disease.
• •18. Use of medications known to influence glucose tolerance. Topical, nasal, inhaled corticosteroids acceptable per investigator discretion.
• •19. Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.