COVID-19 Protection After Transplant Pilot Study
Condition: Kidney Transplant Recipients
MeSH terms: COVID-19
Intervention: mRNA-1273 vaccine (Pfizer/BioNTech); mRNA-1273 vaccine (Moderna)
Intervention description: 30 microgram dose; 100 microgram dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, non-randomized.
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19 vaccine; SARS-CoV-2 antibody response

Summary:

      Antibodies are an important part of the body's defense against infection. Individuals who
      have no antibodies or very low antibody levels are considered less well protected from
      Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of
      antibodies is necessary for protection is currently unknown.

      Inadequate antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
      vaccination has been described among kidney transplant recipients. The aim of this study is
      to elicit an antibody response to vaccination against SARS-CoV-2 in kidney transplant
      recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or
      Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals who meet all the following criteria are eligible for enrollment as study
        participants-

          1. Able to understand and provide informed consent;

          2. Recipient of kidney transplant ≥12 months prior to enrollment, without treated
             allograft rejection in the 6 months preceding enrollment;

          3. Received 2 doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19
             vaccine as specified in the respective Food and Drug Administration Emergency Use
             Authorization (FDA EUAs), >30 days and <8 months prior to enrollment ; and,

          4. Negative (antibody titer < 0.8U/mL) or low (antibodies detected at titer ≤ 50 U/mL)
             response to the vaccine at > 30 days from dose 2 of the Moderna COVID-19 vaccine or
             the Pfizer BioNTech vaccine, using the Roche Elecsys® anti-Receptor Binding Domain
             (RBD) assay.

        Exclusion Criteria:

        Individuals who meet any of these criteria are not eligible for enrollment as study
        participants-

          1. Recipient of any number of doses of any COVID vaccine product other than the Moderna
             COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine;

          2. Known history of severe allergic reaction to any component of either the Moderna
             COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine;

          3. Thrombotic events, myocarditis, or pericarditis temporally associated with prior dose
             of COVID-19 vaccine;

          4. Any change in transplant immunosuppression regimen (drug or dose) in response to
             suspected or proven rejection within the last 6 months;

          5. Significant graft dysfunction;

          6. Receipt of any cellular depleting agent (e.g. ATG, Rituximab, Alemtuzumab,
             Cyclophosphamide) within 12 months preceding enrollment;

          7. Receiving systemic immunomodulatory medication(s) for any condition other than
             transplant;

          8. Any untreated active infection, including BK viremia >10^4 copies;

          9. Infection with human immunodeficiency virus (HIV);

         10. Maintenance immunosuppressive regimen that includes belatacept or abatacept;

         11. Recent (within one year) or ongoing treatment for malignancy; or

         12. Any past or current medical problems, treatments, or findings which, in the opinion of
             the investigator, may pose additional risks from participation in the study, may
             interfere with the candidate's ability to comply with study requirements or may impact
             the quality or interpretation of the data obtained from the study.