Phase 2
N=81
COVID-19 Protection After Transplant Pilot Study
Kidney Transplant Recipients
Bottom Line
View on ClinicalTrials.gov: NCT04969263 ↗Enrolled (actual)
81
Serious AEs
14.8%
Results posted
Jan 2024
Primary outcome: Primary: Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine — 69.1 Percentage of participants with response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BNT162b2 vaccine (Pfizer/BioNTech) (Biological); mRNA-1273 vaccine (Moderna) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine |
69.1 | — |
| SECONDARY Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine |
50.6; 45.7; 27.2; 1.23 | — |
| SECONDARY Frequency of/Proportion of Participants With Any Serious Adverse Events (SAEs) Following the Third Dose of an mRNA Vaccine |
1.23 | — |
| SECONDARY Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection (Clinical or Biopsy Proven) |
— | — |
| SECONDARY Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody |
— | — |
| SECONDARY Proportion of Participants With Graft Loss |
— | — |
| SECONDARY Occurrence of Death Among Participants |
— | — |
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-
- Able to understand and provide informed consent;
- Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment;
- 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 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-
- 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;
- Known history of severe allergic reaction to any component of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine;
- Thrombotic events, myocarditis, or pericarditis temporally associated with prior dose of COVID-19 vaccine;
- Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months;
- Significant graft dysfunction;
- Receipt of any cellular depleting agent (e.g. ATG, Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment;
- Receiving systemic immunomodulatory medication(s) for any condition other than transplant;
- Any untreated active infection, including BK viremia >10^4 copies;
- Infection with human immunodeficiency virus (HIV);
- Maintenance immunosuppressive regimen that includes belatacept or abatacept;
- Recent (within one year) or ongoing treatment for malignancy; or
- 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.
Data sourced from ClinicalTrials.gov (NCT04969263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.