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.
This is an open label, non-randomized study in kidney transplant recipients who received two doses of either mRNA COVID-19 vaccine and have a negative (\<0.8 U/mL) or low (titer \<50 U/mL) SARS-CoV-2 antibody response using the Roche Elecsys® anti-RBD assay. Eligible participants will receive a third dose of the same mRNA vaccine as the prior two doses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
81
30 microgram dose
100 microgram dose
Johns Hopkins Hospital
Baltimore, Maryland, United States
Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine
The proportion of participants who achieve an antibody response \>50 U/mL after the third dose of vaccine using the Roche Elecsys® anti-RBD assay is considered to show positive response to the intervention, negative response otherwise.
Time frame: Outcome was measured at 30 days after study intervention (dose 3 vaccination)
Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine
Safety measure status post third dose of mRNA vaccine
Time frame: Through Day 7 Post-Vaccination (Dose 3)
Frequency of/Proportion of Participants With Any Serious Adverse Events (SAEs) Following the Third Dose of an mRNA Vaccine
Safety measure status post third dose of mRNA vaccine
Time frame: Through Day 30 Post-Vaccination (Dose 3)
Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection (Clinical or Biopsy Proven)
Safety measure status post third dose of mRNA vaccine
Time frame: Through Day 60 Post-Vaccination (Dose 3)
Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody
Safety measure status post third dose of mRNA vaccine
Time frame: Through Day 90 Post-Vaccination (Dose 3)
Proportion of Participants With Graft Loss
Safety measure status post third dose of mRNA vaccine.
Time frame: Through Day 60 Post-Vaccination (Dose 3)
Occurrence of Death Among Participants
Safety measure status post third dose of mRNA vaccine.
Time frame: Through Day 60 Post-Vaccination (Dose 3)
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