None listed
Conditions
Brief summary
The study will enroll 140 kidney transplant recipients eligible for the study. All participants will have previously (winter and spring 2021) received a complete standard 2-dose vaccination schedule from Pfizer/BioNTech (or Moderna). Once enrolled in the study, participants will undergo a two-step randomization process, each step forming two subgroups in 1:1 ratio, with the use of random block sizes of 4. The first step of randomization determines whether the patient receives 1 or 2 booster doses (i.e., a total of 3 or 4 doses of vaccine 4 weeks apart of either BNT162b2 and mRNA-1273 vaccines), and the second step will determine which mRNA vaccine (either mRNA-1273, Moderna or BNT162b2, Pfizer/BioNTech) will be used (for 1 or both booster doses, respectively). The transplant nephrologist will be responsible for the randomization process. Sealed, sequentially numbered envelopes will be used to conceal the allocation to groups. The study will not be further masked. Immune response to vaccination will be measured at the baseline and 1 month after booster dose administration. Humoral response will be evaluated by measurement of SARS-CoV-2 specific IgG antibody titer. COVID19-specific cellular response will be investigated using an IFN-? ELISPOT performed on cryopreserved peripheral blood mononuclear cells using SARS-CoV-2 peptide pool as a stimulator. Alongside, relevant clinical data - especially adverse events attributable to vaccination, clinical efficacy of booster vaccination (occurrence of SARS-CoV-2 infection and its severity) – will be collected prospectively. A comparison of baseline and post-booster-dose COVID19-specific cellular and humoral response will be performed.
Interventions
The participants undergo a two-step randomization process, each step forming two subgroups in 1:1 ratio, with the use of random block sizes of 4. The first step of randomization determines whether the patient receives 1 or 2 COVID19 vaccine booster doses (i.e., a total of 3 or 4 doses of vaccine 4 weeks apart of either BNT162b2 and mRNA-1273 vaccines), and the second step will determine which mRNA vaccine (either mRNA-1273, Moderna or BNT162b2, Pfizer/BioNTech) will be used (for 1 or both boost
The participants undergo a two-step randomization process, each step forming two subgroups in 1:1 ratio, with the use of random block sizes of 4. The first step of randomization determines whether the patient receives 1 or 2 COVID19 vaccine booster doses (i.e., a total of 3 or 4 doses of vaccine 4 weeks apart of either BNT162b2 and mRNA-1273 vaccines), and the second step will determine which mRNA vaccine (either mRNA-1273, Moderna or BNT162b2, Pfizer/BioNTech) will be used (for 1 or both booster doses, respectively). The vaccines were administered via intramuscular injection at transplant centre outpatient clinic. All patients attended a check-up visit a month after intervention to assess and monitor adverse events and effectivity of the intervention (see also later).
Sponsors
Martin Kacer
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult (>18 years with no upper age limit) renal transplant (deceased or living donor) recipients, male or female. - SARS-CoV-2 naive prior standard 2-dose vaccination and before booster doses - Completed standard vaccination schedule with BNT162b2, Pfizer/BioNTech - SARS-CoV-2 specific IgG antibody titer < 10 arbitrary units per milliliter (AU/mL) - Ability to sign informed consent.
Exclusion criteria
- Confirmed active (RT-PCR) SARS-CoV-2 infection throughout the study - Known previous SARS-CoV-2 infection - SARS-CoV-2 specific IgG antibody titer greatrer than 10 arbitrary units per milliliter (AU/mL) upon enrollment - Inability to complete full booster vaccination schedule (allergy, infection, etc.). - Signs of active infection in baseline - Inability to sign informed consent.
Outcome results
None listed