Trial NCT04885907
Publication Hall VG, N Engl J Med, 2021
Dates: 2021-05-25 to 2021-06-03
Funding: Public/non profit (The Ajmera Transplant Centre and the Di Poce Transplant Fund, University Health Network, University of Toronto)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Canada Follow-up duration (months): 1 | |
mRNA-1273 vaccine (n=60) Placebo (n=60) |
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Inclusion criteria | Adult patients aged ≥18 years; had received an organ transplant (kidney, liver, heart, lung and pancreas, or combined organs); had a functioning allograft; had already received both doses of the mRNA-1273 vaccine at the 0,1-month interval |
Exclusion criteria | Within 1-month post-transplant; had a febrile illness within 1-week prior; previous microbiologically confirmed COVID-19 infection; active cytomegalovirus (CMV) infection; received intravenous immunoglobulin in the 4 weeks prior; received rituximab in the last 6 months; had treatment for acute rejection in the 30 days prior; an allergic reaction to the previous mRNA-1273 vaccination |
Interventions | |
Intervention
A third IM booster dose of mRNA-1273 vaccine, 2 months after the second dose |
|
Control
1 IM dose of saline placebo, 2 months after the second dose of mRNA-1273 vaccine | |
Participants | |
Randomized 120 participants | |
Characteristics of participants Type of participants: Transplant recipients N=120 79 males Children: 0 Immunocompromized patients: 120 Mean age: Age range: NR | |
Description of participants Solid organ transplant recipients with no previous diagnosis of COVID-19 who has previously received two doses of mRNA-1273 at a single center in Canada | |
Primary outcome | |
In the register Anti-RBD antibody titer [ Time Frame: 4-6 weeks after intervention ]. Percentage of patients that achieve anti-RBD of >=100 U/mL in each arm | |
In the report Serologic response characterized by an anti–receptor-binding domain (RBD) antibody level of at least 100 U per milliliter at month 4 (measured with an Elecsys Anti-SARS-CoV-2 immunoassay [Roche]) | |
Variants description | |
Variants | |
Description * | |
Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, Immediately after publication to 5 years after publication |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment | In addition to the published article, the supplementary materials, study registry, and protocol were used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. |