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)
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])
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes, Immediately after publication to 5 years after publication
Data accessibility: Data can be obtained by contacting the investigators at Deepali.kumar@uhn.ca
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.