Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

Study Overview
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Brief Summary
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This study will be a randomized, double-blind, placebo-controlled trial of a third dose of Moderna vaccine versus placebo. Participants will be those that have received two doses of mRNA-1273 COVID vaccine (Moderna) at 0 and 1 months. Participants will be randomized 1:1 to receive either a third dose of the mRNA-1273 vaccine or saline placebo at 3 months post initial vaccination.

Detailed Description
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Solid organ transplant (SOT) recipients are at high risk of COVID-19 complications. The Moderna vaccine (mRNA-1273) has proven highly efficacious and safe in a phase III large, randomized controlled trial of 30,420 persons in the general population, and has been in use in Canada since December 2020. SOT patients show diminished response to mRNA vaccines in several studies with approximately 40-50% positive antibody after the second dose. In positive patients, antibody titers are lower than the general population and adverse events mirror the general population. The current study will recruit 120 SOT recipients who have received both scheduled doses of the Moderna vaccine at 0 and 1 months. The hypothesis is that a third dose of vaccine will significantly increase antibody titers. SOT participants will be recruited and randomized 1:1 to receive an additional dose of Moderna COVID-19 vaccine two months after the last dose vs saline placebo. The outcomes will measure anti-RBD antibody titer, T-cell immunity, local/systemic side effects, and rejection events.

Official Title
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A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients

Conditions
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Immune Suppression, Covid19, Vaccine Response Impaired

Intervention / Treatment
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* Biological: mRNA-1273 vaccine
* Other: Normal Saline Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid organ transplant recipient who has previously received Moderna vaccine at 0 and 1 months Able to provide informed consent Exclusion Criteria: Anaphylaxis or allergic reaction to Moderna vaccine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, placebo-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>Participants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle | Biological: mRNA-1273 vaccine<br>* COVID vaccine 3rd dose<br>* Other names: Moderna COVID-19 vaccine;|
| Placebo Comparator: Comparator Group<br>Participants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle | Other: Normal Saline Placebo<br>* Normal Saline Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-RBD antibody titer | Percentage of patients that achieve anti-RBD of >=100 U/mL in each arm | 4-6 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Percentage of patient with local and systemic adverse events | 7 days after intervention | 
| T-cell response | Proportion of participants with an increase in polyfunctional T-cell response compared to pre-vaccination | 4-6 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid organ transplant, vaccine