Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

Phase 4

Completed

• Conditions: Immune Suppression; Vaccine Response Impaired; Covid19
• Interventions: Other: Normal Saline Placebo; Biological: mRNA-1273 vaccine

• Registration Number: NCT04885907
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-13
• Study Start: 2021-05-25
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Solid organ transplant recipient who has previously received Moderna vaccine at 0 and 1 months
• Able to provide informed consent

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Exclusion Criteria

• Anaphylaxis or allergic reaction to Moderna vaccine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator Group	Normal Saline Placebo	Participants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle
Experimental group	mRNA-1273 vaccine	Participants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle

Primary Outcome Measures

Name	Time	Method
anti-RBD antibody titer	4-6 weeks after intervention	Percentage of patients that achieve anti-RBD of \>=100 U/mL in each arm

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Health Network, Toronto General Hospital, Multi-Organ Transplant; 🇨🇦 Toronto, Ontario, Canada

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada