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Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT04885907
Collaborator
(none)
120
Enrollment
2
Locations
2
Arms
3.2
Actual Duration (Months)
60
Patients Per Site
18.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1273 vaccine
  • Other: Normal Saline Placebo
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised, placebo-controlled trialRandomised, placebo-controlled trial
Masking:
Double (Participant, Care Provider)
Masking Description:
Participant and vaccinator will be blinded to vaccine vs placebo
Primary Purpose:
Prevention
Official Title:
A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients
Actual Study Start Date :
May 25, 2021
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Experimental group

Participants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle

Biological: mRNA-1273 vaccine
COVID vaccine 3rd dose
Other Names:
  • Moderna COVID-19 vaccine

    		•
    Placebo Comparator: Comparator Group

    Participants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle

    Other: Normal Saline Placebo
    Normal Saline Placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Adverse events [7 days after intervention]

      Percentage of patient with local and systemic adverse events

    2. T-cell response [4-6 weeks after intervention]

      Proportion of participants with an increase in polyfunctional T-cell response compared to pre-vaccination

    Other Outcome Measures

    1. SARS-CoV-2 infection [6 months after intervention]

      Number of patients with microbiologically proven infection

    2. Rejection [4 weeks after intervention]

      Proportion of patients with biopsy-proven or clinically treated graft rejection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network, Toronto General Hospital Toronto Ontario Canada M5G 2N2
    2 University Health Network, Toronto General Hospital, Multi-Organ Transplant Toronto Ontario Canada M5G2N2

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Deepali Kumar, MD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Deepali Kumar, Clinician-Investigator, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04885907
    Other Study ID Numbers:
    • 21-5324.0
    First Posted:
    May 13, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Deepali Kumar, Clinician-Investigator, University Health Network, Toronto
    solid organ transplant
    vaccine
    Additional relevant MeSH terms:
    COVID-19
    Vaccines

    Study Results

    No Results Posted as of Aug 2, 2022