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Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT04885907
Recruitment Status : Active, not recruiting
First Posted : May 13, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 9, 2021
First Posted Date  ICMJE May 13, 2021
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE May 25, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2021)
  • Adverse events [ Time Frame: 7 days after intervention ]
    Percentage of patient with local and systemic adverse events
  • T-cell response [ Time Frame: 4-6 weeks after intervention ]
    Proportion of participants with an increase in polyfunctional T-cell response compared to pre-vaccination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2021)
  • SARS-CoV-2 infection [ Time Frame: 6 months after intervention ]
    Number of patients with microbiologically proven infection
  • Rejection [ Time Frame: 4 weeks after intervention ]
    Proportion of patients with biopsy-proven or clinically treated graft rejection
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients
Official Title  ICMJE A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, placebo-controlled trial
Masking: Double (Participant, Care Provider)
Masking Description:
Participant and vaccinator will be blinded to vaccine vs placebo
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccine Response Impaired
  • Immune Suppression
  • Covid19
Intervention  ICMJE
  • Biological: mRNA-1273 vaccine
    COVID vaccine 3rd dose
    Other Name: Moderna COVID-19 vaccine
  • Other: Normal Saline Placebo
    Normal Saline Placebo
Study Arms  ICMJE
  • Active Comparator: Experimental group
    Participants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle
    Intervention: Biological: mRNA-1273 vaccine
  • Placebo Comparator: Comparator Group
    Participants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle
    Intervention: Other: Normal Saline Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 9, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04885907
Other Study ID Numbers  ICMJE 21-5324.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deepali Kumar, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP