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Completed

NCT Number: NCT04885907

Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

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.

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Key information

Conditions

Vaccine Response Impaired COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Immune Suppression Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network, Toronto General Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mRNA-1273 Vaccine

Biological

COVID vaccine 3rd dose

Other names: Moderna COVID-19 vaccine

Normal Saline Placebo

Other

Normal Saline Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events

    Time frame: 7 days after intervention

    Percentage of patient with local and systemic adverse events

  2. 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

Other outcomes

  1. SARS-CoV-2 infection

    Time frame: 6 months after intervention

    Number of patients with microbiologically proven infection

  2. Rejection

    Time frame: 4 weeks after intervention

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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