Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT04885907

Recruitment Status : Completed

First Posted : May 13, 2021

Last Update Posted : August 2, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Deepali Kumar, University Health Network, Toronto

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
Vaccine Response Impaired Immune Suppression Covid19	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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
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
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 :	July 30, 2021
Actual Study Completion Date :	August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) COVID-19 Vaccines Vaccines

U.S. FDA Resources

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 Name: 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 :

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 Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885907

Locations

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Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, Canada, M5G2N2

Sponsors and Collaborators

University Health Network, Toronto

Investigators

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

More Information

Publications:

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kumar D, Ferreira VH, Hall VG, Hu Q, Samson R, Ku T, Ierullo M, Majchrzak-Kita B, Tomlinson G, Gingras AC, Humar A. Neutralization of SARS-CoV-2 Variants in Transplant Recipients After Two and Three Doses of mRNA-1273 Vaccine : Secondary Analysis of a Randomized Trial. Ann Intern Med. 2022 Feb;175(2):226-233. doi: 10.7326/M21-3480. Epub 2021 Nov 23.

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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 Key Record Dates
Last Update Posted:	August 2, 2022
Last Verified:	July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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, University Health Network, Toronto:


solid organ transplant vaccine

Additional relevant MeSH terms:

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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

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