Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

NCT ID: NCT04885907

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2021-08-30

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.

Conditions

Vaccine Response Impaired; Immune Suppression; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

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

Group Type: ACTIVE_COMPARATOR

mRNA-1273 vaccine

Intervention Type: BIOLOGICAL

COVID vaccine 3rd dose

Comparator Group

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

Group Type: PLACEBO_COMPARATOR

Normal Saline Placebo

Intervention Type: OTHER

Normal Saline Placebo

Interventions

mRNA-1273 vaccine

COVID vaccine 3rd dose

Intervention Type: BIOLOGICAL

Normal Saline Placebo

Normal Saline Placebo

Intervention Type: OTHER

Other Intervention Names

Moderna COVID-19 vaccine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Deepali Kumar

Clinician-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 33378609 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34807716 (View on PubMed)

Other Identifiers

21-5324.0

Identifier Type: -

Identifier Source: org_study_id