Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

NCT04885907 | Completed Phase 4 FDA Drug

• 1 other identifier: 21-5324.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaccine Response Impaired; Immune Suppression; Covid19

Keywords

solid organ transplant; vaccine

Outcome Measures

Primary Outcomes (1)

• anti-RBD antibody titer

  Percentage of patients that achieve anti-RBD of \>=100 U/mL in each arm

  4-6 weeks after intervention

Secondary Outcomes (2)

• Adverse events

  7 days after intervention

• T-cell response

  4-6 weeks after intervention

Other Outcomes (2)

• SARS-CoV-2 infection

  6 months after intervention

• Rejection

  4 weeks after intervention

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Biological: mRNA-1273 vaccine

Comparator Group

PLACEBO COMPARATOR

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

Other: Normal Saline Placebo

Interventions

mRNA-1273 vaccine BIOLOGICAL

COVID vaccine 3rd dose

Also known as: Moderna COVID-19 vaccine

Experimental group

Normal Saline Placebo OTHER

Normal Saline Placebo

Comparator Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solid organ transplant recipient who has previously received Moderna vaccine at 0 and 1 months
• Able to provide informed consent

You may not qualify if:

• Anaphylaxis or allergic reaction to Moderna vaccine

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

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

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (2)

• 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.

  PMID: 33378609 BACKGROUND

• 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.

  PMID: 34807716 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Deepali Kumar, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and vaccinator will be blinded to vaccine vs placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Model Details: Randomised, placebo-controlled trial

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: May 25, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)