Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885907
• Other study ID #: 21-5324.0
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: July 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Immune Suppression
• Vaccine Response Impaired

Intervention

Biological:
• mRNA-1273 vaccine
COVID vaccine 3rd dose

Other:
• Normal Saline Placebo
Normal Saline Placebo

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital, Multi-Organ Transplant	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SARS-CoV-2 infection	Number of patients with microbiologically proven infection	6 months after intervention
Other	Rejection	Proportion of patients with biopsy-proven or clinically treated graft rejection	4 weeks after intervention
Primary	anti-RBD antibody titer	Percentage of patients that achieve anti-RBD of >=100 U/mL in each arm	4-6 weeks after intervention
Secondary	Adverse events	Percentage of patient with local and systemic adverse events	7 days after intervention
Secondary	T-cell response	Proportion of participants with an increase in polyfunctional T-cell response compared to pre-vaccination	4-6 weeks after intervention