Vaccine Response ImpairedPhase 4NCT04885907
Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients
A Phase 4 study testing mRNA-1273 vaccine in people with Vaccine Response Impaired and Immune Suppression, run by University Health Network, Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Response Impaired, Immune Suppression, Covid19
- What is being tested?
- mRNA-1273 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 25 May 2021to 30 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid organ transplant recipient who has previously received Moderna vaccine at 0 and 1 months
- Able to provide informed consent
Who cannot join
- Anaphylaxis or allergic reaction to Moderna vaccine
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, M5G2N2
About this study
Official title: A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ 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.
Read the 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
- Being tested
- mRNA-1273 vaccine, Normal Saline Placebo
- Keywords
- solid organ transplant, vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273 vaccineBiological
Also called Moderna COVID-19 vaccine
COVID vaccine 3rd dose
Normal Saline PlaceboOther
Normal Saline Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Participants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle Receives: Biological: mRNA-1273 vaccine |
| Comparator Group | Placebo comparator | Participants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle Receives: Other: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-RBD antibody titer
Percentage of patients that achieve anti-RBD of >=100 U/mL in each arm
Measured: 4-6 weeks after intervention
Secondary outcomes (2)
Adverse events
Percentage of patient with local and systemic adverse events
Measured: 7 days after intervention
T-cell response
Proportion of participants with an increase in polyfunctional T-cell response compared to pre-vaccination
Measured: 4-6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start25 May 2021
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccine Response ImpairedStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepali Kumar, University Health Network, Toronto
- Investigators
- Deepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885907
- Sponsor's protocol ID
- 21-5324.0
- Status last verified
- Jul 2022
- First submitted
- 9 May 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33378609Kumar 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.
PubMed 34807716
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT04885907
- Acronym / sponsor ID
- 21-5324.0
- Conditions
- Vaccine Response Impaired, Immune Suppression, Covid19
- Keywords
- solid organ transplant, vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Biological: mRNA-1273 vaccineParticipants will receive a one dose of mRNA-1273 vaccine 0.5mL i.m. in deltoid muscle |
| Comparator Group | Placebo comparator | Other: Normal Saline PlaceboParticipants will receive one dose of normal saline injection 0.5mL i.m. in deltoid muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Solid organ transplant recipient who has previously received Moderna vaccine at 0 and 1 months
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Anaphylaxis or allergic reaction to Moderna vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1273 vaccineAlso: Moderna COVID-19 vaccineCOVID vaccine 3rd dose | Biological | Experimental group |
| Normal Saline PlaceboNormal Saline Placebo | Other | Comparator Group |
Primary outcome
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
2 secondary outcomes
Adverse events
Time frame: 7 days after intervention
T-cell response
Time frame: 4-6 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 33378609Baden 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.
- Derived from this study: PubMed 34807716Kumar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepali Kumar, MD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mRNA-1273 vaccine in people with Vaccine Response Impaired and Immune Suppression, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-RBD antibody titer (time frame: 4-6 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.