High-Dose Moderna mRNA-1273 Booster Study for Lung Transplant Recipients
NCT ID: NCT05280158
Last Updated: 2025-03-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
19 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-10
Study Completion Date
2023-02-27
Brief Summary
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Lung transplant recipients have poor outcomes after COVID-19 infection with mortality. Due to the immunosuppression, they have had poor responses to SARS-CoV-2 vaccine and remain at high risk of poor outcomes. This is a Phase I/II clinical trial to evaluate the safety and immune response from a higher dose mRNA-1273 vaccine among lung transplant recipients who have already received three or four doses of the COVID-19 vaccine.
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Detailed Description
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This is a Phase I/II open-label dose-finding trial among lung transplant recipients who received three or four mRNA vaccine doses (mRNA-1273 or BNT162b2) after lung transplantation to: standard-dose (50 ug), mid-dose (100 ug) or high-dose (200 ug) mRNA-1273 booster vaccine. Sixty participants will be enrolled into three dose groups: 1) Standard-dose - 20 participants, 2) Mid-dose - 20 participants, 3) High-dose - 20 participants. The first 2 participants in both the mid-dose and high dose groups will be considered the 'sentinel' group. Participants in the sentinel group will receive the vaccine and undergo a 7-day observation period for safety and reactogenicity before additional participants are enrolled into that dose group.
Overall study enrollment will begin with the mid-dose sentinel group (n=2). During the observation period for the mid-dose sentinel group, we will enroll two participants into the standard-dose group. Once the mid-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 1) with a 2:1 randomization into the mid-dose (n=18) and standard-dose (n=9) groups.
Once all 20 participants have received their mid-dose vaccine without triggering halting rules and is approved to proceed by the DSMB, we will enroll the high-dose sentinel group (n=2). Once the high-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 2) with a 2:1 randomization into the high-dose (n=18) and standard-dose (n=9) groups. All 20 participants in the mid-dose group will be enrolled prior to the enrollment of the high-dose group.
We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines. Randomization with be done by the UCLA Clinical and Translational Science Institute (CTSI) statistics team based on scheduled participants prior to the study visit. The 6 participants in the sentinel (n=4) and initial (n=2) groups (Table 1) will be assigned into the 3 groups based on their scheduled visit day.
Overall study enrollment will begin with the mid-dose sentinel group (n=2). During the observation period for the mid-dose sentinel group, we will enroll two participants into the standard-dose group. Once the mid-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 1) with a 2:1 randomization into the mid-dose (n=18) and standard-dose (n=9) groups.
Once all 20 participants have received their mid-dose vaccine without triggering halting rules and is approved to proceed by the DSMB, we will enroll the high-dose sentinel group (n=2). Once the high-dose sentinel group completes their 7-day observation period without triggering halting rules and is approved to proceed by the DSMB, we will enroll the next 27 participants (Cohort 2) with a 2:1 randomization into the high-dose (n=18) and standard-dose (n=9) groups. All 20 participants in the mid-dose group will be enrolled prior to the enrollment of the high-dose group.
We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines. Randomization with be done by the UCLA Clinical and Translational Science Institute (CTSI) statistics team based on scheduled participants prior to the study visit. The 6 participants in the sentinel (n=4) and initial (n=2) groups (Table 1) will be assigned into the 3 groups based on their scheduled visit day.
Conditions
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Lung Transplant Recipient
SARS-CoV-2
Immunosuppression
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Groups will be enrolled as follows:
1. Mid-dose - Sentinel group, n=2
2. Standard-dose - Initial group, n=2
3. Cohort 1: 2:1 Randomization into
* Mid-dose group, n=18
* Standard-dose group, n=9
4. High-dose - Sentinel group, n=2
5. Cohort 2: 2:1 Randomization into
* High-dose group, n=18
* Standard-dose group, n=9
We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines.
1. Mid-dose - Sentinel group, n=2
2. Standard-dose - Initial group, n=2
3. Cohort 1: 2:1 Randomization into
* Mid-dose group, n=18
* Standard-dose group, n=9
4. High-dose - Sentinel group, n=2
5. Cohort 2: 2:1 Randomization into
* High-dose group, n=18
* Standard-dose group, n=9
We will perform stratified randomization for the two cohorts based on: 1) the number of prior doses, and 2) prior receipt of any BNT162b2 vaccines.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Standard-dose
mRNA-1273 (Moderna COVID-19 vaccine) 50 ug
Group Type
ACTIVE_COMPARATOR
mRNA-1273 (Moderna COVID-19 vaccine)
Intervention Type
DRUG
Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
Mid-Dose
mRNA-1273 (Moderna COVID-19 vaccine) 100 ug
Group Type
EXPERIMENTAL
mRNA-1273 (Moderna COVID-19 vaccine)
Intervention Type
DRUG
Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
High-Dose
mRNA-1273 (Moderna COVID-19 vaccine) 200 ug
Group Type
EXPERIMENTAL
mRNA-1273 (Moderna COVID-19 vaccine)
Intervention Type
DRUG
Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
Interventions
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mRNA-1273 (Moderna COVID-19 vaccine)
Study Drug will be administered via intramuscular injection (IM). Only one dose of study drug will be administered for the study.
Intervention Type
DRUG
Eligibility Criteria
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Exclusion Criteria
1. Previous documented COVID-19 infection.
2. Use of investigational agents for prophylaxis against COVID-19 within 90 days of the start of the study, including Evusheld monoclonal antibodies.
3. Ongoing therapy for acute cellular or antibody mediated rejection.
4. Intravenous immunoglobulins (IVIG) administration within the prior 3 months or ongoing IVIG therapy.
5. Anaphylaxis or allergic reaction to any prior vaccines.
6. History of anaphylaxis or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
7. Is acutely ill or febrile 24 hours prior to or at the Day 1 visit. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
8. Pregnant or breastfeeding.
9. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
10. Known history of hypertension (HTN) with systolic blood pressure (BP) \> 180 mm Hg at the Day 1 visit.
11. Known history of hypotension with systolic blood pressure \< 85 mm Hg at the Day 1 visit.
12. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
13. Active malignancy diagnosed within previous 4 years (excluding non-melanoma skin cancer).
14. Received a major surgery including lung transplantation in the past 3 months.
2. Use of investigational agents for prophylaxis against COVID-19 within 90 days of the start of the study, including Evusheld monoclonal antibodies.
3. Ongoing therapy for acute cellular or antibody mediated rejection.
4. Intravenous immunoglobulins (IVIG) administration within the prior 3 months or ongoing IVIG therapy.
5. Anaphylaxis or allergic reaction to any prior vaccines.
6. History of anaphylaxis or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
7. Is acutely ill or febrile 24 hours prior to or at the Day 1 visit. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
8. Pregnant or breastfeeding.
9. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
10. Known history of hypertension (HTN) with systolic blood pressure (BP) \> 180 mm Hg at the Day 1 visit.
11. Known history of hypotension with systolic blood pressure \< 85 mm Hg at the Day 1 visit.
12. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
13. Active malignancy diagnosed within previous 4 years (excluding non-melanoma skin cancer).
14. Received a major surgery including lung transplantation in the past 3 months.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Sponsor Role
collaborator
University of California, Los Angeles
OTHER
Sponsor Role
lead
Responsible Party
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Michael Y. Shino, MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yusaku Michael Shino, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Clinical Translational Research Center
Los Angeles, California, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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22-000192
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE2
Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
NCT05483725
ACTIVE_NOT_RECRUITING
Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation
NCT01230502
TERMINATED
NA
Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
NCT02188719
TERMINATED
PHASE1
Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor
NCT00476515
WITHDRAWN
PHASE1
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
NCT04473924
WITHDRAWN
PHASE2
Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against COVID-19 in Patients Undergoing Solid Organ Transplantation.
NCT05048940
WITHDRAWN
PHASE3
Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant
NCT00167791
WITHDRAWN
NA
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
NCT04294459
TERMINATED
PHASE1/PHASE2
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
NCT00286871
COMPLETED
PHASE1
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
NCT01022476
COMPLETED
PHASE1/PHASE2
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
NCT06948097
NOT_YET_RECRUITING
PHASE1
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
NCT03388008
COMPLETED
PHASE2
Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response
NCT04961229
UNKNOWN
PHASE4
Steroid Free Immunosuppression in Liver Transplantation
NCT00296244
COMPLETED
PHASE4
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
NCT01649388
WITHDRAWN
PHASE2
RituxiMab INDuction in Renal Transplantation
NCT01095172
UNKNOWN
PHASE4
A Pilot Trial of Pediatric Liver Transplantation Without Steroids
NCT00694408
TERMINATED
PHASE3
Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation
NCT03968588
COMPLETED
PHASE4
Safety Study of Using Regulatory T Cells Induce Liver Transplantation Tolerance
NCT01624077
UNKNOWN
PHASE1
COVID-19 3rd Dose Vaccine in Transplant Patients
NCT05047640
TERMINATED
PHASE3
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
NCT05324319
UNKNOWN
PHASE2
Minocycline Administration During Human Liver Transplantation
NCT02712775
WITHDRAWN
PHASE4