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Trial record 3 of 38 for:    mRNA-1273 | COVID

A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants

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ClinicalTrials.gov Identifier: NCT04860297
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver transplant and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: mRNA-1273 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label, single treatment study; there is no randomization
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls
Actual Study Start Date : April 16, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: mRNA-1273

All participants (healthy participants and solid organ transplant recipients) will receive 2 intramuscular (IM) injections of 100 microgram (ug) mRNA-1273 on Day 1 and Day 29.

All solid organ transplant recipients will be offered the opportunity to receive a third dose of mRNA-1273 at Day 85.

Biological: mRNA-1273
Sterile liquid for injection




Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 92 (7 days after third dose) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 113 (1 month after third dose) ]
  3. Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  4. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  5. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  6. Number of Participants with Adverse Events (AEs) Leading to Withdrawal [ Time Frame: Up to Day 450 (1 year after third dose) ]
  7. Number of Participants with Biopsy-proven Organ Rejection [ Time Frame: Up to Day 450 (1 year after third dose) ]
  8. Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Up to Day 57 (1 month after second dose) ]

Secondary Outcome Measures :
  1. GMT of SARS-CoV-2 Binding Antibody (bAb) [ Time Frame: Day 1, Day 29, Day 57, Day 113, Day 209, Day 265, Day 394, Day 450 ]
  2. Geometric Mean Fold Rise (GMFR) of bAb Relative to Day 1 [ Time Frame: Day 1, Day 29, Day 57, Day 113, Day 209, Day 265, Day 394, Day 450 ]
  3. The GMT Values of SARS-CoV-2-Specific nAb [ Time Frame: Day 1, Day 29, Day 113, Day 209, Day 265, Day 394, Day 450 ]
  4. GMFR of nAb Relative to Day 1 [ Time Frame: Day 1, Day 29, Day 57, Day 113, Day 209, Day 265, Day 394, Day 450 ]
  5. Number of Transplant Recipients and Number of Healthy Participants (Who had a Negative SARS-CoV-2 at Baseline) with Asymptomatic SARS-CoV-2 Infection [ Time Frame: Day 43 up to approximately Day 450 ]
    Clinical signs indicative of asymptomatic SARS-CoV-2 infection as predefined for the study.

  6. Number of Transplant Recipients and Number of Healthy Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 Days after the Second Dose of Vaccine and after the Third Dose of Vaccine [ Time Frame: Day 43 up to Day 450 ]
    Clinical signs indicative of symptomatic COVID-19 as predefined for the study.

  7. Number of Transplant Recipients and Number of Healthy Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of Vaccine and after the Third Dose of Vaccine [ Time Frame: Day 43 up to Day 450 ]
    Clinical signs indicative of severe COVID-19 as predefined for the study.

  8. Number of Participants with a Change in Immunosuppressant Medications to Treat Organ Transplant Rejection or to Improve Immune Tolerance [ Time Frame: Up to Day 450 (1 year after third dose) ]
    Change in immunosuppressant medication is defined as any of the following: -any adjustments (temporarily or permanently) in immunosuppressants; -addition of new immunosuppressants; -or switching from one maintenance rejection prophylaxis regimen to another

  9. Liver Function Tests Over Time in Transplant Recipients [ Time Frame: Day 1, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113 ]
  10. Kidney Function Tests Over Time in Transplant Recipients [ Time Frame: Day 1, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Transplant Recipients Key Inclusion Criteria

  • Is either a kidney or a liver transplant recipient who is at least 6 months post transplantation at the time of consent.
  • Understands and agrees to comply with the study procedures and provides written informed consent.
  • Is able to comply with study procedures based on the assessment of the investigator.
  • Received chronic immunosuppressive therapy for the prevention of allograft rejection for a minimum of 6 months before signing consent, including but not limited to: glucocorticoids (such as, prednisolone), immunophilin binding agents (such as, calcineurin inhibitors, mTOR inhibitors), or inhibitors of de novo nucleotide synthesis (such as, mycophenolic acid, mizoribine, leflunomide, azathioprine).
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection or 3rd dose, as applicable, and not currently breastfeeding.
  • Is medically stable, according to investigator's judgment, during the 3 months before signing consent.

Key Exclusion Criteria:

  • A history of more than one solid organ transplanted (such as, kidney and pancreas). A history of previous kidney or liver transplant is acceptable.
  • Has received therapies that have depleting properties on T cells, B cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [ATG], monoclonal antibodies, and proteosome inhibitors) within the last 6 months prior to enrollment.
  • A history of biopsy-proven T-cell- or Ab-mediated rejection within 6 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment.
  • Has a known close contact with anyone with laboratory confirmed SARS-CoV-2 infection within 2 weeks to vaccine administration or known history of SARS-CoV-2 infection or positive SARS-CoV-2 test.
  • Has current treatment with investigational agents for either prophylaxis against COVID-19 or treatment of COVID-19 (such as, anti-SARS-CoV-2 monoclonal antibodies).
  • 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.
  • Has a history of clinically relevant donor-specific Ab according to the judgement of the investigator.
  • Has a history of complications of immunosuppression
  • Suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment
  • Known human immunodeficiency virus (HIV) infection
  • Has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
  • Received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
  • Received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
  • Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.

Healthy Participants

Key Inclusion Criteria :

  • In good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent
  • Understands and agrees to comply with the study procedures and provides written informed consent.
  • Is able to comply with study procedures based on the assessment of the investigator.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding.
  • Is medically stable, according to investigator's judgment, during the 3 months before signing consent.

Key Exclusion Criteria:

  • Has a known close contact with anyone with laboratory confirmed SARS-CoV-2 infection within 2 weeks to vaccine administration or known history of SARS-CoV-2 infection or positive SARS-CoV-2 test.
  • Has current treatment with investigational agents for either prophylaxis against COVID-19 or treatment of COVID-19 (such as, anti-SARS-CoV-2 monoclonal antibodies).
  • 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.
  • Has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
  • Received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
  • Received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
  • Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 mg/day of prednisone equivalent).
  • Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860297


Contacts
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Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com

Locations
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United States, Georgia
Piedmont Transplant Institute Recruiting
Atlanta, Georgia, United States, 30309
United States, Washington
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04860297    
Other Study ID Numbers: mRNA-1273-P304
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna