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Trial record 3 of 49 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.

Tracking Information
First Submitted Date  ICMJE April 21, 2021
First Posted Date  ICMJE April 26, 2021
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE April 16, 2021
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2021)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 92 (7 days after third dose) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 113 (1 month after third dose) ]
  • Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  • Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 450 (1 year after third dose) ]
  • Number of Participants with Adverse Events (AEs) Leading to Withdrawal [ Time Frame: Up to Day 450 (1 year after third dose) ]
  • Number of Participants with Biopsy-proven Organ Rejection [ Time Frame: Up to Day 450 (1 year after third dose) ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Up to Day 57 (1 month after second dose) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after second dose) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (1 month after second dose) ]
  • Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Adverse Events (AEs) Leading to Withdrawal [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Biopsy-proven Organ Rejection [ Time Frame: Up to Day 394 (1 year after the second dose) ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 57 (1 month after second dose) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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.
  • 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.
  • 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.
  • 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
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • GMT of SARS-CoV-2 Binding Antibody (bAb) [ Time Frame: Day 1, Day 29, Day 57, Day 209, Day 394 ]
  • Geometric Mean Fold Rise (GMFR) of bAb Relative to Day 1 [ Time Frame: Day 29, Day 57, Day 209, Day 394 ]
  • The GMT Values of SARS-CoV-2-Specific nAb [ Time Frame: Day 1, Day 29, Day 209, Day 394 ]
  • GMFR of nAb Relative to Day 1 [ Time Frame: Day 29, Day 57, Day 209, Day 394 ]
  • 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 57 up to approximately Day 394 ]
    Clinical signs indicative of asymptomatic SARS-CoV-2 infection as predefined for the study.
  • 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 [ Time Frame: Day 43 up to Day 394 ]
    Clinical signs indicative of symptomatic COVID-19 as predefined for the study.
  • 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 [ Time Frame: Day 43 up to Day 394 ]
    Clinical signs indicative of severe COVID-19 as predefined for the study.
  • Number of Participants with a Change in Imunosuppressant Medications to Treat Organ Transplant Rejection or to Improve Immune Tolerance [ Time Frame: Up to Day 394 (1 year after the second 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
  • Liver Function Tests Over Time in Transplant Recipients [ Time Frame: Day 1, Day 8, Day 29, Day 36, Day 57 ]
  • Kidney Function Tests Over Time in Transplant Recipients [ Time Frame: Day 1, Day 8, Day 29, Day 36, Day 57 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE Biological: mRNA-1273
Sterile liquid for injection
Study Arms  ICMJE 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.

Intervention: Biological: mRNA-1273
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2021)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04860297
Other Study ID Numbers  ICMJE mRNA-1273-P304
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP