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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    240
  • sponsor
    ModernaTX, Inc.
Updated on 31 July 2021

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.

Details
Condition Sars Cov 2
Treatment mRNA-1273
Clinical Study IdentifierNCT04860297
SponsorModernaTX, Inc.
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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