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

Study Purpose

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 second dose of mRNA-1273.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 3 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, 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04860297
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

SARS-CoV-2
Arms & Interventions

Arms

Experimental: mRNA-1273

Participants will receive 2 intramuscular (IM) injections of 100 microgram (ug) mRNA-1273 on Day 1 and Day 29.

Interventions

Biological: - mRNA-1273

Sterile liquid for injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.

Piedmont Transplant Institute
Recruiting | Atlanta, Georgia, United States, 30309
See if you Qualify
University of Washington Medical Center
Not yet recruiting | Seattle, Washington, United States, 98195
See if you Qualify