A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

Study Purpose

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years 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

Inclusion Criteria:

  • - Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
  • - Understands and agrees to comply with the study procedures and provides written informed consent.
  • - Able to comply with study procedures based on the assessment of the Investigator.
  • - Female participants of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
  • - Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
  • - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
  • - Has agreed to continue adequate contraception through 3 months following the second dose on Day 29.
  • - Is not currently breastfeeding.
  • - Healthy adults or adults with pre-existing medical conditions who are in stable condition.
A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. Additional Inclusion Criteria for Part B: Participants who were previously enrolled in the mRNA-1273-P301 study and chose to be unblinded.

Exclusion Criteria:

  • - Is acutely ill or febrile 72 hours prior to or at Screening.
Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. 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.
  • - Is pregnant or breastfeeding.
  • - (Part A Only) Known history of SARS-CoV-2 infection.
  • - Prior administration of an investigational coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
  • - (Part A Only) Demonstrated inability to comply with the study procedures.
  • - (Part A Only) An immediate family member or household member of this study's personnel.
  • - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
  • - Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  • - Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine).
  • - Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
  • - Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
  • - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).
  • - Has received systemic immunoglobulins or blood products within 3 months prior to the day of Screening.
  • - Has donated ≥450 milliliters (mL) of blood products within 28 days prior to Screening.

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.

NCT04470427
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.

IndustryU.S. FedNIH
Overall Status Active, not recruiting
Countries United States
Conditions

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

SARS-CoV-2
Study Website: View Trial Website
Additional Details

This is a 2-part Phase 3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer participants to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally, participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B. Please access www.modernatx.com/cove-study for additional information, such as Study Overview, Participation, and Site Locations along with contact numbers for each location for the study.

Arms & Interventions

Arms

Experimental: mRNA-1273

Part A: Participants will receive 1 intramuscular (IM) injection of 100 microgram (ug) mRNA-1273 on Day 1 and on Day 29. Part B: Participants who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29, if the participant chooses. Participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1, if the participant chooses.

Placebo Comparator: Placebo

Part A only: Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29, if the participant chooses.

Interventions

Biological: - mRNA-1273

Sterile liquid for injection

Biological: - Placebo

0.9% sodium chloride (normal saline) 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.

Ascension St. Vincent Birmingham
Birmingham, Alabama, United States, 35205
See if you Qualify
Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, United States, 35211
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Hope Research Institute
Chandler, Arizona, United States, 85224
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Synexus Clinical Research US, Inc. - Phoenix West
Glendale, Arizona, United States, 85306
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Hope Research Institute
Peoria, Arizona, United States, 85018
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Hope Research Institute
Phoenix, Arizona, United States, 85018
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Quality of Life Medical and Research Center
Tucson, Arizona, United States, 85712
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Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
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Advanced Clinical Research - Rancho Paseo
Banning, California, United States, 92220
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University of California San Diego
La Jolla, California, United States, 92093
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eStudySite - La Mesa
La Mesa, California, United States, 91942
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UCLA Vine Street Clinic CRS
Los Angeles, California, United States, 90038
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VA Greater Los Angeles Healthcare (veterans only)
Los Angeles, California, United States, 90073
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Paradigm Clinical Research Institute Inc
Redding, California, United States, 96001
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Benchmark Research - Sacramento
Sacramento, California, United States, 95864
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Medical Center For Clinical Research - M3 Wake Research
San Diego, California, United States, 92108
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University of Colorado Hospital
Aurora, Colorado, United States, 80045
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Lynn Institute of The Rockies
Colorado Springs, Colorado, United States, 80918
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George Washington University
Washington, District of Columbia, United States, 20037
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Accel Research Site
DeLand, Florida, United States, 32720
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Research Centers of America
Hollywood, Florida, United States, 33024
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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
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Synexus - Optimal Research - Melbourne
Melbourne, Florida, United States, 32934
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Suncoast Research Group
Miami, Florida, United States, 33135
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University of Miami
Miami, Florida, United States, 33136
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Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States, 32806
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Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
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Grady Health System
Atlanta, Georgia, United States, 30303
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
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Hope Clinic of The Emory Vaccine Center
Decatur, Georgia, United States, 30030
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Meridian Clinical Research
Savannah, Georgia, United States, 31406
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Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
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Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States, 60602
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UIC Project WISH CRS
Chicago, Illinois, United States, 60612
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University of Chicago-Hospital
Chicago, Illinois, United States, 60637
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Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
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Alliance for Multispecialty Research
Newton, Kansas, United States, 67114
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Alliance for Multispecialty Research- East Wichita
Wichita, Kansas, United States, 67207
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Meridian Clinical Research
Baton Rouge, Louisiana, United States, 70808
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Benchmark Research - Metairie
Metairie, Louisiana, United States, 70006
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University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
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Synexus - Optimal Research - Rockville
Rockville, Maryland, United States, 20850
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Meridian Clinical Research
Rockville, Maryland, United States, 20854
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Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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Henry Ford Health System
Detroit, Michigan, United States, 48202
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MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, United States, 39465
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Saint Louis University
Saint Louis, Missouri, United States, 63104
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Sundance Clinical Research
Saint Louis, Missouri, United States, 63141
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Meridian Clinical Research
Grand Island, Nebraska, United States, 68803
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Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
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Meridian Clinical Research
Omaha, Nebraska, United States, 68134
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Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
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AB Clinical Trials
Las Vegas, Nevada, United States, 89119
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Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
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New Jersey Medical School
Newark, New Jersey, United States, 07103
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Meridian Clinical Research
Binghamton, New York, United States, 13901
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Weill Cornell Chelsea - (CRS)
New York, New York, United States, 10010
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Weill Cornell Medical College
New York, New York, United States, 10065
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
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Tryon Medical Partners
Charlotte, North Carolina, United States, 28210
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Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, United States, 28304
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M3 Wake Research, Inc - M3 Wake
Raleigh, North Carolina, United States, 27612
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Trial Management Associates
Wilmington, North Carolina, United States, 28403
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
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Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States, 45236
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New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
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Cincinnati CRS
Cincinnati, Ohio, United States, 45267
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Rapid Medical Research Inc
Cleveland, Ohio, United States, 44122
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Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
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Crisor
Medford, Oregon, United States, 97504
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University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
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UPMC University Center
Pittsburgh, Pennsylvania, United States, 15213
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Keystone VitaLink Research
Anderson, South Carolina, United States, 29621
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Keystone VitaLink Research - Greenville
Greenville, South Carolina, United States, 29615
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Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
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Keystone VitaLink Research - Spartanburg
Spartanburg, South Carolina, United States, 29303
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Meridian Clinical Research
Dakota Dunes, South Dakota, United States, 57049
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WR-ClinSearch
Chattanooga, Tennessee, United States, 37421
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Alliance for Multispecialty Research
Knoxville, Tennessee, United States, 39720
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Vanderbilt University Medical Center, Medical Arts Building
Nashville, Tennessee, United States, 37232
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Vanderbilt University Medical Center, Medical Center North
Nashville, Tennessee, United States, 37232
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Benchmark Research - Austin
Austin, Texas, United States, 78705
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Synexus - Optimal Research - Austin
Austin, Texas, United States, 78705
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Tekton Research
Austin, Texas, United States, 78745
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Advanced Clinical Research - Be Well MD
Cedar Park, Texas, United States, 78613
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Global Medical Research - M3 Wake Research
Dallas, Texas, United States, 75224
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Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, United States, 75234
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Benchmark Research - Fort Worth
Fort Worth, Texas, United States, 76135
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University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
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Baylor College of Medicine
Houston, Texas, United States, 77030
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DM Clinical Research - Texas Center For Drug Development
Houston, Texas, United States, 77081
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Laguna Clinical Research
Laredo, Texas, United States, 78041
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Centex Studies
McAllen, Texas, United States, 78504
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Benchmark Research - San Angelo
San Angelo, Texas, United States, 76904
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Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
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DM Clinical Research
Tomball, Texas, United States, 77375
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Synexus Clinical Research US, Inc. - Salt Lake City
Murray, Utah, United States, 84123
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Foothill Family Clinic - North
Salt Lake City, Utah, United States, 84109
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Foothill Family Clinic-South Clinic
Salt Lake City, Utah, United States, 84121
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Kaiser Permanente - Seattle
Seattle, Washington, United States, 98101
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