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.
This is a 3-part Phase 3 study, with Part A (Blinded Phase), Part B (Open-label Observational
Phase), and Part C (Booster Dose Phase). Participants in Part A are blinded to their
treatment assignment, with participants receiving either mRNA-1273 vaccine 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 were 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.
In Part C, a booster dose will be provided for all eligible participants who choose to
receive one.
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.
Biological: mRNA-1273
Sterile liquid for injection
Biological: Placebo
0.9% sodium chloride (normal saline) injection
Inclusion Criteria:
- (Part A only) 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, open-label Day 1, and booster 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 last
dose (Day 29, open-label Day 29, and booster dose Day 1).
- 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.
- (Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).
- (Part C Only) Has received at least 1 dose of mRNA-1273 in the current study
(mRNA-1273-P301).
Exclusion Criteria:
- Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part
C). 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/dosed at the
discretion of the Investigator.
- Is pregnant or breastfeeding.
- (Part A Only) Known history of SARS-CoV-2 infection.
- Prior (Part A) or concurrent (Part B and Part C) administration of non-study
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.
- 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 (IP) (except for seasonal influenza vaccine).
- (Part A only) 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 IP dose administration (for corticosteroids ≥20
milligram (mg)/day of prednisone equivalent).
- Has received systemic immunoglobulins or blood products within 3 months prior to the
day of IP dose administration.
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose
administration.
Ascension St. Vincent Birmingham
Birmingham, Alabama, United States
Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, United States
Hope Research Institute
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Phoenix West
Glendale, Arizona, United States
Hope Research Institute
Peoria, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
Quality of Life Medical and Research Center
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Advanced Clinical Research - Rancho Paseo
Banning, California, United States
University of California San Diego
La Jolla, California, United States
eStudySite - La Mesa
La Mesa, California, United States
UCLA Vine Street Clinic CRS
Los Angeles, California, United States
VA Greater Los Angeles Healthcare (veterans only)
Los Angeles, California, United States
Paradigm Clinical Research Institute Inc
Redding, California, United States
Benchmark Research - Sacramento
Sacramento, California, United States
Medical Center For Clinical Research - M3 Wake Research
San Diego, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Lynn Institute of The Rockies
Colorado Springs, Colorado, United States
George Washington University
Washington, District of Columbia, United States
Accel Research Site
DeLand, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Synexus - Optimal Research - Melbourne
Melbourne, Florida, United States
Suncoast Research Group
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Hope Clinic of The Emory Vaccine Center
Decatur, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States
UIC Project WISH CRS
Chicago, Illinois, United States
University of Chicago-Hospital
Chicago, Illinois, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Alliance for Multispecialty Research
Newton, Kansas, United States
Alliance for Multispecialty Research- East Wichita
Wichita, Kansas, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
Benchmark Research - Metairie
Metairie, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Synexus - Optimal Research - Rockville
Rockville, Maryland, United States
Meridian Clinical Research
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, United States
Saint Louis University
Saint Louis, Missouri, United States
Sundance Clinical Research
Saint Louis, Missouri, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New Jersey Medical School
Newark, New Jersey, United States
Meridian Clinical Research
Binghamton, New York, United States
Weill Cornell Chelsea - (CRS)
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Tryon Medical Partners
Charlotte, North Carolina, United States
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville, North Carolina, United States
M3 Wake Research, Inc - M3 Wake
Raleigh, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Cincinnati CRS
Cincinnati, Ohio, United States
Rapid Medical Research Inc
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Crisor
Medford, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC University Center
Pittsburgh, Pennsylvania, United States
Keystone VitaLink Research
Anderson, South Carolina, United States
Keystone VitaLink Research - Greenville
Greenville, South Carolina, United States
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States
Keystone VitaLink Research - Spartanburg
Spartanburg, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, United States
Vanderbilt University Medical Center, Medical Arts Building
Nashville, Tennessee, United States
Vanderbilt University Medical Center, Medical Center North
Nashville, Tennessee, United States
Benchmark Research - Austin
Austin, Texas, United States
Synexus - Optimal Research - Austin
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Advanced Clinical Research - Be Well MD
Cedar Park, Texas, United States
Global Medical Research - M3 Wake Research
Dallas, Texas, United States
Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
DM Clinical Research - Texas Center For Drug Development
Houston, Texas, United States
Laguna Clinical Research
Laredo, Texas, United States
Centex Studies
McAllen, Texas, United States
Benchmark Research - San Angelo
San Angelo, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Synexus Clinical Research US, Inc. - Salt Lake City
Murray, Utah, United States
Foothill Family Clinic - North
Salt Lake City, Utah, United States
Foothill Family Clinic-South Clinic
Salt Lake City, Utah, United States
Kaiser Permanente - Seattle
Seattle, Washington, United States