This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A vaccine trial for COVID-19

A study to test an investigational vaccine that may protect people from getting sick if they come into contact with the SARS-CoV-2 virus, which causes COVID-19; also known as coronavirus.

Trial ID: NCT04470427

Moderna’s Commitment to Diversity & Inclusion

Moderna is committed to researching a safe and effective vaccine that protects people from all backgrounds against COVID-19.

People from racial and ethnic minority groups are at even greater risk of getting sick and dying from COVID-19. Given that certain populations can respond differently to medical therapies, it is important that study volunteers from all races and ethnicities participate in the COVE Study to ensure the vaccine is safe and effective for everyone to use.

Moderna has proudly partnered with 99 clinical research sites across the US, and we actively collaborate with nonprofits, local community organizations, and faith and cultural leaders to address current and historical barriers, build trust, and raise awareness of this important clinical trial to communities at highest risk of COVID-19.

Trial Details

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Study volunteers will participate and be followed by medical staff for up to two years. The study doctor and medical staff will talk to you about additional medical support that you will receive if you experience COVID-19 symptoms at any time while in this clinical trial. Insurance is not needed to join this clinical trial, and compensation for your time will be available.

Estimated Enrollment

30,000 participants

Given that certain populations can respond differently to medical therapies, it is extremely important that this clinical trial include people from all races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

Phase

3

Eligibility Criteria

Participants must:
  • Be 18 years of age and older
  • Have never tested positive for COVID-19
  • Have a greater chance of becoming infected with COVID-19. Examples include:
    • Living in crowded conditions such as shared housing
    • Working in close contact with the public or other workers including “essential work” settings: healthcare facilities, farms, factories, grocery stores, restaurants, daycares, and public safety/transportation
    • You have underlying medical conditions
    • You are 65 or older
Participants must not:
  • Have been in close contact with anyone that has tested positive for COVID-19 in the past month
  • Be pregnant or breastfeeding
  • Have participated in another trial in the past month

Commitments from you

What's Involved

The total length of trial participation is two years and includes seven visits to the study clinic and monthly phone calls from the study doctor.

  • Study volunteers will be given two injections in the upper arm – one month apart. Each study volunteer has a 50% chance of receiving the mRNA-1273 study vaccine and a 50% chance of receiving the placebo (like flipping a coin).
  • Study volunteers will come back to the research clinic four more times within the next 12 months.
  • Study Volunteers will get a call from the study doctor after each injection, and then monthly after that to monitor for COVID-19 symptoms. During these phone calls, the study doctor and medical staff will check how each study volunteer is feeling and ask for updates on their health.
  • Study volunteers are given a hand-held electronic diary (similar to an iPhone) and will also be asked to complete weekly entries about any COVID-19 symptoms for the duration of the COVE Study.
  • Study volunteers will have their final visit to the research clinic about two years from the date of their second injection.

You will need to travel to one of the 100 sites taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Saint Louis, Missouri, United States
  • Austin, Texas, United States
  • Chicago, Illinois, United States
  • Jacksonville, Florida, United States
  • Glendale, Arizona, United States
  • Newton, Kansas, United States
  • La Mesa, California, United States
  • Boston, Massachusetts, United States
  • Decatur, Georgia, United States
  • Colorado Springs, Colorado, United States
  • Tucson, Arizona, United States
  • Oklahoma City, Oklahoma, United States
  • Little Rock, Arkansas, United States
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Banning, California, United States
  • Rockville, Maryland, United States
  • Omaha, Nebraska, United States
  • Redding, California, United States
  • New York, New York, United States
  • Baton Rouge, Louisiana, United States
  • Grand Island, Nebraska, United States
  • Cincinnati, Ohio, United States
  • Charlotte, North Carolina, United States
  • Melbourne, Florida, United States
  • Norfolk, Nebraska, United States
  • Miami, Florida, United States
  • West Palm Beach, Florida, United States
  • Petal, Mississippi, United States
  • Salt Lake City, Utah, United States
  • Laredo, Texas, United States
  • Medford, Oregon, United States
  • Dallas, Texas, United States
  • Nashville, Tennessee, United States
  • Chattanooga, Tennessee, United States
  • Philadelphia, Pennsylvania, United States
  • Anderson, South Carolina, United States
  • Fort Worth, Texas, United States
  • Galveston, Texas, United States
  • Tomball, Texas, United States
  • Houston, Texas, United States
  • Hollywood, Florida, United States
  • Greenville, South Carolina, United States
  • Baltimore, Maryland, United States
  • Newark, New Jersey, United States
  • Binghamton, New York, United States
  • Metairie, Louisiana, United States
  • McAllen, Texas, United States
  • Wichita, Kansas, United States
  • Winston-Salem, North Carolina, United States
  • Washington, District of Columbia, United States
  • Hackensack, New Jersey, United States
  • Knoxville, Tennessee, United States
  • Dakota Dunes, South Dakota, United States
  • Spartanburg, South Carolina, United States
  • Aurora, Colorado, United States
  • Orlando, Florida, United States
  • Chapel Hill, North Carolina, United States
  • Atlanta, Georgia, United States
  • Mount Pleasant, South Carolina, United States
  • Stockbridge, Georgia, United States
  • Chandler, Arizona, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • Chicago, Illinois

Currently Inactive

  • (Awaiting confirmation) Cleveland, Ohio, United States
  • (Awaiting confirmation) Rockville, Maryland, United States
  • (Awaiting confirmation) Raleigh, North Carolina, United States
  • (Awaiting confirmation) Cedar Park, Texas, United States
  • (Awaiting confirmation) Lenexa, Kansas, United States
  • (Awaiting confirmation) Chicago, Illinois, United States
  • (Awaiting confirmation) Savannah, Georgia, United States
  • (Awaiting confirmation) San Diego, California, United States
  • (Awaiting confirmation) La Jolla, California, United States
  • (Awaiting confirmation) Detroit, Michigan, United States
  • (Awaiting confirmation) Fayetteville, North Carolina, United States
  • (Awaiting confirmation) Las Vegas, Nevada, United States
  • (Awaiting confirmation) San Antonio, Texas, United States
  • (Awaiting confirmation) Houston, Texas, United States
  • (Awaiting confirmation) San Angelo, Texas, United States
  • (Awaiting confirmation) Pittsburgh, Pennsylvania, United States
  • (On hold) Miami, Florida, United States
  • (On hold) Wilmington, North Carolina, United States
  • (On hold) Austin, Texas, United States
  • (On hold) DeLand, Florida, United States

Potential Benefits

The study vaccine is investigational as effectiveness and safety have not been established. There is no guarantee that the study vaccine will become commercially available.
  • Contribute to a potential solution that could solve a global health crisis.
  • Close monitoring and support by the study staff.

Potential Risks

  • The investigational vaccine may cause serious side effects or be uncomfortable.
  • The investigational vaccine may not work.
  • You might receive the placebo.
  • Participation in this clinical trial could inconvenience you. For example, you will need to travel to the study site several times over a two-year period.
  • There may be unknown side effects of the investigational vaccine (short and long term).

Frequently Asked Questions (FAQ)