New COVID vaccine trial aims to outsmart evolving variants
NCT ID NCT07089706
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests an updated COVID-19 vaccine (mRNA-1283) designed to protect against current virus variants. About 832 people aged 12 and older, especially those at higher risk, will receive the vaccine. Researchers will measure immune response and monitor for side effects to ensure the vaccine is safe and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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832 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subprotocol 1: * ≥65 years of age at the time of signing the informed consent or ≥12 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19. * Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. * Participants who are assigned female at birth or could become pregnant: i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1. ii) 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). iii) Has agreed to continue adequate contraception through 28 days following vaccine administration. Exclusion Criteria: Subprotocol 1: * History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment. * Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Receipt of the COVID-19 vaccine within 6 months prior to enrollment. * Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention. * Receipt of systemic immunosuppressants for \>14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. * History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. * Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection. Note: Other protocol-specified inclusion and exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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DelRicht Research-Atlanta
Atlanta, Georgia, 30329, United States
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DelRicht Research-Baton Rouge
Baton Rouge, Louisiana, 70769, United States
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DelRicht Research-Gulfport
Gulfport, Mississippi, 39503, United States
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DelRicht Research-New Orleans
New Orleans, Louisiana, 70115, United States
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DelRicht Research-Tulsa
Tulsa, Oklahoma, 74133, United States
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Other studies related to the condition(s) this trial covers.
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