New COVID vaccine trial aims to outsmart evolving variants

NCT ID NCT07089706

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

832 people

The number who actually took part.

Started

Jul 2025

Finished

Jun 2026

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • DelRicht Research-Atlanta

    Atlanta, Georgia, 30329, United States

  • DelRicht Research-Baton Rouge

    Baton Rouge, Louisiana, 70769, United States

  • DelRicht Research-Gulfport

    Gulfport, Mississippi, 39503, United States

  • DelRicht Research-New Orleans

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research-Tulsa

    Tulsa, Oklahoma, 74133, United States

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