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Moderna's CMV vaccine shows promise in Long-Term Follow-Up study

NCT ID NCT04975893

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is a long-term follow-up of a phase 2 trial testing Moderna's mRNA-1647 vaccine against cytomegalovirus (CMV). It involves 135 adults who previously received the vaccine or a placebo. Researchers are checking how long the immune response lasts and whether a booster dose is safe and effective. The goal is to eventually prevent CMV infection, which can be dangerous for pregnant women and people with weak immune systems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1647 vaccine
What this could lead to
If successful, this could support the development of a vaccine to prevent cytomegalovirus (CMV) infection, which can cause serious complications in newborns and people with weakened immune systems.
What could go wrong
This is a small, early-phase extension study focused on long-term immune persistence and safety, not on proving the vaccine prevents infection. The results may not confirm effectiveness, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

135 people

The number who actually took part.

Started

Jun 2021

Finished

Jan 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

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Primary Extension Phase: * Male and female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT. * Male and female participants who were CMV-seropositive at the Study mRNA-1647-P202 Screening visit, were randomized to receive mRNA-1647 injection (and not placebo), and completed the final visit in Study mRNA-1647-P202. * Understands and agrees to comply with the trial procedures and provides written informed consent. * According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures. Optional Booster Phase: For BD Recipients: \- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 medium dose injection (and not placebo or other dose levels) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to receive a BD in the optional BP. For Observational Group: \- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 low dose or high dose injection (and not placebo or mRNA-1647 medium dose injection) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to enroll in the observational group. Exclusion Criteria: Primary Extension Phase: * Receipt of any CMV vaccine other than mRNA-1647. * Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. Optional Booster Phase: For BD Recipients: \- Participants from the placebo, mRNA-1647 low dose, or mRNA-1647 medium dose groups in Study mRNA-1647-P202. For Observational Group: \- Participants from the placebo or mRNA-1647 medium dose groups in study mRNA-1647-P202. Note: Other protocol-defined inclusion/exclusion criteria 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

  • Alliance for Multispeciality Research, LLC

    Lexington, Kentucky, 40509, United States

  • Crossroads Clinical Research (Victoria)

    Victoria, Texas, 77901, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84109, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121, United States

  • Johnson County Clin-Trials, Inc.

    Lenexa, Kansas, 66219, United States

  • Optimal Research, LLC

    Peoria, Illinois, 61610, United States

  • Tekton Research Inc

    Austin, Texas, 78745, United States

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