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One shot, two viruses? new mRNA vaccine targets RSV and hMPV

NCT ID NCT07764237

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This early-stage trial tests an experimental mRNA vaccine called mRNA-1365 in healthy adults aged 60 and older. The vaccine is designed to trigger immunity against two respiratory viruses—RSV and hMPV—which can cause severe illness in older people. Researchers will evaluate the vaccine's safety and how well it stimulates the immune system, comparing it with other vaccine formulations.

What this could mean

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

Active substance
mRNA-1365 (Profile 2), an experimental mRNA vaccine designed to protect against two respiratory viruses: RSV and hMPV.
What this could lead to
If successful, this vaccine could offer broad protection against two common respiratory viruses in older adults, reducing severe illness and hospitalizations.
What could go wrong
This is an early-phase trial focused on safety and immune response, not proof of effectiveness. The vaccine may cause side effects or fail to generate strong immunity.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 375 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

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

60 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.

Key Inclusion Criteria: * In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination. * Body mass index within the range 18.5 to 35 kg/m2 (inclusive). Key Exclusion Criteria: * 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. * Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin \>Grade 1, or platelets ≥Grade 1. * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures. * History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease. * Participants with immune-mediated (autoimmune) conditions are generally excluded. * Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human metapneuomovirus (HMPV) Respiratory syncytial virus (RSV)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Diex Recherche Quebec

    RECRUITING

    Québec, Quebec, G1V 4T3, Canada

  • Diex Recherche Victoraville

    RECRUITING

    Victoriaville, Quebec, G6P 3Z8, Canada

  • Guys and St. Thomas Hospital, NHS

    NOT_YET_RECRUITING

    London, SE1 7EH, United Kingdom

  • MAC Clinical Research

    NOT_YET_RECRUITING

    Manchester, Greater Manchester, M13 9NQ, United Kingdom

  • Norfolk and Norwich University Hospital, NHS

    NOT_YET_RECRUITING

    Norwich, Norfolk, NR4 7UQ, United Kingdom

  • Royal Free Hospital, NHS

    NOT_YET_RECRUITING

    London, NW3 2QG, United Kingdom

  • Royal Victoria Infirmary, NHS

    NOT_YET_RECRUITING

    Newcastle, NE1 4LP, United Kingdom

  • Southampton General Hospital, NHS

    NOT_YET_RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • St. George University Hospital, NHS

    NOT_YET_RECRUITING

    London, SW17 0RE, United Kingdom

  • University Hospital Birmingham, NHS

    NOT_YET_RECRUITING

    Birmingham, West Midlands, B15 2TH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.