Vaccine candidates for RSV and hMPV in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial examines the safety, tolerability (reactogenicity), and immune response (immunogenicity) of three vaccine profiles, including mRNA-1365 (Profile 2) and two forms of mRNA-1345, in adults aged 65 and older. Participants are in generally good health or have stable chronic conditions and meet specific BMI criteria. The study will monitor adverse events and laboratory values to assess safety and preliminary immune responses across intervention groups. Multiple sites in Quebec and Manchester will enroll participants to compare different vaccine profiles. Results will inform next steps in developing vaccines against RSV and hMPV.

Why it matters

Who can join: the full rules

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.

Where it's running

• Diex Recherche Quebec
  Québec, Quebec, Canada Recruiting
• Diex Recherche Victoraville
  Victoriaville, Quebec, Canada Recruiting
• MAC Clinical Research
  Manchester, Greater Manchester, United Kingdom Not yet recruiting
• Southampton General Hospital, NHS
  Southampton, Hampshire, United Kingdom Not yet recruiting
• Norfolk and Norwich University Hospital, NHS
  Norwich, Norfolk, United Kingdom Not yet recruiting
• University Hospital Birmingham, NHS
  Birmingham, West Midlands, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Moderna WeCareTeam
• Email: WeCareClinicalTrials@modernatx.com
• Phone: 1-866-663-3762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.