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Vaccine for preventing respiratory infections in older adults

A Phase 1/2, Randomized, Observer-blind, Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an hMPV/RSV mRNA Vaccine Candidate in Adult Participants Aged 60 Years and Older

Phase1; Phase2 Interventional Sanofi · NCT06686654

This study is testing a new mRNA vaccine to see if it can safely protect adults aged 60 and older from respiratory infections caused by specific viruses.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment1510 (estimated)
Ages60 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations24 sites (Phoenix, Arizona and 23 other locations)
Trial IDNCT06686654 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and immune response of a new mRNA vaccine designed to protect adults aged 60 and older from infections caused by human metapneumovirus (hMPV) and respiratory syncytial virus (RSV). Participants will receive either the investigational vaccine or a placebo, and the study will assess the vaccine's safety profile and its ability to generate an immune response. Additionally, a booster dose will be administered to a subset of participants 12 months after the initial vaccination to further evaluate its effectiveness. The study spans up to 12 months for some participants, allowing for comprehensive data collection on the vaccine's performance.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 60 years and older who are generally healthy and meet specific inclusion criteria.

Not a fit: Patients with significant immunodeficiencies or those undergoing immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of severe respiratory infections in older adults, improving their overall health outcomes.

How similar studies have performed: Other studies have shown promise with mRNA vaccine approaches for respiratory viruses, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Aged 60 years or older on the day of inclusion
* A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile

Exclusion Criteria:

* Any screening laboratory parameter with laboratory abnormality \> Grade 1 deemed clinically significant by the investigator
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, persons living with stable human immunodeficiency virus (HIV) are not excluded
* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
* History of RSV and/or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Screening electrocardiogram that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
* Laboratory-confirmed thrombocytopenia, contraindicating IM injection, based on investigator's judgment
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection, based on investigator's judgment
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Receipt of any vaccine other than mRNA vaccine in the 28 days preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 28 days following any study intervention administration
* Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
* Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where this trial is running

Phoenix, Arizona and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Human Metapneumovirus ImmunizationRespiratory Syncytial Virus ImmunizationhMPVRSVrespiratory syncytial virus infectionhuman metapneumovirus infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.