Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older

NCT07810010 · tracked via the Priya Life Science UK tracker

Sponsor

Sanofi

Phase

Phase 2

Started

2026-09-09

Last updated

2026-09-16

Condition(s) studied

Respiratory Syncytial VirusHuman MetapneumovirusHealthy Volunteers

Investigational drug(s) / intervention(s)

Bivalent RSV+HMPV protein vaccinePlacebo

Bivalent RSV+HMPV protein vaccine: IM injection

Placebo: IM injection

Study summary

Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.

The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).

The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion Exclusion Criteria: * Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded * Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Previous history of Guillain-Barré Syndrome (GBS) * Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcome measure(s)

Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease) — From 14 days to 12 months after vaccination
Occurrence of the first episode of HMPV-LRTD — From 14 days to 12 months after vaccination

Trial sites (16)

Facility	City	Region	Status
Investigational Site Number : 0360008	Bruse	Australian Capital Territory	Recruiting
Investigational Site Number : 0360006	Blacktown	New South Wales	Recruiting
Investigational Site Number : 0360007	Maroubra	New South Wales	Recruiting
Investigational Site Number : 0360002	Albion	Queensland	Recruiting
Investigational Site Number : 0360003	Sippy Downs	Queensland	Recruiting
Investigational Site Number : 0360009	Melbourne	Victoria	Recruiting
Investigational Site Number : 8260012	Cardiff	Cardiff [Caerdydd Gb-crd]	Recruiting
Investigational Site Number : 8261010	Bournemouth	Dorset	Recruiting
Investigational Site Number : 8263010	Dorchester	Dorset	Recruiting
Investigational Site Number : 8260011	London	England	Recruiting
Investigational Site Number : 8262010	Portsmouth	Hampshire	Recruiting
Investigational Site Number : 8260002	Blackpool	Lancashire	Recruiting
Investigational Site Number : 8260007	London	London, City of	Recruiting
Investigational Site Number : 8260005	Witney	Oxfordshire	Recruiting
Investigational Site Number : 8260006	West Kirby	Wirral	Recruiting
Investigational Site Number : 8260004	London	United Kingdom	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07810010 on ClinicalTrials.gov ↗ ← All trials in the UK