Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older

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

The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older.

The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate).

Overall, the study is designed to address the following goals:

• Assess the safety profile of the candidate formulations.
• Describe the immunogenicity profile of the candidate formulations.
• Select the vaccine formulations (dose) for future development.
• Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine.

The study duration is as follows:

-Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort

Treatment duration:

• Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination
• Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination
• Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination
• Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Immunization; Human Metapneumovirus Immunization
• Intervention / Treatment: Biological: Investigational hMPV/RSV vaccine; Biological: Placebo; Biological: Investigational RSV vaccine (monovalent); Biological: Investigational hMPV vaccine (monovalent); Biological: Licensed RSV Vaccine; Biological: Investigational RSV+hMPV vaccine

• Study Type: Interventional
• Enrollment (Actual): 1530
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research, Phoenix- Site Number : 8400025
  • California
    • Garden Grove, California, United States, 92845
      • CenExel CNS-Garden Grove- Site Number : 8400017
    • Gardena, California, United States, 90247
      • National Research Institute - Gardena- Site Number : 8400005
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park- Site Number : 8400014
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research - San Diego- Site Number : 8400008
    • Los Angeles, California, United States, 90017
      • Velocity Clinical Research Los Angeles- Site Number : 8400013
    • Los Angeles, California, United States, 91402
      • National Research Institute - Panorama City- Site Number : 8400012
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research - North Hollywood- Site Number : 8400018
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates- Site Number : 8400002
  • Colorado
    • Englewood, Colorado, United States, 80110
      • Velocity Clinical Research - Denver- Site Number : 8400016
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Velocity Clinical Research - Washington DC- Site Number : 8400007
  • Florida
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Meridian- Site Number : 8400003
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Velocity Clinical Research - Kansas City- Site Number : 8400015
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research - Rockville- Site Number : 8400011
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research - Omaha- Site Number : 8400006
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Velocity Clinical Research - Springdale- Site Number : 8400004
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research - Medford- Site Number : 8400024
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Velocity Clinical Research - Austin- Site Number : 8400020
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research - Salt Lake City- Site Number : 8400010
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Velocity Clinical Research - Hampton- Site Number : 8400026
  • Washington
    • Seattle, Washington, United States, 98105
      • Velocity Clinical Research - Seattle- Site Number : 8400019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

19

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Stage 1 Sentinel Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation A	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group B Stage 1 Sentinel Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation B	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Placebo Comparator: Group C Stage 1 Sentinel Cohort; 1 IM injection of placebo	Biological: Placebo; Placebo administered intramuscularly
Experimental: Group 1 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation C	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 2 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation D	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 3 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation E	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 4 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation F	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 5 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation G	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 6 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation A	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 7 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation B	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 8 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation H	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 9 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation I	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 10 Stage 1 Main Cohort; 1 IM injection of investigational hMPV/RSV vaccine formulation J	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Placebo Comparator: Group 11 Stage 1 Main Cohort; 1 IM injection of placebo	Biological: Placebo; Placebo administered intramuscularly
Experimental: Group X Stage 2 Expansion Cohort; 1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly
Experimental: Group 12 Stage 2 Expansion Cohort; 1 IM injection of investigational RSV monovalent vaccine	Biological: Investigational RSV vaccine (monovalent); Investigational RSV vaccine (monovalent) administered intramuscularly
Experimental: Group 13 Stage 2 Expansion Cohort; 1 IM injection of investigational hMPV monovalent vaccine	Biological: Investigational hMPV vaccine (monovalent); Investigational hMPV vaccine (monovalent) administered intramuscularly
Experimental: Group 14 Stage 2 Expansion Cohort; 1 IM injection of licensed RSV vaccine	Biological: Licensed RSV Vaccine; Licensed RSV vaccine administered intramuscularly
Experimental: Group 15 Stage 2 Booster Cohort; 1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort	Biological: Investigational hMPV/RSV vaccine; Investigational hMPV/RSV vaccine administered intramuscularly; Biological: Investigational RSV+hMPV vaccine; Investigational RSV+hMPV vaccine administered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting immediate unsolicited systemic AEs	Within 30 minutes after primary and booster vaccinations
Presence of solicited injection site and systemic reactions (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting solicited injection site and systemic reactions	Up to 7 days after primary and booster vaccinations
Presence of unsolicited AEs (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting unsolicited AEs	Up to 28 days after primary and booster vaccinations
Presence of medically attended AEs (MAAEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting MAAEs	Up to 6 months after primary and booster vaccinations
Presence of serious AEs (SAEs) and AEs of special interest (AESIs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting SAEs and AESIs	Up to 6 months after primary and booster vaccinations
Presence of related SAEs, related AESIs, and fatal SAEs (regardless of causality) (Stage 1 and Stage 2 Expansion and Booster Cohorts)	Number of participants reporting related SAEs, related AESIs, and fatal SAEs	Throughout the duration of the study (up to approximately 24 months)
Presence of out-of-range biological test results (Stage 1)	Number of participants with out-of-range biological tests	Up to 7 days after primary vaccination
hMPV A serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts	nAb titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts	nAb titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
RSV A serum nAb titers in Stage 1 Sentinel and Main Cohorts	nAb titers expressed as geometric mean titers (GMTs)	At pre vaccination (D01) and 28 days post-primary vaccination (D29)
RSV B serum nAb titers in Stage 1 Sentinel and Main Cohorts	nAb titers expressed as geometric mean titers (GMTs)	At pre vaccination (D01) and 28 days post-primary vaccination (D29)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort	nAb titers expressed as geometric mean titers (GMTs)	At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
Presence of out-of-range biological test results (Stage 2 Booster Cohort)	Number of participants with out-of-range biological tests	Up to 7 days after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 1)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
hMPV A serum nAb titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV B serum nAb titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV A serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV A serum nAb titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV B serum nAb titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)	Ab titers expressed as geometric mean titers (GMTs)	At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• VBD00009 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: RSV; hMPV; respiratory syncytial virus infection; human metapneumovirus infection
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: VBD00009; U1111-1310-4940 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No