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Clinical Trials in the USA / NCT06686654
Active, not recruiting Phase 1/2

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

NCT06686654 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi Pasteur, a Sanofi Company
Phase
Phase 1/2
Started
2024-11-11
Last updated
2025-12-11

Condition(s) studied

Human Metapneumovirus ImmunizationRespiratory Syncytial Virus Immunization

Investigational drug(s) / intervention(s)

Investigational hMPV/RSV vaccineInvestigational hMPV vaccine (monovalent)Investigational RSV vaccine (monovalent)Licensed RSV VaccinePlaceboInvestigational RSV+hMPV vaccine →

Investigational hMPV/RSV vaccine: Investigational hMPV/RSV vaccine administered intramuscularly

Investigational hMPV vaccine (monovalent): Investigational hMPV vaccine (monovalent) administered intramuscularly

Investigational RSV vaccine (monovalent): Investigational RSV vaccine (monovalent) administered intramuscularly

Licensed RSV Vaccine: Licensed RSV vaccine administered intramuscularly

Placebo: Placebo administered intramuscularly

Investigational RSV+hMPV vaccine: Investigational RSV+hMPV vaccine administered intramuscularly

Study summary

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

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

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

Trial sites (24)

FacilityCityRegionStatus
Velocity Clinical Research, Phoenix- Site Number : 8400025 Phoenix Arizona
CenExel CNS-Garden Grove- Site Number : 8400017 Garden Grove California
National Research Institute - Gardena- Site Number : 8400005 Gardena California
National Research Institute - Huntington Park- Site Number : 8400014 Huntington Park California
Velocity Clinical Research - San Diego- Site Number : 8400008 La Mesa California
Velocity Clinical Research Los Angeles- Site Number : 8400013 Los Angeles California
National Research Institute - Panorama City- Site Number : 8400012 Los Angeles California
Providence Clinical Research - North Hollywood- Site Number : 8400018 North Hollywood California
Peninsula Research Associates- Site Number : 8400002 Rolling Hills Estates California
Velocity Clinical Research - Denver- Site Number : 8400016 Englewood Colorado
Velocity Clinical Research - Washington DC- Site Number : 8400007 Washington D.C. District of Columbia
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022 Hallandale Florida
Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001 Miami Florida
Velocity Clinical Research - Meridian- Site Number : 8400003 Meridian Idaho
Velocity Clinical Research - Kansas City- Site Number : 8400015 Overland Park Kansas
Velocity Clinical Research - Rockville- Site Number : 8400011 Rockville Maryland
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023 Lincoln Nebraska
Velocity Clinical Research - Omaha- Site Number : 8400006 Omaha Nebraska
Velocity Clinical Research - Springdale- Site Number : 8400004 Cincinnati Ohio
Velocity Clinical Research - Medford- Site Number : 8400024 Medford Oregon
Velocity Clinical Research - Austin- Site Number : 8400020 Cedar Park Texas
Velocity Clinical Research - Salt Lake City- Site Number : 8400010 West Jordan Utah
Velocity Clinical Research - Hampton- Site Number : 8400026 Hampton Virginia
Velocity Clinical Research - Seattle- Site Number : 8400019 Seattle Washington

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Other trials for the same condition

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older 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 NCT06686654 on ClinicalTrials.gov ↗ ← All trials in the USA