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
2 other identifiers
interventional
1,530
1 country
24
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2024
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 18, 2027
December 11, 2025
December 1, 2025
2.2 years
November 11, 2024
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
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
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
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)
Secondary Outcomes (8)
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)
At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 1)
At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
hMPV A serum nAb titers (Stage 2 Expansion Cohort)
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)
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)
At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
- +3 more secondary outcomes
Study Arms (19)
Group A Stage 1 Sentinel Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation A
Group B Stage 1 Sentinel Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation B
Group C Stage 1 Sentinel Cohort
PLACEBO COMPARATOR1 IM injection of placebo
Group 1 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation C
Group 2 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation D
Group 3 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation E
Group 4 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation F
Group 5 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation G
Group 6 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation A
Group 7 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation B
Group 8 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation H
Group 9 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation I
Group 10 Stage 1 Main Cohort
EXPERIMENTAL1 IM injection of investigational hMPV/RSV vaccine formulation J
Group 11 Stage 1 Main Cohort
PLACEBO COMPARATOR1 IM injection of placebo
Group X Stage 2 Expansion Cohort
EXPERIMENTAL1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort
Group 12 Stage 2 Expansion Cohort
EXPERIMENTAL1 IM injection of investigational RSV monovalent vaccine
Group 13 Stage 2 Expansion Cohort
EXPERIMENTAL1 IM injection of investigational hMPV monovalent vaccine
Group 14 Stage 2 Expansion Cohort
EXPERIMENTAL1 IM injection of licensed RSV vaccine
Group 15 Stage 2 Booster Cohort
EXPERIMENTAL1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort
Interventions
Investigational hMPV/RSV vaccine administered intramuscularly
Investigational hMPV vaccine (monovalent) administered intramuscularly
Investigational RSV vaccine (monovalent) administered intramuscularly
Licensed RSV vaccine administered intramuscularly
Placebo administered intramuscularly
Investigational RSV+hMPV vaccine administered intramuscularly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Velocity Clinical Research, Phoenix- Site Number : 8400025
Phoenix, Arizona, 85006, United States
CenExel CNS-Garden Grove- Site Number : 8400017
Garden Grove, California, 92845, United States
National Research Institute - Gardena- Site Number : 8400005
Gardena, California, 90247, United States
National Research Institute - Huntington Park- Site Number : 8400014
Huntington Park, California, 90255, United States
Velocity Clinical Research - San Diego- Site Number : 8400008
La Mesa, California, 91942, United States
Velocity Clinical Research Los Angeles- Site Number : 8400013
Los Angeles, California, 90017, United States
National Research Institute - Panorama City- Site Number : 8400012
Los Angeles, California, 91402, United States
Providence Clinical Research - North Hollywood- Site Number : 8400018
North Hollywood, California, 91606, United States
Peninsula Research Associates- Site Number : 8400002
Rolling Hills Estates, California, 90274, United States
Velocity Clinical Research - Denver- Site Number : 8400016
Englewood, Colorado, 80110, United States
Velocity Clinical Research - Washington DC- Site Number : 8400007
Washington D.C., District of Columbia, 20016, United States
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
Hallandale, Florida, 33009, United States
Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001
Miami, Florida, 33173, United States
Velocity Clinical Research - Meridian- Site Number : 8400003
Meridian, Idaho, 83642, United States
Velocity Clinical Research - Kansas City- Site Number : 8400015
Overland Park, Kansas, 66210, United States
Velocity Clinical Research - Rockville- Site Number : 8400011
Rockville, Maryland, 20854, United States
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research - Omaha- Site Number : 8400006
Omaha, Nebraska, 68134, United States
Velocity Clinical Research - Springdale- Site Number : 8400004
Cincinnati, Ohio, 45246, United States
Velocity Clinical Research - Medford- Site Number : 8400024
Medford, Oregon, 97504, United States
Velocity Clinical Research - Austin- Site Number : 8400020
Cedar Park, Texas, 78613, United States
Velocity Clinical Research - Salt Lake City- Site Number : 8400010
West Jordan, Utah, 84088, United States
Velocity Clinical Research - Hampton- Site Number : 8400026
Hampton, Virginia, 23666, United States
Velocity Clinical Research - Seattle- Site Number : 8400019
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Stage 1 Sentinel and Main Cohorts: observer-blind; for safety evaluation purposes, the Sponsor Safety Management Team (SMT) will be unblinded for the Sentinel Cohort (including early safety data review \[ESDR\]) and will be blinded for the Main Cohort. Stage 2 Expansion Cohort: observer-blind until all participants complete the Month 6 visit, then open-label Stage 2 Booster Cohort: open-label
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
January 18, 2027
Study Completion (Estimated)
January 18, 2027
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
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