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
- 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
- Short title
- 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
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-01-18
- First posted
- 2024-11-13
- Registry last updated
- 2025-12-11
- Primary completion date
- 2027-01-18
- Start date
- 2024-11-11
- Actual participants
- 1,530
- Participants
- 1,530
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06686654
- ClinicalTrials.gov ID
- NCT06686654
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masking description
- 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
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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)
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)
Timeframe: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
RSV serum anti-F IgG Ab titers (Stage 1)
Timeframe: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
hMPV A serum nAb titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
hMPV B serum nAb titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
hMPV A serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
RSV A serum nAb titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
RSV serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Timeframe: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Ab titers expressed as geometric mean titers (GMTs)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 60 Years
- Healthy volunteers
- Yes
- 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
- 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.
- Velocity Clinical Research, Phoenix- Site Number : 8400025Phoenix, United States
- CenExel CNS-Garden Grove- Site Number : 8400017Garden Grove, United States
- National Research Institute - Gardena- Site Number : 8400005Gardena, United States
- National Research Institute - Huntington Park- Site Number : 8400014Huntington Park, United States
- Velocity Clinical Research - San Diego- Site Number : 8400008La Mesa, United States
- Velocity Clinical Research Los Angeles- Site Number : 8400013Los Angeles, United States
- National Research Institute - Panorama City- Site Number : 8400012Los Angeles, United States
- Providence Clinical Research - North Hollywood- Site Number : 8400018North Hollywood, United States
- Peninsula Research Associates- Site Number : 8400002Rolling Hills Estates, United States
- Velocity Clinical Research - Denver- Site Number : 8400016Englewood, United States
- Velocity Clinical Research - Washington DC- Site Number : 8400007Washington D.C., United States
- Velocity Clinical Research - Hallandale Beach- Site Number : 8400022Hallandale, United States
- Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001Miami, United States
- Velocity Clinical Research - Meridian- Site Number : 8400003Meridian, United States
- Velocity Clinical Research - Kansas City- Site Number : 8400015Overland Park, United States
- Velocity Clinical Research - Rockville- Site Number : 8400011Rockville, United States
- Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023Lincoln, United States
- Velocity Clinical Research - Omaha- Site Number : 8400006Omaha, United States
- Velocity Clinical Research - Springdale- Site Number : 8400004Cincinnati, United States
- Velocity Clinical Research - Medford- Site Number : 8400024Medford, United States
- Velocity Clinical Research - Austin- Site Number : 8400020Cedar Park, United States
- Velocity Clinical Research - Salt Lake City- Site Number : 8400010West Jordan, United States
- Velocity Clinical Research - Hampton- Site Number : 8400026Hampton, United States
- Velocity Clinical Research - Seattle- Site Number : 8400019Seattle, United States
Other registry identifiers
- U1111-1310-4940