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
- Conditions
- Human Metapneumovirus ImmunizationRespiratory Syncytial Virus Immunization
- Interventions
- Biological: PlaceboBiological: Investigational hMPV/RSV vaccineBiological: Investigational RSV vaccine (monovalent)Biological: Investigational hMPV vaccine (monovalent)Biological: Licensed RSV Vaccine
- Registration Number
- NCT06686654
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
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 of the selected formulation administered 12 months after the primary vaccination in a subset of the study population.
The study duration is as follows:
-Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 12 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 selected formulation arm, and participants in the Licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed for 8 months post-vaccination
* Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 12 months post-booster vaccination
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1510
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 11 Stage 1 Main Cohort Placebo 1 IM injection of placebo Group X Stage 2 Expansion Cohort Investigational hMPV/RSV vaccine 1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort Group 12 Stage 2 Expansion Cohort Investigational RSV vaccine (monovalent) 1 IM injection of investigational RSV monovalent vaccine Group 13 Stage 2 Expansion Cohort Investigational hMPV vaccine (monovalent) 1 IM injection of investigational hMPV monovalent vaccine Group 14 Stage 2 Expansion Cohort Licensed RSV Vaccine 1 IM injection of licensed RSV vaccine Group 9 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation I Group 10 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation J Group A Stage 1 Sentinel Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation A Group B Stage 1 Sentinel Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation B Group C Stage 1 Sentinel Cohort Placebo 1 IM injection of placebo Group 1 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation C Group 2 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation D Group 3 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation E Group 4 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation F Group 5 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation G Group 6 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation A Group 7 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation B Group 8 Stage 1 Main Cohort Investigational hMPV/RSV vaccine 1 IM injection of investigational hMPV/RSV vaccine formulation H Group 15 Stage 2 Booster Cohort Investigational hMPV/RSV vaccine 1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group X of Expansion Cohort Group 16 Stage 2 Booster Cohort Placebo 1 IM injection of placebo
- Primary Outcome Measures
Name Time Method 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
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 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)
- Secondary Outcome Measures
Name Time Method RSV B serum nAb titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
RSV A serum nAb titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1) At pre-vaccination (D01) and 28 days (D29) post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
RSV serum anti-F IgG Ab titers (Stage 1) At pre-vaccination (D01) and 28 days (D29) post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
hMPV A serum nAb titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
hMPV B serum nAb titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
hMPV A serum anti-F IgG Ab titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
RSV serum anti-F IgG Ab titers (Stage 2 Expansion Cohort) At pre-vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-primary vaccination Ab titers expressed as geometric mean titers (GMTs)
Trial Locations
- Locations (24)
Velocity Clinical Research, Phoenix- Site Number : 8400025
🇺🇸Phoenix, Arizona, United States
CenExel CNS-Garden Grove- Site Number : 8400017
🇺🇸Garden Grove, California, United States
National Research Institute - Gardena- Site Number : 8400005
🇺🇸Gardena, California, United States
National Research Institute - Huntington Park- Site Number : 8400014
🇺🇸Huntington Park, California, United States
Velocity Clinical Research - San Diego- Site Number : 8400008
🇺🇸La Mesa, California, United States
Velocity Clinical Research Los Angeles- Site Number : 8400013
🇺🇸Los Angeles, California, United States
National Research Institute - Panorama City- Site Number : 8400012
🇺🇸Los Angeles, California, United States
Providence Clinical Research - North Hollywood- Site Number : 8400018
🇺🇸North Hollywood, California, United States
Peninsula Research Associates- Site Number : 8400002
🇺🇸Rolling Hills Estates, California, United States
Velocity Clinical Research - Denver- Site Number : 8400016
🇺🇸Englewood, Colorado, United States
Velocity Clinical Research - Washington DC- Site Number : 8400007
🇺🇸Washington, District of Columbia, United States
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
🇺🇸Hallandale Beach, Florida, United States
Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001
🇺🇸Miami, Florida, United States
Velocity Clinical Research - Meridian- Site Number : 8400003
🇺🇸Meridian, Idaho, United States
Velocity Clinical Research - Kansas City- Site Number : 8400015
🇺🇸Overland Park, Kansas, United States
Velocity Clinical Research - Rockville- Site Number : 8400011
🇺🇸Rockville, Maryland, United States
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023
🇺🇸Lincoln, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400006
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400004
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Medford- Site Number : 8400024
🇺🇸Medford, Oregon, United States
Velocity Clinical Research - Austin- Site Number : 8400020
🇺🇸Cedar Park, Texas, United States
Velocity Clinical Research - Salt Lake City- Site Number : 8400010
🇺🇸West Jordan, Utah, United States
Velocity Clinical Research - Hampton- Site Number : 8400026
🇺🇸Hampton, Virginia, United States
Velocity Clinical Research - Seattle- Site Number : 8400019
🇺🇸Seattle, Washington, United States