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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
Sponsor: Sanofi Pasteur, a Sanofi Company
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
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
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1530
Start Date
2024-11-11
Completion Date
2027-01-18
Last Updated
2025-12-11
Healthy Volunteers
Yes
Interventions
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
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 D.C., District of Columbia, United States
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
Hallandale, 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