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ACTIVE NOT RECRUITING
NCT06686654
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Investigational hMPV/RSV vaccine

Investigational hMPV/RSV vaccine administered intramuscularly

BIOLOGICAL

Investigational hMPV vaccine (monovalent)

Investigational hMPV vaccine (monovalent) administered intramuscularly

BIOLOGICAL

Investigational RSV vaccine (monovalent)

Investigational RSV vaccine (monovalent) administered intramuscularly

BIOLOGICAL

Licensed RSV Vaccine

Licensed RSV vaccine administered intramuscularly

BIOLOGICAL

Placebo

Placebo administered intramuscularly

BIOLOGICAL

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