Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
Investigation of a Messenger RNA (mRNA) Vaccine for Respiratory Viruses in Adults
Study Overview
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older.
- Treatment
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- RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
- RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
- RSV mRNA / LNP 1 at 1 dose or,
- hMPV mRNA / LNP 1 at 1 dose
Study Details
Study duration per participant is approximately 6 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
-Informed consent form (ICF) has been signed and dated
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the safety and immune response of an investigational mRNA vaccine aimed at preventing lower respiratory tract diseases caused by respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The study involves healthy participants aged 18 to 49 years and 60 years and older. The purpose is to determine how well the vaccine works and how safe it is for these age groups.
Participants will receive a single intramuscular injection of the investigational vaccine. The vaccine will be administered in different formulations, involving 3 to 4 different doses combined with lipid nanoparticles (LNPs). The study will compare responses to combinations of RSV/hMPV mRNA with two types of LNPs, as well as RSV or hMPV mRNA with a single LNP.
- Who can participate: Participants must be healthy adults aged 18 to 49 years or 60 years and older. They must sign an informed consent form before joining the study. Individuals with conditions that could interfere with the study's objectives will not be eligible.
- Study details: Participants will receive a single intramuscular injection of the investigational vaccine. The study will test several doses and formulations to evaluate safety and immune response.
- Study timelines: The study will last approximately 6 months per participant.
