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

Study on an investigational vaccine for respiratory infections in adults

Recruiting
18 years or above
All
Phase 1
545 participants needed
9 Locations

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
  • 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
  • Age: 18 years or above
  • 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.

Updated on 03 Jun 2024. Study ID: NCT06237296

This study investigates the safety and immune response of an investigational vaccine for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). These are viruses that can lead to lung infections. The study involves healthy adults aged 18 to 49 years and those 60 years and older.

Participants will receive a single injection of the vaccine, which will be given in different doses and formulations. The vaccine uses messenger ribonucleic acid (mRNA) technology and is combined with lipid nanoparticles, which help deliver the vaccine into the body.

  • Who can participate: Healthy adults aged 18 to 49 years and those 60 years and older can participate. Participants must sign an informed consent form. Individuals with conditions that might affect study results are excluded.
  • Study details: Participants will receive a single intramuscular injection of the investigational vaccine. The vaccine is given in different doses and formulations to test its effects.
  • Study Timelines: The study will last 6 months for each participant.

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