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Completed

NCT Number: NCT06237296

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

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

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Key information

Conditions

Respiratory Syncytial Virus Infection Healthy Volunteers Infections Metapneumovirus Infection Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number : 0360006, Blacktown, New South Wales, Australia

Loading trial locations.

About this study

Study duration per participant is approximately 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RSV/hMPV mRNA LNP 1

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

RSV/hMPV mRNA LNP 2

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

RSV mRNA LNP 1

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

hMPV mRNA LNP 1

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Primary outcomes

  1. Presence of unsolicited systemic immediate adverse events (AEs)

    Time frame: Within 30 minutes after vaccination

    Number of participants experiencing immediate an immediate unsolicited systemic adverse event

  2. Presence of solicited injection site or systemic reactions

    Time frame: Within 7 days after vaccination

    Number of participants reporting:

    • injection site reactions: pain, erythema and swelling
    • systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills

  3. Presence of unsolicited AEs

    Time frame: Within 28 days after vaccination

    Number of participants experiencing unsolicited AEs

  4. Presence of medically attended adverse events (MAAEs)

    Time frame: Throughout study (up to approximately 6 months)

    Number of participants experiencing MAAEs

  5. Presence of serious adverse events (SAEs)

    Time frame: Throughout study (up to approximately 6 months)

    Throughout study (up to approximately 6 months)

  6. Presence of adverse events of special interest (AESIs)

    Time frame: Throughout study (up to approximately 6 months)

    Number of participants experiencing AESIs

  7. Presence of out-of-range biological test results

    Time frame: Within 7 days after vaccination

    Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)

  8. RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations

    Time frame: Day 1 and Day 29

    RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

  9. RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations

    Time frame: Day 1 and Day 29

    RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

  10. hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations

    Time frame: Day 1 and Day 29

    hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

Secondary outcomes

  1. RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

    Time frame: Day 1, Day 29, Day 91 and Day 181

    RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

  2. RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

    Time frame: Day 1, Day 29, Day 91 and Day 181

    RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

  3. RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

    Time frame: Day 1, Day 29, Day 91 and Day 181

    RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

  4. hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations

    Time frame: Day 1, Day 29, Day 91 and Day 181

    hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

  5. hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations

    Time frame: Day 1, Day 29, Day 91 and Day 181

    hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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