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

Phase 1

Completed

• Conditions: Healthy Volunteers; Respiratory Syncytial Virus Infection; Metapneumovirus Infection
• Interventions: Biological: RSV/hMPV mRNA LNP 1; Biological: RSV/hMPV mRNA LNP 2; Biological: RSV mRNA LNP 1; Biological: hMPV mRNA LNP 1

• Registration Number: NCT06237296
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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

Detailed Description

Study duration per participant is approximately 6 months.

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Status Verified: 2025-02
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSV/hMPV mRNA / LNP 1 Group 7	RSV/hMPV mRNA LNP 1	Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.
RSV/hMPV mRNA / LNP 1 Group 1	RSV/hMPV mRNA LNP 1	Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
RSV/hMPV mRNA / LNP 1 Group 2	RSV/hMPV mRNA LNP 1	Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
RSV/hMPV mRNA / LNP 2 Group 4	RSV/hMPV mRNA LNP 2	Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
RSV mRNA / LNP 1 Group 5	RSV mRNA LNP 1	Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.
hMPV mRNA / LNP 1 Group 6	hMPV mRNA LNP 1	Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
RSV/hMPV mRNA / LNP 1 Group 3	RSV/hMPV mRNA LNP 1	Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.

Primary Outcome Measures

Name	Time	Method
Presence of solicited injection site or systemic reactions	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
Presence of adverse events of special interest (AESIs)	Throughout study (up to approximately 6 months)	Number of participants experiencing AESIs
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	Day 1 and Day 29	RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Presence of serious adverse events (SAEs)	Throughout study (up to approximately 6 months)	Throughout study (up to approximately 6 months)
Presence of out-of-range biological test results	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)
Presence of unsolicited systemic immediate adverse events (AEs)	Within 30 minutes after vaccination	Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of unsolicited AEs	Within 28 days after vaccination	Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs)	Throughout study (up to approximately 6 months)	Number of participants experiencing MAAEs
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	Day 1 and Day 29	RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
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	Day 1 and Day 29	hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

Secondary Outcome Measures

Name	Time	Method
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	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
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	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
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	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
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	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
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	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

Trial Locations

Locations (17)

Velocity Clinical Research-Hallandale Beach- Site Number : 8400013; 🇺🇸 Hallandale Beach, Florida, United States

Advanced Clinical Research- Site Number : 8400005; 🇺🇸 Meridian, Idaho, United States

Meridian Clinical Research- Site Number : 8400007; 🇺🇸 Binghamton, New York, United States

Velocity Clinical Research- Site Number : 8400012; 🇺🇸 Cleveland, Ohio, United States

Coastal Carolina Research Center- Site Number : 8400001; 🇺🇸 North Charleston, South Carolina, United States

Charlottesville Medical Research Center Winding River - Site Number : 8400002; 🇺🇸 Charlottesville, Virginia, United States

Velocity Gardena Site Number : 8400011; 🇺🇸 Gardena, California, United States

Velocity Clinical Research, Sioux City Site Number : 8400017; 🇺🇸 Sioux City, Iowa, United States

Velocity Clinical Research- New Orleans Site Number : 8400016; 🇺🇸 New Orleans, Louisiana, United States

Investigational Site Number : 0360006; 🇦🇺 Blacktown, New South Wales, Australia

Investigational Site Number : 0360002; 🇦🇺 Botany, New South Wales, Australia

Investigational Site Number : 0360003; 🇦🇺 Kanwal, New South Wales, Australia

Investigational Site Number : 0360004; 🇦🇺 Sydney, New South Wales, Australia

Investigational Site Number : 0360008; 🇦🇺 Herston, Queensland, Australia

Investigational Site Number : 0360005; 🇦🇺 Morayfield, Queensland, Australia

Investigational Site Number : 0360001; 🇦🇺 Camberwell, Victoria, Australia

Investigational Site Number : 0360007; 🇦🇺 Canberra, Australia