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

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.

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers; Respiratory Syncytial Virus Infection; Metapneumovirus Infection
• Intervention / Treatment: Biological: RSV/hMPV mRNA LNP 1; Biological: RSV/hMPV mRNA LNP 2; Biological: RSV mRNA LNP 1; Biological: hMPV mRNA LNP 1

Detailed Description

Study duration per participant is approximately 6 months.

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Canberra, Australia, 2617
    • Investigational Site Number : 0360007
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Investigational Site Number : 0360006
    • Botany, New South Wales, Australia, 2019
      • Investigational Site Number : 0360002
    • Kanwal, New South Wales, Australia, 2259
      • Investigational Site Number : 0360003
    • Sydney, New South Wales, Australia, 2035
      • Investigational Site Number : 0360004
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Investigational Site Number : 0360008
    • Morayfield, Queensland, Australia, 4506
      • Investigational Site Number : 0360005
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Investigational Site Number : 0360001
• United States
  • California
    • Gardena, California, United States, 90247
      • Velocity Gardena Site Number : 8400011
  • Florida
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research-Hallandale Beach- Site Number : 8400013
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research- Site Number : 8400005
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City Site Number : 8400017
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Velocity Clinical Research- New Orleans Site Number : 8400016
  • New York
    • Binghamton, New York, United States, 13905
      • Meridian Clinical Research- Site Number : 8400007
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research- Site Number : 8400012
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center- Site Number : 8400001
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center Winding River - Site Number : 8400002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV/hMPV mRNA / LNP 1 Group 1; Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.	Biological: RSV/hMPV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 2; Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.	Biological: RSV/hMPV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 3; Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.	Biological: RSV/hMPV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 2 Group 4; Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.	Biological: RSV/hMPV mRNA LNP 2; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV mRNA / LNP 1 Group 5; Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.	Biological: RSV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: hMPV mRNA / LNP 1 Group 6; Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.	Biological: hMPV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: RSV/hMPV mRNA / LNP 1 Group 7; Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.	Biological: RSV/hMPV mRNA LNP 1; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of unsolicited AEs	Number of participants experiencing unsolicited AEs	Within 28 days after vaccination
Presence of out-of-range biological test results	Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)	Within 7 days after vaccination
Presence of unsolicited systemic immediate adverse events (AEs)	Number of participants experiencing immediate an immediate unsolicited systemic adverse event	Within 30 minutes after vaccination
Presence of solicited injection site or systemic reactions	Number of participants reporting: injection site reactions: pain, erythema and swelling; systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills	Within 7 days after vaccination
Presence of medically attended adverse events (MAAEs)	Number of participants experiencing MAAEs	Throughout study (up to approximately 6 months)
Presence of serious adverse events (SAEs)	Throughout study (up to approximately 6 months)	Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Throughout study (up to approximately 6 months)
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	RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination	Day 1 and Day 29
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	RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination	Day 1 and Day 29
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	hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination	Day 1 and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination	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 in the monovalent RSV formulation	RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination	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 in the monovalent RSV formulation	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	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 in the monovalent hMPV formulations	hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination	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 in the monovalent hMPV formulations	hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination	Day 1, Day 29, Day 91 and Day 181

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• VAV00027 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: VAV00027 (Other Identifier: Sanofi Identifier); U1111-1295-2931 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No