Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

July 27, 2026 updated by: Sanofi

A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.

The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV [6 dose levels], placebo and 4 control groups).

The duration of the study will be approximately 12 months for each participant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • United States
    • Alabama
      • Gadsden, Alabama, United States, 35901
        • Recruiting
        • Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Scottsdale Clinical Trials- Site Number : 8400011
    • California
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute- Site Number : 8400005
      • San Diego, California, United States, 92120
        • Recruiting
        • Alliance Clinical - San Diego- Site Number : 8400033
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Accel Research Sites - NeuroStudies- Site Number : 8400063
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Recruiting
        • DM Clinical Research - Chicago- Site Number : 8400050
    • Michigan
      • Southfield, Michigan, United States, 48076
        • Recruiting
        • DM Clinical Research - Detroit- Site Number : 8400049
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Alliance Clinical - Las Vegas- Site Number : 8400034
    • New York
      • Staten Island, New York, United States, 10309
        • Recruiting
        • Hawthorne Health - Staten Island- Site Number : 8400026
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • DM Clinical Research - Philadelphia- Site Number : 8400046
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center - North Charleston- Site Number : 8400061
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Velocity Clinical Research - Austin- Site Number : 8400013
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • DM Clinical Research - Sugar Land- Site Number : 8400048
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research - Tomball- Site Number : 8400045
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • Charlottesville Medical Research- Site Number : 8400062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 60 years or older on the day of inclusion
  • Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Exclusion Criteria:

  • History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Previous history of Guillain-Barré Syndrome
  • Any vaccine given 4 weeks before or 4 weeks after study intervention
  • Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
  • Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
  • Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
  • Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: RSV + HMPV Vaccine-Dose 1
Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Experimental: Group 2: RSV + HMPV Vaccine-Dose 2
Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Experimental: Group 3: RSV + HMPV Vaccine-Dose 3
Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Experimental: Group 4: RSV + HMPV Vaccine-Dose 4
Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Experimental: Group 5: RSV + HMPV Vaccine-Dose 5
Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Experimental: Group 6: RSV + HMPV Vaccine-Dose 6
Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio
Biological: RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Active Comparator: Group 7: Control Vaccine 1
Participants will receive control vaccine 1
Biological: Control Vaccine 1
Control Vaccine 1
Placebo Comparator: Group 8: Placebo
Participants will receive Placebo
Other: Placebo
Placebo
Other: Group 9: Control Vaccine 2
Participants will receive control vaccine 2 at a predefined dose and antigen ratio
Biological: Control Vaccine 2
Control Vaccine 2
Other: Group 10: Control Vaccine 3
Participants will receive control vaccine 3 at a predefined dose
Biological: Control Vaccine 3
Control Vaccine 3
Other: Group 11: Control Vaccine 4
Participants will receive control vaccine 4 at a predefined dose
Biological: Control Vaccine 4
Control Vaccine 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV A serum nAb (neutralizing antibodies) titers
Time Frame: At Day 1 and Day 29
nAb titers expressed as geometric mean titers (GMTs)
At Day 1 and Day 29
RSV B serum nAb titers
Time Frame: At Day 1 and Day 29
nAb titers expressed as GMTs
At Day 1 and Day 29
HMPV A serum nAb titers
Time Frame: At Day 1 and Day 29
nAb titers expressed as GMTs
At Day 1 and Day 29
HMPV B serum nAb titers
Time Frame: At Day 1 and Day 29
nAb titers expressed as GMTs
At Day 1 and Day 29
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination
Time Frame: Within 30 minutes after vaccination
Number of participants reporting immediate unsolicited systemic AEs
Within 30 minutes after vaccination
Presence of solicited injection site and systemic reactions
Time Frame: For 8 days, including the day of vaccination

Number of participants reporting:

  • injection site reactions: pain, erythema and swelling
  • systemic reactions: fever, headache, fatigue and myalgia
For 8 days, including the day of vaccination
Presence of Unsolicited AEs
Time Frame: For 28 days, including day of vaccination
Number of participants reporting unsolicited AEs
For 28 days, including day of vaccination
Presence of medically attended AEs (MAAEs)
Time Frame: Within 6 months after vaccination
Number of participants reporting MAAEs
Within 6 months after vaccination
Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)
Time Frame: Throughout the study (approximately 12 months)
Number of participants reporting SAEs, fatal SAEs and AESIs
Throughout the study (approximately 12 months)
Presence of out-of-range biological test results
Time Frame: At Day 09
Number of participants with biological safety assessment values out of normal range (including shift from baseline values)
At Day 09

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination
Time Frame: 3, 6, 9, and 12-months post-vaccination
nAb titers expressed as geometric mean titers (GMTs)
3, 6, 9, and 12-months post-vaccination
RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination
Time Frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
3, 6, 9, and 12 months post-vaccination
HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination
Time Frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
3, 6, 9, and 12 months post-vaccination
HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination
Time Frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
3, 6, 9, and 12 months post-vaccination
Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Time Frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Ab concentration expressed as geometric mean concentrations (GMCs)
pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Time Frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Ab concentration expressed as GMCs
pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)
Time Frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)
Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)
Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)
Time Frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)
Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2026

Primary Completion (Estimated)

May 3, 2028

Study Completion (Estimated)

May 3, 2028

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VCA23395
  • U1111-1337-4718 (Other Grant/Funding Number: WHO 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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