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

NCT07734649 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: VCA23395U1111-1337-4718
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Immunization; Human Metapneumovirus Immunization; Healthy Volunteers

Keywords

RSV; HMPV

Outcome Measures

Primary Outcomes (10)

• RSV A serum nAb (neutralizing antibodies) titers

  nAb titers expressed as geometric mean titers (GMTs)

  At Day 1 and Day 29

• RSV B serum nAb titers

  nAb titers expressed as GMTs

  At Day 1 and Day 29

• HMPV A serum nAb titers

  nAb titers expressed as GMTs

  At Day 1 and Day 29

• HMPV B serum nAb titers

  nAb titers expressed as GMTs

  At Day 1 and Day 29

• Unsolicited systemic Adverse Events (AEs) that occur 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

  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

  Number of participants reporting unsolicited AEs

  For 28 days, including day of vaccination

• Presence of medically attended AEs (MAAEs)

  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)

  Number of participants reporting SAEs, fatal SAEs and AESIs

  Throughout the study (approximately 12 months)

• Presence of out-of-range biological test results

  Number of participants with biological safety assessment values out of normal range (including shift from baseline values)

  At Day 09

Secondary Outcomes (8)

• RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

  3, 6, 9, and 12-months post-vaccination

• RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

  3, 6, 9, and 12 months post-vaccination

• HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

  3, 6, 9, and 12 months post-vaccination

• HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

  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

  pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

Study Arms (11)

Group 1: RSV + HMPV Vaccine-Dose 1

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 2: RSV + HMPV Vaccine-Dose 2

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 3: RSV + HMPV Vaccine-Dose 3

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 4: RSV + HMPV Vaccine-Dose 4

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 5: RSV + HMPV Vaccine-Dose 5

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 6: RSV + HMPV Vaccine-Dose 6

EXPERIMENTAL

Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio

Biological: RSV+HMPV vaccine

Group 7: Control Vaccine 1

ACTIVE COMPARATOR

Participants will receive control vaccine 1

Biological: Control Vaccine 1

Group 8: Placebo

PLACEBO COMPARATOR

Participants will receive Placebo

Other: Placebo

Group 9: Control Vaccine 2

OTHER

Participants will receive control vaccine 2 at a predefined dose and antigen ratio

Biological: Control Vaccine 2

Group 10: Control Vaccine 3

OTHER

Participants will receive control vaccine 3 at a predefined dose

Biological: Control Vaccine 3

Group 11: Control Vaccine 4

OTHER

Participants will receive control vaccine 4 at a predefined dose

Biological: Control Vaccine 4

Interventions

RSV+HMPV vaccine BIOLOGICAL

RSV + HMPV Candidate Vaccine

Group 1: RSV + HMPV Vaccine-Dose 1; Group 2: RSV + HMPV Vaccine-Dose 2; Group 3: RSV + HMPV Vaccine-Dose 3; Group 4: RSV + HMPV Vaccine-Dose 4; Group 5: RSV + HMPV Vaccine-Dose 5; Group 6: RSV + HMPV Vaccine-Dose 6

Control Vaccine 3 BIOLOGICAL

Control Vaccine 3

Group 10: Control Vaccine 3

Control Vaccine 4 BIOLOGICAL

Control Vaccine 4

Group 11: Control Vaccine 4

Control Vaccine 2 BIOLOGICAL

Control Vaccine 2

Group 9: Control Vaccine 2

Placebo OTHER

Placebo

Group 8: Placebo

Control Vaccine 1 BIOLOGICAL

Control Vaccine 1

Group 7: Control Vaccine 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (17)

Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025

Gadsden, Alabama, 35901, United States

RECRUITING

Scottsdale Clinical Trials- Site Number : 8400011

Scottsdale, Arizona, 85260, United States

RECRUITING

Long Beach Research Institute- Site Number : 8400005

Long Beach, California, 90805, United States

RECRUITING

Alliance Clinical - San Diego- Site Number : 8400033

San Diego, California, 92120, United States

RECRUITING

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064

DeLand, Florida, 32720, United States

RECRUITING

Accel Research Sites - NeuroStudies- Site Number : 8400063

Decatur, Georgia, 30030, United States

RECRUITING

DM Clinical Research - Chicago- Site Number : 8400050

Melrose Park, Illinois, 60160, United States

RECRUITING

DM Clinical Research - Detroit- Site Number : 8400049

Southfield, Michigan, 48076, United States

RECRUITING

Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016

Lincoln, Nebraska, 68510, United States

RECRUITING

Alliance Clinical - Las Vegas- Site Number : 8400034

Las Vegas, Nevada, 89109, United States

RECRUITING

Hawthorne Health - Staten Island- Site Number : 8400026

Staten Island, New York, 10309, United States

RECRUITING

DM Clinical Research - Philadelphia- Site Number : 8400046

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Coastal Carolina Research Center - North Charleston- Site Number : 8400061

North Charleston, South Carolina, 29405, United States

RECRUITING

Velocity Clinical Research - Austin- Site Number : 8400013

Austin, Texas, 78759, United States

RECRUITING

DM Clinical Research - Sugar Land- Site Number : 8400048

Sugar Land, Texas, 77478, United States

RECRUITING

DM Clinical Research - Tomball- Site Number : 8400045

Tomball, Texas, 77375, United States

RECRUITING

Charlottesville Medical Research- Site Number : 8400062

Charlottesville, Virginia, 22911, United States

RECRUITING

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind: * Blinding for vaccine group assignment: participants, outcome assessors, investigators, site staff, laboratory personnel, Sponsor study staff. * No blinding for site staff who prepare and administer the study interventions. * Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohort.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): May 3, 2028
• Study Completion (Estimated): May 3, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (17)