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

Part of paid clinical trials in Gadsden, Alabama.

Sponsor
Sanofi
Study ID
NCT07734649
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteers
  • Human Metapneumovirus Immunization
  • Respiratory Syncytial Virus Immunization

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • RSV+HMPV vaccine — BIOLOGICAL
    RSV + HMPV Candidate Vaccine
  • Control Vaccine 3 — BIOLOGICAL
    Control Vaccine 3
  • Control Vaccine 4 — BIOLOGICAL
    Control Vaccine 4
  • Control Vaccine 2 — BIOLOGICAL
    Control Vaccine 2
  • Placebo — OTHER
    Placebo
  • Control Vaccine 1 — BIOLOGICAL
    Control Vaccine 1

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 22, 2026
Status verified
Jul 2026
Primary completion
May 3, 2028
Completion
May 3, 2028

Study Design

Enrollment
2,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

RSV A serum nAb (neutralizing antibodies) titers [ Time Frame: At Day 1 and Day 29 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (17)

FacilityCityStateZIPSite coordinators
Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025GadsdenAlabama35901-
Scottsdale Clinical Trials- Site Number : 8400011ScottsdaleArizona85260-
Long Beach Research Institute- Site Number : 8400005Long BeachCalifornia90805-
Alliance Clinical - San Diego- Site Number : 8400033San DiegoCalifornia92120-
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064DeLandFlorida32720-
Accel Research Sites - NeuroStudies- Site Number : 8400063DecaturGeorgia30030-
DM Clinical Research - Chicago- Site Number : 8400050Melrose ParkIllinois60160-
DM Clinical Research - Detroit- Site Number : 8400049SouthfieldMichigan48076-
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016LincolnNebraska68510-
Alliance Clinical - Las Vegas- Site Number : 8400034Las VegasNevada89109-
Hawthorne Health - Staten Island- Site Number : 8400026Staten IslandNew York10309-
DM Clinical Research - Philadelphia- Site Number : 8400046PhiladelphiaPennsylvania19107-
Coastal Carolina Research Center - North Charleston- Site Number : 8400061North CharlestonSouth Carolina29405-
Velocity Clinical Research - Austin- Site Number : 8400013AustinTexas78759-
DM Clinical Research - Sugar Land- Site Number : 8400048Sugar LandTexas77478-
DM Clinical Research - Tomball- Site Number : 8400045TomballTexas77375-
Charlottesville Medical Research- Site Number : 8400062CharlottesvilleVirginia22911-

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