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

NCT07734649
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
2,400
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Lead sponsor
Sanofi
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Start date
2026-07-22
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Number of sites
17
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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.
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Short title
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-05-03
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First posted
2026-07-29
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Registry last updated
2026-07-29
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Primary completion date
2028-05-03
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Start date
2026-07-22
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Participants
2,400
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Participant count basis
Estimated
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Planned participants
2,400
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Protocol amendments
0
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Number of sites
17
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07734649
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ClinicalTrials.gov ID
NCT07734649
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
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.
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. RSV A serum nAb (neutralizing antibodies) titers

    Timeframe: At Day 1 and Day 29

    nAb titers expressed as geometric mean titers (GMTs)

  2. RSV B serum nAb titers

    Timeframe: At Day 1 and Day 29

    nAb titers expressed as GMTs

  3. HMPV A serum nAb titers

    Timeframe: At Day 1 and Day 29

    nAb titers expressed as GMTs

  4. HMPV B serum nAb titers

    Timeframe: At Day 1 and Day 29

    nAb titers expressed as GMTs

  5. Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination

    Timeframe: Within 30 minutes after vaccination

    Number of participants reporting immediate unsolicited systemic AEs

  6. Presence of solicited injection site and systemic reactions

    Timeframe: 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

  7. Presence of Unsolicited AEs

    Timeframe: For 28 days, including day of vaccination

    Number of participants reporting unsolicited AEs

  8. Presence of medically attended AEs (MAAEs)

    Timeframe: Within 6 months after vaccination

    Number of participants reporting MAAEs

  9. Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)

    Timeframe: Throughout the study (approximately 12 months)

    Number of participants reporting SAEs, fatal SAEs and AESIs

  10. Presence of out-of-range biological test results

    Timeframe: At Day 09

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

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

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

    nAb titers expressed as geometric mean titers (GMTs)

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

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

    nAb titers expressed as GMTs

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

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

    nAb titers expressed as GMTs

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

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

    nAb titers expressed as GMTs

  5. 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

    Timeframe: 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)

  6. 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

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

    Ab concentration expressed as GMCs

  7. 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)

    Timeframe: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

  8. 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)

    Timeframe: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Healthy volunteers
Yes

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

  • 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-BarrĂ© 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.

Sources for eligibility
clinicaltrials.gov

  • Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025Gadsden, United StatesRecruiting
  • Scottsdale Clinical Trials- Site Number : 8400011Scottsdale, United StatesRecruiting
  • Long Beach Research Institute- Site Number : 8400005Long Beach, United StatesRecruiting
  • Alliance Clinical - San Diego- Site Number : 8400033San Diego, United StatesRecruiting
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064DeLand, United StatesRecruiting
  • Accel Research Sites - NeuroStudies- Site Number : 8400063Decatur, United StatesRecruiting
  • DM Clinical Research - Chicago- Site Number : 8400050Melrose Park, United StatesRecruiting
  • DM Clinical Research - Detroit- Site Number : 8400049Southfield, United StatesRecruiting
  • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016Lincoln, United StatesRecruiting
  • Alliance Clinical - Las Vegas- Site Number : 8400034Las Vegas, United StatesRecruiting
  • Hawthorne Health - Staten Island- Site Number : 8400026Staten Island, United StatesRecruiting
  • DM Clinical Research - Philadelphia- Site Number : 8400046Philadelphia, United StatesRecruiting
  • Coastal Carolina Research Center - North Charleston- Site Number : 8400061North Charleston, United StatesRecruiting
  • Velocity Clinical Research - Austin- Site Number : 8400013Austin, United StatesRecruiting
  • DM Clinical Research - Sugar Land- Site Number : 8400048Sugar Land, United StatesRecruiting
  • DM Clinical Research - Tomball- Site Number : 8400045Tomball, United StatesRecruiting
  • Charlottesville Medical Research- Site Number : 8400062Charlottesville, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1337-4718
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)