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NCT Number: NCT07734649

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

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.

Recruiting

Interested in participating?

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hawthorne Health - Gadsden- Site Number : 8400025, Gadsden, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. RSV A serum nAb (neutralizing antibodies) titers

    Time frame: At Day 1 and Day 29

    nAb titers expressed as geometric mean titers (GMTs)

  2. RSV B serum nAb titers

    Time frame: At Day 1 and Day 29

    nAb titers expressed as GMTs

  3. HMPV A serum nAb titers

    Time frame: At Day 1 and Day 29

    nAb titers expressed as GMTs

  4. HMPV B serum nAb titers

    Time frame: At Day 1 and Day 29

    nAb titers expressed as GMTs

  5. 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

  6. 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
  7. Presence of Unsolicited AEs

    Time frame: For 28 days, including day of vaccination

    Number of participants reporting unsolicited AEs

  8. Presence of medically attended AEs (MAAEs)

    Time frame: 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)

    Time frame: Throughout the study (approximately 12 months)

    Number of participants reporting SAEs, fatal SAEs and AESIs

  10. 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)

Secondary outcomes

  1. 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)

  2. 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. 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

  4. 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

  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

    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)

  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

    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

  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)

    Time frame: 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)

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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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