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

NCT07734649

RecruitingPhase 1, Phase 2

Sponsor: Sanofi

Conditions: Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization, Healthy Volunteers

Interventions: RSV+HMPV vaccine, Control Vaccine 3, Control Vaccine 4, Control Vaccine 2, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (17)

Gadsden, Alabama, United States
Scottsdale, Arizona, United States
Long Beach, California, United States
San Diego, California, United States
DeLand, Florida, United States
Decatur, Georgia, United States
Melrose Park, Illinois, United States
Southfield, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Staten Island, New York, United States
Philadelphia, Pennsylvania, United States
North Charleston, South Carolina, United States
Austin, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Charlottesville, Virginia, United States