Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Immunization

In brief

Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also incorporated a Stage 2 (Phase IIa, dose-ranging design) that included adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants were randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses were performed, minimally at D07 and D28.

Key facts

Study ID

NCT05639894

Run by

Sanofi Pasteur, a Sanofi Company

People needed

865

Starts

2022-11-17

Expected to finish

2025-05-02

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion
• Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion
• Stage 1 and Stage 2:
• Sentinel Cohort: A female participant was eligible to participate if she was not pregnant or breastfeeding and:
• Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile OR
• Was of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
• Main and Booster Cohorts: A female participant was eligible to participate if she was not pregnant or breastfeeding and:
• Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile.
• Able to attend all scheduled visits and to comply with all study procedures
• Informed consent form was been signed and dated

You may not qualify if…

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA COVID-19 vaccine
• History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
• Previous history of myocarditis, pericarditis, and/or myopericarditis
• Thrombocytopenia or bleeding disorder, contraindicating IM injection based on investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion
• Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test
• Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
• The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where it is running

• Optimal Research Alabama Site Number : 8400032 — Huntsville, Alabama, United States
• Aventiv Research Mesa Site Number : 8400020 — Mesa, Arizona, United States
• CVS Health - Peoria Site Number : 8400042 — Peoria, Arizona, United States
• CVS Health - Phoenix Site Number : 8400041 — Phoenix, Arizona, United States
• Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010 — La Mesa, California, United States
• Peninsula Research Associates Site Number : 8400013 — Rolling Hills Estates, California, United States
• CVS Health - Thousand Oaks Site Number : 8400043 — Thousand Oaks, California, United States
• Cenexel Research Centers of America Site Number : 8400024 — Hollywood, Florida, United States
• Suncoast Research Associates, LLC Site Number : 8400003 — Miami, Florida, United States
• Centricity Research - Georgia Site Number : 8400009 — Rincon, Georgia, United States
• AES Peoria Site Number : 8400030 — Peoria, Illinois, United States
• DM Clinical Research - Chicago Site Number : 8400027 — River Forest, Illinois, United States
• Be Well Clinical Studies Site Number : 8400036 — Lincoln, Nebraska, United States
• Velocity Clinical Research Site Number : 8400019 — Cincinnati, Ohio, United States
• Velocity Clinical Research Site Number : 8400017 — Cleveland, Ohio, United States
• Aventiv Research Columbus Site Number : 8400007 — Columbus, Ohio, United States
• Lynn Institute of Norman Site Number : 8400023 — Norman, Oklahoma, United States
• Velocity Clinical Research, Medford Site Number : 8400014 — Medford, Oregon, United States
• Velocity Clinical Research - Providence Site Number : 8400006 — East Greenwich, Rhode Island, United States
• Coastal Carolina Research Center Site Number : 8400015 — North Charleston, South Carolina, United States
• DM Clinical Research - CyFair Site Number : 8400025 — Houston, Texas, United States
• Be Well Clinical Studies -Round Rock Site Number : 8400038 — Round Rock, Texas, United States
• IMA Clinical Research-San Antonio Site Number : 8400039 — San Antonio, Texas, United States
• Martin Diagnostic Clinic Site Number : 8400026 — Tomball, Texas, United States
• Velocity Clinical Research Site Number : 8400018 — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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