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
NCT ID: NCT05639894
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
865 participants
INTERVENTIONAL
2022-11-17
2025-05-02
Brief Summary
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The purpose Stage 1 (Phase I/IIa) is 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 are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage will evaluate 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 also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes 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 will be randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed, minimally at D07 and D28. Additional analyses may be performed as data are available.
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Detailed Description
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The duration of each participant's participation is 12 months for the Sentinel and Main Cohorts, 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
* Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 12 months post-vaccination.
* Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
* Booster Cohort: 1 IM injection 12 months after the primary vaccination. Participants will be followed for 12 months after administration of the booster dose.
Stage 2:
The duration of each participant's participation is approximately 6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post vaccination
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
* Investigators, study staff who conduct the safety assessment, and the participant will not know which study intervention is administered
* Sponsor study staff and study staff preparing/administering the study interventions and not involved with the safety evaluation will know which study intervention is administered Main and Booster Cohorts in Stage 1 and Stage 2: Modified double-blind
* Investigators, study staff who conduct the safety assessment, and the participant will not know which study intervention is administered
* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered
Study Groups
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Group 1: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 2: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 3: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 4: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 5: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 6: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 7: Main, Sentinel and Booster Cohorts (Stage 1)
1 injection of placebo via intramuscular injection
Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Group 0: Phase IIa/Dose-ranging (Stage 2)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 1: Phase IIa/Dose-ranging (Stage 2)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Group 2: Phase 11a/Dose-ranging (Stage 2)
1 injection of placebo via intramuscular injection
Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Interventions
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RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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 is eligible to participate if she is not pregnant or breastfeeding and:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile OR
* Is 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 is eligible to participate if she is not pregnant or breastfeeding and:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be 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 has been signed and dated
Exclusion Criteria
* 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, is 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 any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
* Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
* Previous vaccination against RSV with an investigational vaccine
* 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 is not intended to contain all considerations relevant to a potential participation in a clinical trial.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Investigational Site Number : 0360003
Botany, New South Wales, Australia
Investigational Site Number : 0360002
Camberwell, Victoria, Australia
Investigational Site Number : 0360001
Southport, , Australia
Investigational Site Number : 6300004
Carolina, , Puerto Rico
Investigational Site Number : 6300003
Guayama, , Puerto Rico
Investigational Site Number : 6300005
Guaynabo, , Puerto Rico
Investigational Site Number : 6300001
San Juan, , Puerto Rico
Investigational Site Number : 6300002
San Juan, , Puerto Rico
Countries
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Other Identifiers
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U1111-1271-1514
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-505343-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAE00010
Identifier Type: -
Identifier Source: org_study_id
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