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
Investigating the Safety and Immune Response of an RSV Vaccine
Study Overview
Brief Summary of Stage 1:
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.
Study Details
Stage 1:
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
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory Syncytial Virus Immunization
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- 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 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 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, 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.
This study investigates the safety and immunogenicity of an investigational vaccine for Respiratory Syncytial Virus (RSV) in healthy adults. The study is divided into two stages. Stage 1 involves participants aged 18 to 50 years and those 60 years and older, receiving one of three dose levels of the vaccine formulated with two different lipid nanoparticles (LNPs). The aim is to assess safety and immune response across these dose levels. A booster dose will be given to a subset of participants 12 months after the initial vaccination to further evaluate safety and immune response.
In Stage 2, the study focuses on adults aged 60 years and older, assessing different doses of the RSV vaccine using one type of LNP. Participants will be randomly assigned to receive either the vaccine or a placebo. Safety evaluations will occur at specific intervals, such as Day 7 and Day 28 after vaccination, with further analyses as needed. The placebo used in this study is an inactive substance that looks like the investigational vaccine but does not contain any medicine.
- Who can participate: Participants aged 18 to 50 years can join Stage 1, and those 60 years and older can join both stages. Participants must meet specific health and reproductive criteria.
- Study details: Participants will receive a single intramuscular injection of the investigational RSV vaccine or placebo. The study involves monitoring participants for safety and immune response after vaccination.
- Study Timelines: The study will last 12 months for Stage 1 and approximately 6 months for Stage 2.
