The trial is taking place at:
S

Suncoast Research Associates, LLC | Miami, FL

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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

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Sanofi

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Respiratory Syncytial Virus Immunization

Treatments

Biological: RSV vaccine candidate formulation 2
Biological: RSV vaccine candiate formulation 1
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05639894
U1111-1271-1514 (Registry Identifier)
VAE00010
2023-505343-40 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment

865 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

865 participants in 10 patient groups, including a placebo group

Group 1: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Treatment:
Biological: RSV vaccine candiate formulation 1
Group 2: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Treatment:
Biological: RSV vaccine candidate formulation 2
Group 3: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Treatment:
Biological: RSV vaccine candiate formulation 1
Group 4: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Treatment:
Biological: RSV vaccine candidate formulation 2
Group 5: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Treatment:
Biological: RSV vaccine candiate formulation 1
Group 6: Sentinel and Main Cohorts (Stage 1)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Treatment:
Biological: RSV vaccine candidate formulation 2
Group 7: Main, Sentinel and Booster Cohorts (Stage 1)
Placebo Comparator group
Description:
1 injection of placebo via intramuscular injection
Treatment:
Other: Placebo
Group 0: Phase IIa/Dose-ranging (Stage 2)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Treatment:
Biological: RSV vaccine candiate formulation 1
Group 1: Phase IIa/Dose-ranging (Stage 2)
Experimental group
Description:
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Treatment:
Biological: RSV vaccine candidate formulation 2
Group 2: Phase 11a/Dose-ranging (Stage 2)
Placebo Comparator group
Description:
1 injection of placebo via intramuscular injection
Treatment:
Other: Placebo

Trial contacts and locations

37

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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