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
- Conditions
- Respiratory Syncytial Virus Immunization
- Interventions
- Biological: RSV vaccine candiate formulation 1Other: PlaceboBiological: RSV vaccine candidate formulation 2
- Registration Number
- NCT05639894
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 865
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: Sentinel and Main Cohorts (Stage 1) RSV vaccine candiate formulation 1 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection Group 5: Sentinel and Main Cohorts (Stage 1) RSV vaccine candiate formulation 1 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection Group 7: Main, Sentinel and Booster Cohorts (Stage 1) Placebo 1 injection of placebo via intramuscular injection Group 4: Sentinel and Main Cohorts (Stage 1) RSV vaccine candidate formulation 2 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection Group 0: Phase IIa/Dose-ranging (Stage 2) RSV vaccine candiate formulation 1 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection Group 1: Phase IIa/Dose-ranging (Stage 2) RSV vaccine candidate formulation 2 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection Group 2: Phase 11a/Dose-ranging (Stage 2) Placebo 1 injection of placebo via intramuscular injection Group 6: Sentinel and Main Cohorts (Stage 1) RSV vaccine candidate formulation 2 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection Group 1: Sentinel and Main Cohorts (Stage 1) RSV vaccine candiate formulation 1 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection Group 2: Sentinel and Main Cohorts (Stage 1) RSV vaccine candidate formulation 2 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
- Primary Outcome Measures
Name Time Method Presence of unsolicited systemic adverse events (AEs) Within 30 minutes after vaccination Number of participants experienciing unsolicited systemic adverse events
Presence of solicited injection site or systemic reactions Within 7 days after vaccination Number of participants reporting:
* injection site reactions: pain, erythema and swelling
* systemic reactions: fever, headache, malaise, myalgia, arthralgia and chillsPresence of unsolicited AEs Within 28 days after vaccination Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs) Within 28 days after vaccination Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs) Month 12 Number of participants experiencing SAEs
Presence of out-of-range biological test results Within 7 days after vaccination Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1 Day 1 Nab titers pre-vaccination
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29 Day 29 Nab titers post-vaccination
Presence of adverse events of special interest (AESIs) Month 12 Number of participants experiencing AESIs
- Secondary Outcome Measures
Name Time Method Presence of immediate unsolicited systemic AEs (Stage 1) Within 30 minutes after vaccination Number of participants experiencing immediate unsolicitied systemic AEs
Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1) Within 7 days after vaccination Number of participants reporting:
* injection site reactions: pain, erythema and swelling
* systemic reactions: fever, headache, malaise, myalgia, arthralgia and chillsPresence of unsolicited AEs post-booster vaccination (Stage 1) Within 28 days after vaccination Number of participants experiencing unsolicited AEs
Presence of MAAEs (Stage 1) Within 28 days after vaccination Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1) Throughout the booster study, approximately 12 months Number of participants experiencing SAEs
Presence of adverse events of special interest post-booster vaccination (Stage 1) Throughout the booster study, approximately 12 months Number of participants experiencing AESIs
Presence of out-of-range biological test results post-booster vaccination (Stage 1) Within 7 days after vaccination Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
RSV-A serum nAb titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) (Stage 1) Day 1, Day 29, Month 3, Month 6 and Month 12 RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
GMTs of serum anti-F immunoglobulin G (IgG) antibody (Ab) titers post-primary vaccination (Stage 1) Day 1, Day 29, Month 3, Month 6 and Month 12 Serum anti-F IgG Ab titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2) Day 29 Nab titers post-vaccination
GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1) Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster Serum anti-F IgG Ab titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post- booster vaccination
GMTs of RSV-A serum nAb post-booster vaccination (Stage 1) Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster RSV-A serum nAb titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post-booster vaccination
GMTs of serum anti-F IgG Ab titers pre-vaccination (Stage 2) Day 1 Nab titers pre-primary vaccination
Trial Locations
- Locations (33)
Cenexel Research Centers of America Site Number : 8400024
🇺🇸Hollywood, Florida, United States
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
Suncoast Research Associates, LLC Site Number : 8400003
🇺🇸Miami, Florida, United States
Centricity Research - Georgia Site Number : 8400009
🇺🇸Rincon, Georgia, United States
Scroll for more (23 remaining)Cenexel Research Centers of America Site Number : 8400024🇺🇸Hollywood, Florida, United States