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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
865
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
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
Presence of unsolicited systemic adverse events (AEs)
Number of participants experienciing unsolicited systemic adverse events
Time frame: Within 30 minutes after vaccination
Presence of solicited injection site or systemic reactions
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Time frame: Within 7 days after vaccination
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Time frame: Within 28 days after vaccination
Presence of medically attended adverse events (MAAEs)
Number of participants experiencing MAAEs
Time frame: Within 28 days after vaccination
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs
Time frame: Month 12
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Time frame: Month 12
Presence of out-of-range biological test results
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
Time frame: Within 7 days after vaccination
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1
Nab titers pre-vaccination
Time frame: Day 1
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29
Nab titers post-vaccination
Time frame: Day 29
Presence of immediate unsolicited systemic AEs (Stage 1)
Number of participants experiencing immediate unsolicitied systemic AEs
Time frame: Within 30 minutes after vaccination
Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1)
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Time frame: Within 7 days after vaccination
Presence of unsolicited AEs post-booster vaccination (Stage 1)
Number of participants experiencing unsolicited AEs
Time frame: Within 28 days after vaccination
Presence of MAAEs (Stage 1)
Number of participants experiencing MAAEs
Time frame: Within 28 days after vaccination
Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1)
Number of participants experiencing SAEs
Time frame: Throughout the booster study, approximately 12 months
Presence of adverse events of special interest post-booster vaccination (Stage 1)
Number of participants experiencing AESIs
Time frame: Throughout the booster study, approximately 12 months
Presence of out-of-range biological test results post-booster vaccination (Stage 1)
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
Time frame: Within 7 days after vaccination
RSV-A serum nAb titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) (Stage 1)
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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
...and 23 more locations
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6 and Month 12
GMTs of serum anti-F immunoglobulin G (IgG) antibody (Ab) titers post-primary vaccination (Stage 1)
Serum anti-F IgG Ab titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6 and Month 12
GMTs of RSV-A serum nAb post-booster vaccination (Stage 1)
RSV-A serum nAb titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1)
Serum anti-F IgG Ab titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post- booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
GMTs of serum anti-F IgG Ab titers pre-vaccination (Stage 2)
Nab titers pre-primary vaccination
Time frame: Day 1
GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2)
Nab titers post-vaccination
Time frame: Day 29