The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: * RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, * RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, * RSV mRNA / LNP 1 at 1 dose or, * hMPV mRNA / LNP 1 at 1 dose
Study duration per participant is approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
558
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Velocity Gardena Site Number : 8400011
Gardena, California, United States
Velocity Clinical Research-Hallandale Beach- Site Number : 8400013
Hallandale, Florida, United States
Advanced Clinical Research- Site Number : 8400005
Meridian, Idaho, United States
Velocity Clinical Research, Sioux City Site Number : 8400017
Sioux City, Iowa, United States
Velocity Clinical Research- New Orleans Site Number : 8400016
New Orleans, Louisiana, United States
Meridian Clinical Research- Site Number : 8400007
Binghamton, New York, United States
Velocity Clinical Research- Site Number : 8400012
Cleveland, Ohio, United States
Coastal Carolina Research Center- Site Number : 8400001
North Charleston, South Carolina, United States
Charlottesville Medical Research Center Winding River - Site Number : 8400002
Charlottesville, Virginia, United States
Investigational Site Number : 0360006
Blacktown, New South Wales, Australia
...and 7 more locations
Presence of unsolicited systemic immediate adverse events (AEs)
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
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, fatigue, 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: Throughout study (up to approximately 6 months)
Presence of serious adverse events (SAEs)
Throughout study (up to approximately 6 months)
Time frame: Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Time frame: Throughout study (up to approximately 6 months)
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, including shift from baseline values)
Time frame: Within 7 days after vaccination
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Time frame: Day 1 and Day 29
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Time frame: Day 1 and Day 29
hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
Time frame: Day 1 and Day 29
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Day 91 and Day 181
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Day 91 and Day 181
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Day 91 and Day 181
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Day 91 and Day 181
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Time frame: Day 1, Day 29, Day 91 and Day 181
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