Healthy Volunteers, Metapneumovirus Infection, Respiratory Syncytial Virus Infection
Conditions
Brief summary
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
Detailed description
Study duration per participant is approximately 6 months.
Interventions
BIOLOGICALRSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
BIOLOGICALRSV/hMPV mRNA LNP 2
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
BIOLOGICALRSV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
BIOLOGICALhMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
* Participants, Investigators and site staff remain blinded during study conduct, except dedicated study staff preparing/administering the study intervention. * Sponsor study staff will remain unblinded, except laboratory staff who handle primary/secondary endpoints
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Informed consent form (ICF) has been signed and dated
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. --The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 and Day 29 | hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination |
| Presence of serious adverse events (SAEs) | Throughout study (up to approximately 6 months) | Throughout study (up to approximately 6 months) |
| Presence of adverse events of special interest (AESIs) | Throughout study (up to approximately 6 months) | Number of participants experiencing AESIs |
| 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, including shift from baseline values) |
| 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 | Day 1 and Day 29 | RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination |
| 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 | Day 1 and Day 29 | RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination |
| Presence of unsolicited systemic immediate adverse events (AEs) | Within 30 minutes after vaccination | Number of participants experiencing immediate an immediate unsolicited systemic adverse event |
| 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, fatigue, myalgia, arthralgia and chills |
| Presence of unsolicited AEs | Within 28 days after vaccination | Number of participants experiencing unsolicited AEs |
| Presence of medically attended adverse events (MAAEs) | Throughout study (up to approximately 6 months) | Number of participants experiencing MAAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | Day 1, Day 29, Day 91 and Day 181 | RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination |
Countries
Australia, United States
Outcome results
None listed