Clinical trial NCT06237296: Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
Official title: A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infection
Healthy Volunteers
Metapneumovirus Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of unsolicited systemic immediate adverse events (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Presence of solicited injection site or systemic reactions
timeFrame: Within 7 days after vaccination
measure: Presence of unsolicited AEs
timeFrame: Within 28 days after vaccination
measure: Presence of medically attended adverse events (MAAEs)
timeFrame: Throughout study (up to approximately 6 months)
measure: Presence of serious adverse events (SAEs)
timeFrame: Throughout study (up to approximately 6 months)
measure: Presence of adverse events of special interest (AESIs)
timeFrame: Throughout study (up to approximately 6 months)
measure: Presence of out-of-range biological test results
timeFrame: Within 7 days after vaccination
measure: 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
timeFrame: Day 1 and Day 29
measure: 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
timeFrame: Day 1 and Day 29
measure: 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
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: 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
timeFrame: Day 1, Day 29, Day 91 and Day 181
measure: 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
timeFrame: Day 1, Day 29, Day 91 and Day 181
measure: 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
timeFrame: Day 1, Day 29, Day 91 and Day 181
measure: 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
timeFrame: Day 1, Day 29, Day 91 and Day 181
measure: 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
timeFrame: Day 1, Day 29, Day 91 and Day 181
Other outcomes:
Locations:
city: Gardena
country: United States
facility: Velocity Gardena Site Number : 8400011
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research-Hallandale Beach- Site Number : 8400013
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research- Site Number : 8400005
state: Idaho
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City Site Number : 8400017
state: Iowa
city: New Orleans
country: United States
facility: Velocity Clinical Research- New Orleans Site Number : 8400016
state: Louisiana
city: Binghamton
country: United States
facility: Meridian Clinical Research- Site Number : 8400007
state: New York
city: Cleveland
country: United States
facility: Velocity Clinical Research- Site Number : 8400012
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center- Site Number : 8400001
state: South Carolina
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center Winding River - Site Number : 8400002
state: Virginia
city: Blacktown
country: Australia
facility: Investigational Site Number : 0360006
state: New South Wales
city: Botany
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Kanwal
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Sydney
country: Australia
facility: Investigational Site Number : 0360004
state: New South Wales
city: Herston
country: Australia
facility: Investigational Site Number : 0360008
state: Queensland
city: Morayfield
country: Australia
facility: Investigational Site Number : 0360005
state: Queensland
city: Camberwell
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Canberra
country: Australia
facility: Investigational Site Number : 0360007
Study officials:
References: