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
- 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
- Short title
- 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.
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-02-11
- First posted
- 2024-02-01
- Registry last updated
- 2025-09-11
- Primary completion date
- 2025-02-11
- Start date
- 2024-01-23
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06237296
- ClinicalTrials.gov ID
- NCT06237296
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- 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
- Masked roles
- Participants, Care providers, Investigators
Presence of unsolicited systemic immediate adverse events (AEs)
Timeframe: Within 30 minutes after vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of solicited injection site or systemic reactions
Timeframe: 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
Timeframe: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs)
Timeframe: Throughout study (up to approximately 6 months)
Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs)
Timeframe: Throughout study (up to approximately 6 months)
Throughout study (up to approximately 6 months)
Presence of adverse events of special interest (AESIs)
Timeframe: Throughout study (up to approximately 6 months)
Number of participants experiencing AESIs
Presence of out-of-range biological test results
Timeframe: 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
Timeframe: 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
Timeframe: Day 1 and Day 29
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination
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
hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) 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
Timeframe: 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
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
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
Timeframe: 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
Timeframe: 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
Timeframe: 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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
-Informed consent form (ICF) has been signed and dated
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.
- Velocity Gardena Site Number : 8400011Gardena, United States
- Velocity Clinical Research-Hallandale Beach- Site Number : 8400013Hallandale, United States
- Advanced Clinical Research- Site Number : 8400005Meridian, United States
- Velocity Clinical Research, Sioux City Site Number : 8400017Sioux City, United States
- Velocity Clinical Research- New Orleans Site Number : 8400016New Orleans, United States
- Meridian Clinical Research- Site Number : 8400007Binghamton, United States
- Velocity Clinical Research- Site Number : 8400012Cleveland, United States
- Coastal Carolina Research Center- Site Number : 8400001North Charleston, United States
- Charlottesville Medical Research Center Winding River - Site Number : 8400002Charlottesville, United States
- Investigational Site Number : 0360006Blacktown, Australia
- Investigational Site Number : 0360002Botany, Australia
- Investigational Site Number : 0360003Kanwal, Australia
- Investigational Site Number : 0360004Sydney, Australia
- Investigational Site Number : 0360008Herston, Australia
- Investigational Site Number : 0360005Morayfield, Australia
- Investigational Site Number : 0360001Camberwell, Australia
- Investigational Site Number : 0360007Canberra, Australia
- U1111-1295-2931
- VAV00027
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Respiratory syncytial virus infectious disease Primary condition