558 Participants Needed

mRNA Vaccine for Respiratory Syncytial Virus

Recruiting at 24 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sanofi Pasteur, a Sanofi Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for healthy adults aged 18-49 and those 60 or older. Participants must have signed a consent form. They can't join if they have any health issues that might affect the study's results, as judged by the study leader.

Inclusion Criteria

Informed consent form (ICF) has been signed and dated

Exclusion Criteria

Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of the RSV/hMPV mRNA vaccine candidate at various doses

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including serum neutralizing antibody titers and adverse events

6 months
Multiple visits (in-person and virtual) at Day 29, Day 91, and Day 181

Treatment Details

Interventions

  • hMPV mRNA LNP 1
  • RSV/hMPV mRNA LNP 1
  • RSV/hMPV mRNA LNP 2
  • RSV mRNA LNP 1
Trial Overview The trial tests an experimental mRNA vaccine designed to prevent lung infections caused by two viruses: RSV and hMPV. Participants will receive one intramuscular injection of various doses of this vaccine in different formulations.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: hMPV mRNA / LNP 1 Group 6Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.
Group II: RSV/hMPV mRNA / LNP 2 Group 4Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.
Group III: RSV/hMPV mRNA / LNP 1 Group 7Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.
Group IV: RSV/hMPV mRNA / LNP 1 Group 3Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.
Group V: RSV/hMPV mRNA / LNP 1 Group 2Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.
Group VI: RSV/hMPV mRNA / LNP 1 Group 1Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.
Group VII: RSV mRNA / LNP 1 Group 5Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials
429
Recruited
6,140,000+
Paul Hudson profile image

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe profile image

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security