mRNA Vaccine for Respiratory Syncytial Virus

Recruiting at 24 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sanofi Pasteur, a Sanofi Company

No Placebo Group

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

Treatment Details

Interventions

• hMPV mRNA LNP 1 (Cancer Vaccine)
• RSV/hMPV mRNA LNP 1 (Cancer Vaccine)
• RSV/hMPV mRNA LNP 2 (Cancer Vaccine)
• RSV mRNA LNP 1 (Cancer Vaccine)

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

Group I: hMPV mRNA / LNP 1 Group 6 Experimental Treatment 1 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 4 Experimental Treatment 1 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 7 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 5 Experimental Treatment 1 Intervention

Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences