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
Completed · Phase 1 · NCT06237296
Conditions: Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection
At a glance
- Research payments reported, 2025
- $431,961
- U.S. investigators named
- 9
- Sites paid
- 4
- Planned or actual enrollment
- 558
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- RSV/hMPV mRNA LNP 1 (biological), RSV/hMPV mRNA LNP 2 (biological), RSV mRNA LNP 1 (biological), hMPV mRNA LNP 1 (biological)
- Dates
- Started 2024-01-23; completion 2025-02-11
- Results posted
- Not yet
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 / …
From ClinicalTrials.gov, last updated 2025-09-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $431,961 in research payments for this study in 2025 (61 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Mark T. Leibowitz, M.D. Internal Medicine · Long Beach, CA
- Julio C. Vijil JR., MD, MPH Nephrology (Kidney) · Plantation, FL
- Nicholas C. Bechtold, D.O. Family Medicine · Sioux City, IA
- Mark A. Turner, MD Family Medicine · Meridian, ID
- Scott P. Striplin, M.D. OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Frank Eder, MD Family Medicine · Binghamton, NY
- Margaret E. Rhee, MD OB-GYN (Obstetrics & Gynecology) · Akron, OH
- Kelly N. Morales, MD Family Medicine · North Charleston, SC
- James R. Clark, MD Internal Medicine · Charlottesville, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research,inc $167,560
- Coastal Carolina Research Center,incorporation $157,237
- Velocity Clinical Research $93,764
- Charlottesville Medical Research Center,llc $13,401
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.