Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older (NCT07734649)
A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
🩺 Plain-English Summary (8th-Grade Level)
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (11 items).
Location: Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025 — Gadsden, Alabama
Age range: 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome
- Any vaccine given 4 weeks before or 4 weeks after study intervention
- Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
- Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
- Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
- Any screening laboratory parameter with laboratory abnormality \> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (17 Sites)
- Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025 — Gadsden, Alabama
- Scottsdale Clinical Trials- Site Number : 8400011 — Scottsdale, Arizona
- Long Beach Research Institute- Site Number : 8400005 — Long Beach, California
- Alliance Clinical - San Diego- Site Number : 8400033 — San Diego, California
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064 — DeLand, Florida
- Accel Research Sites - NeuroStudies- Site Number : 8400063 — Decatur, Georgia
- DM Clinical Research - Chicago- Site Number : 8400050 — Melrose Park, Illinois
- DM Clinical Research - Detroit- Site Number : 8400049 — Southfield, Michigan
- Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016 — Lincoln, Nebraska
- Alliance Clinical - Las Vegas- Site Number : 8400034 — Las Vegas, Nevada
- Hawthorne Health - Staten Island- Site Number : 8400026 — Staten Island, New York
- DM Clinical Research - Philadelphia- Site Number : 8400046 — Philadelphia, Pennsylvania
- Coastal Carolina Research Center - North Charleston- Site Number : 8400061 — North Charleston, South Carolina
- Velocity Clinical Research - Austin- Site Number : 8400013 — Austin, Texas
- DM Clinical Research - Sugar Land- Site Number : 8400048 — Sugar Land, Texas
- DM Clinical Research - Tomball- Site Number : 8400045 — Tomball, Texas
- Charlottesville Medical Research- Site Number : 8400062 — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: Contact-US@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Respiratory Syncytial Virus Immunization clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.