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ACTIVE NOT RECRUITING Phase 1

Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older

NCT06686654 · View on ClinicalTrials.gov ↗

Study Summary

The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older. The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate). Overall, the study is designed to address the following goals: * Assess the safety profile of the candidate formulations. * Describe the immunogenicity profile of the candidate formulations. * Select the vaccine formulations (dose) for future development. * Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine. The study duration is as follows: -Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort Treatment duration: * Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination * Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination * Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination * Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Investigational hMPV/RSV vaccine
  • BIOLOGICAL Investigational hMPV vaccine (monovalent)
  • BIOLOGICAL Investigational RSV vaccine (monovalent)
  • BIOLOGICAL Licensed RSV Vaccine

Study Locations (20)

California

  • CenExel CNS-Garden Grove- Site Number : 8400017 — Garden Grove
  • National Research Institute - Gardena- Site Number : 8400005 — Gardena
  • National Research Institute - Huntington Park- Site Number : 8400014 — Huntington Park
  • Velocity Clinical Research - San Diego- Site Number : 8400008 — La Mesa
  • Velocity Clinical Research Los Angeles- Site Number : 8400013 — Los Angeles
  • National Research Institute - Panorama City- Site Number : 8400012 — Los Angeles
  • Providence Clinical Research - North Hollywood- Site Number : 8400018 — North Hollywood
  • Peninsula Research Associates- Site Number : 8400002 — Rolling Hills Estates

Florida

  • Velocity Clinical Research - Hallandale Beach- Site Number : 8400022 — Hallandale
  • Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001 — Miami

Nebraska

  • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023 — Lincoln
  • Velocity Clinical Research - Omaha- Site Number : 8400006 — Omaha

Arizona

  • Velocity Clinical Research, Phoenix- Site Number : 8400025 — Phoenix

Colorado

  • Velocity Clinical Research - Denver- Site Number : 8400016 — Englewood

District of Columbia

  • Velocity Clinical Research - Washington DC- Site Number : 8400007 — Washington D.C.

Idaho

  • Velocity Clinical Research - Meridian- Site Number : 8400003 — Meridian

Kansas

  • Velocity Clinical Research - Kansas City- Site Number : 8400015 — Overland Park

Trial Details

FieldValue
Enrollment Target 1,530 participants
Start Date 2024-11-11
Est. Completion 2027-01-18
Phase Phase 1

Sponsor

Sanofi Pasteur, a Sanofi Company

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06686654

The ClinicalTrials.gov registry entry for NCT06686654 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Human Metapneumovirus Immunization appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06686654 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06686654 about?

NCT06686654 is a clinical study titled "Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older". The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respira...

What is the current status of trial NCT06686654?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1,530 participants. The study started on 2024-11-11. Estimated completion is 2027-01-18.

What conditions does trial NCT06686654 study?

This clinical trial studies the following conditions: Human Metapneumovirus Immunization, Respiratory Syncytial Virus Immunization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06686654?

The interventions under investigation include: Placebo (BIOLOGICAL), Investigational hMPV/RSV vaccine (BIOLOGICAL), Investigational hMPV vaccine (monovalent) (BIOLOGICAL), Investigational RSV vaccine (monovalent) (BIOLOGICAL), Licensed RSV Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06686654?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06686654 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial