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
Public ClinicalTrials.gov record NCT06686654. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Randomized, Observer-blind, Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an hMPV/RSV mRNA Vaccine Candidate in Adult Participants Aged 60 Years and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06686654
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,530 participants
Conditions and interventions
Interventions
- Investigational hMPV/RSV vaccine Biological
- Investigational hMPV vaccine (monovalent) Biological
- Investigational RSV vaccine (monovalent) Biological
- Licensed RSV Vaccine Biological
- Placebo Biological
- Investigational RSV+hMPV vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2024
- Primary completion
- Jan 17, 2027
- Completion
- Jan 17, 2027
- Last update posted
- Dec 10, 2025
2024 – 2027
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research, Phoenix- Site Number : 8400025 | Phoenix | Arizona | 85006 | — |
| CenExel CNS-Garden Grove- Site Number : 8400017 | Garden Grove | California | 92845 | — |
| National Research Institute - Gardena- Site Number : 8400005 | Gardena | California | 90247 | — |
| National Research Institute - Huntington Park- Site Number : 8400014 | Huntington Park | California | 90255 | — |
| Velocity Clinical Research - San Diego- Site Number : 8400008 | La Mesa | California | 91942 | — |
| Velocity Clinical Research Los Angeles- Site Number : 8400013 | Los Angeles | California | 90017 | — |
| National Research Institute - Panorama City- Site Number : 8400012 | Los Angeles | California | 91402 | — |
| Providence Clinical Research - North Hollywood- Site Number : 8400018 | North Hollywood | California | 91606 | — |
| Peninsula Research Associates- Site Number : 8400002 | Rolling Hills Estates | California | 90274 | — |
| Velocity Clinical Research - Denver- Site Number : 8400016 | Englewood | Colorado | 80110 | — |
| Velocity Clinical Research - Washington DC- Site Number : 8400007 | Washington D.C. | District of Columbia | 20016 | — |
| Velocity Clinical Research - Hallandale Beach- Site Number : 8400022 | Hallandale | Florida | 33009 | — |
| Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001 | Miami | Florida | 33173 | — |
| Velocity Clinical Research - Meridian- Site Number : 8400003 | Meridian | Idaho | 83642 | — |
| Velocity Clinical Research - Kansas City- Site Number : 8400015 | Overland Park | Kansas | 66210 | — |
| Velocity Clinical Research - Rockville- Site Number : 8400011 | Rockville | Maryland | 20854 | — |
| Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023 | Lincoln | Nebraska | 68510 | — |
| Velocity Clinical Research - Omaha- Site Number : 8400006 | Omaha | Nebraska | 68134 | — |
| Velocity Clinical Research - Springdale- Site Number : 8400004 | Cincinnati | Ohio | 45246 | — |
| Velocity Clinical Research - Medford- Site Number : 8400024 | Medford | Oregon | 97504 | — |
| Velocity Clinical Research - Austin- Site Number : 8400020 | Cedar Park | Texas | 78613 | — |
| Velocity Clinical Research - Salt Lake City- Site Number : 8400010 | West Jordan | Utah | 84088 | — |
| Velocity Clinical Research - Hampton- Site Number : 8400026 | Hampton | Virginia | 23666 | — |
| Velocity Clinical Research - Seattle- Site Number : 8400019 | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06686654, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06686654 live on ClinicalTrials.gov.