Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Public ClinicalTrials.gov record NCT05639894. 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 I/IIa, Randomized, Placebo-controlled Multi-arm Dose-finding Study to Evaluate the Safety and Immunogenicity of a RSV Vaccine Candidate in Adult Participants 18 to 50 Years of Age in Phase I, and 60 Years and Older in Phase IIa
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also incorporated a Stage 2 (Phase IIa, dose-ranging design) that included adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants were randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses were performed, minimally at D07 and D28.
Study identification
- NCT ID
- NCT05639894
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 865 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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 17, 2022 (Actual)
- Primary completion
- May 2, 2025 (Actual)
- Completion
- May 2, 2025 (Actual)
- Last update posted
- Aug 5, 2026
2022 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Research Alabama Site Number : 8400032 | Huntsville | Alabama | 35802 | — |
| Aventiv Research Mesa Site Number : 8400020 | Mesa | Arizona | 85210 | — |
| CVS Health - Peoria Site Number : 8400042 | Peoria | Arizona | 85381 | — |
| CVS Health - Phoenix Site Number : 8400041 | Phoenix | Arizona | 85019 | — |
| Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010 | La Mesa | California | 91942 | — |
| Peninsula Research Associates Site Number : 8400013 | Rolling Hills Estates | California | 90274 | — |
| CVS Health - Thousand Oaks Site Number : 8400043 | Thousand Oaks | California | 91361 | — |
| Cenexel Research Centers of America Site Number : 8400024 | Hollywood | Florida | 33024 | — |
| Suncoast Research Associates, LLC Site Number : 8400003 | Miami | Florida | 33173 | — |
| Centricity Research - Georgia Site Number : 8400009 | Rincon | Georgia | 31326 | — |
| AES Peoria Site Number : 8400030 | Peoria | Illinois | 61614 | — |
| DM Clinical Research - Chicago Site Number : 8400027 | River Forest | Illinois | 60305 | — |
| Be Well Clinical Studies Site Number : 8400036 | Lincoln | Nebraska | 68516 | — |
| Velocity Clinical Research Site Number : 8400019 | Cincinnati | Ohio | 45242 | — |
| Velocity Clinical Research Site Number : 8400017 | Cleveland | Ohio | 44122 | — |
| Aventiv Research Columbus Site Number : 8400007 | Columbus | Ohio | 43213 | — |
| Lynn Institute of Norman Site Number : 8400023 | Norman | Oklahoma | 73072 | — |
| Velocity Clinical Research, Medford Site Number : 8400014 | Medford | Oregon | 97504 | — |
| Velocity Clinical Research - Providence Site Number : 8400006 | East Greenwich | Rhode Island | 02818 | — |
| Coastal Carolina Research Center Site Number : 8400015 | North Charleston | South Carolina | 29405 | — |
| DM Clinical Research - CyFair Site Number : 8400025 | Houston | Texas | 77065 | — |
| Be Well Clinical Studies -Round Rock Site Number : 8400038 | Round Rock | Texas | 78681 | — |
| IMA Clinical Research-San Antonio Site Number : 8400039 | San Antonio | Texas | 78229 | — |
| Martin Diagnostic Clinic Site Number : 8400026 | Tomball | Texas | 77375 | — |
| Velocity Clinical Research Site Number : 8400018 | West Jordan | Utah | 84088-8865 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05639894, 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 Aug 5, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05639894 live on ClinicalTrials.gov.