NCT07185399

Systems Biological Analysis of Immune Responses to RSV Vaccine

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.

Detailed description

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease (LRTD) in older adults and individuals with chronic comorbidities. In response to this burden, several RSV vaccines have recently been licensed for use in adults ≥60 years of age, including products developed by Pfizer, GlaxoSmithKline (GSK), and Moderna. These vaccines represent distinct technological platforms - recombinant protein with adjuvant, bivalent prefusion F (preF) subunit, and messenger RNA (mRNA), respectively - each with demonstrated efficacy in large-scale clinical trials. Understanding the immunological mechanisms and durability of protection across these platforms remains a major research priority, particularly given the increased use of next-generation vaccine technologies such as mRNA. Systems biology approaches, including transcriptomics, proteomics, metabolomics and advanced immune profiling, provide a powerful means to identify early biomarkers of immunogenicity and long-term antibody persistence. Such approaches have successfully revealed predictive immune signatures in response to a variety of vaccines. In parallel studies, the researchers have collected samples from individuals who received the Pfizer and GSK RSV vaccines at retail pharmacies under routine clinical use. However, the mRNA-based RSV vaccine (MRESVIA, developed by Moderna) has been less widely deployed to date in community settings, limiting opportunities to collect samples prospectively under real-world conditions. As a result, the researchers are establishing this dedicated protocol to characterize the immune response to MRESVIA using a systems biology approach. Through comprehensive sampling at early and late timepoints post-vaccination, the researchers aim to define molecular and cellular features unique to the mRNA platform and identify early predictors of immune response magnitude and durability. These data will also support future cross-platform comparisons.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Moderna RSV vaccine	Participants will receive the MRESVIA vaccine (Moderna RSV vaccine) as part of the study. The vaccine will be administered by trained clinical personnel at the Hope Clinic. MRESVIA is FDA-approved and will be used in accordance with its licensed indication for adults aged 60 years and older. MRESVIA is an mRNA-based RSV vaccine containing 50 micrograms (mcg) of nucleoside-modified mRNA encoding the RSV prefusion F glycoprotein. It is supplied as a frozen injectable suspension in single-dose, pre-filled syringes. The vaccine is administered as a single 0.5 milliliter (mL) intramuscular injection.

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-09-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study