A Phase 4 interventional study of Moderna RSV vaccine in Respiratory Syncytial Virus (RSV), sponsored by Emory University. Active, not recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Emory University · Phase 4, Interventional, and Basic science
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.
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.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Exclusion Criteria:
Immunocompromising conditions, including:
Adults who are ≥60 years of age and are eligible to receive FDA-approved RSV vaccines under standard clinical recommendations receive a single dose of the Moderna RSV vaccine (MRESVIA).
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.
Antibody Titers
The magnitude of RSV-specific antibody responses following vaccination with an mRNA RSV vaccine (MRESVIA) is assessed as antibody titers at Days 28 and 365 post-vaccination.
Time frame: Days 28 and 365 post-vaccination
Frequency of Grade 2 or Higher Adverse Events
The frequency of unsolicited adverse events (AEs) of Grade 2 or higher occurring within 28 days following vaccination will be examined.
Time frame: Day 28 post-vaccination
Severity of Grade 2 or Higher Adverse Events
The severity of unsolicited adverse events (AEs) of Grade 2 or higher occurring within 28 days following vaccination will be examined.
Time frame: Day 28 post-vaccination
Occurrence of Serious Adverse Events
The occurrence of any serious adverse event (SAE) at any point during the 1-year follow-up period will be examined.
Time frame: Up to Day 365 post-vaccination
Occurrence of Adverse Events Meeting VAERS Reporting Criteria
The occurrence of any adverse event that meets VAERS reporting criteria during the 1-year follow-up will be examined. VAERS reporting criteria include: Anaphylaxis (within 7 days); Syncope (within 7 days); Shoulder Injury Related to Vaccine Administration (SIRVA); Acute complications or sequelae of anaphylaxis, syncope, or SIRVA; Events listed as contraindications in the vaccine's package insert; Any SAE, especially if unexpected or deemed related to the vaccine.
Time frame: Up to Day 365 post-vaccination
Plan to share: Yes — De-identified individual participant data (IPD) will be shared upon reasonable request, following completion of primary analyses. Data that will be available for sharing include de-identified demographic, safety, and immunogenicity data, as well as omics datasets (e.g., transcriptomics, proteomics, metabolomics) collected pre- and post-vaccination. Data dictionaries will also be provided.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Emory University