Status:
RECRUITING
Systems Biological Analysis of Immune Responses to RSV Vaccine
Lead Sponsor:
Emory University
Collaborating Sponsors:
Open Philanthropy
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 hig...
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 vacci...
Eligibility Criteria
Inclusion
- Adults ≥60 years of age at the time of enrollment.
- Able and willing to provide written informed consent.
- Eligible for receipt of an FDA-approved RSV vaccine (MRESVIA) per Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) guidelines.
- Available for all study visits and procedures, including follow-up through Day 180.
- Willing to allow access to prior RSV vaccination history (if applicable) for eligibility verification
Exclusion
- History of severe allergic reaction (e.g., anaphylaxis) to any prior vaccines or any component of the MRESVIA vaccine, including polyethylene glycol (PEG), the amino lipid SM-102 (SM-102), or other listed excipients.
- Acute illness or fever (temperature ≥100.4°F) at the time of vaccination (participant may be rescheduled).
- Immunocompromising conditions, including:
- Current cancer chemotherapy or immunosuppressive therapy.
- History of hematologic malignancies or other immune-mediated diseases that would interfere with vaccine response.
- Known or suspected HIV infection with cluster of differentiation 4 (CD4) count \<200 or uncontrolled viremia.
- Clinically significant cardiac, pulmonary, renal, hepatic, or neurological disease that, in the opinion of the investigator, would preclude participation or confound interpretation of immune data.
- Uncontrolled autoimmune disorder.
- Current use of systemic corticosteroids equivalent to ≥20 mg prednisone daily for more than 14 consecutive days in the past month.
- History of Guillain-Barré Syndrome or other demyelinating neurological disorders.
- History of myocarditis, pericarditis, or myopericarditis within the last 2 months.
- Any bleeding disorder that poses a risk for venipuncture or vaccination complications.
- Participation in another clinical trial involving an investigational agent within 30 days of enrollment.
- Receipt or plan receipt of vaccines in the past an upcoming 28 days.
- Prior receipt of any RSV vaccine.
- Receipt of blood products or immune globulin within the prior 3 months.
- History of excessive alcohol consumption or drug use, or psychiatric/social/occupational conditions that may interfere with study compliance.
- Any other condition that, in the opinion of the investigator, may interfere with study conduct or participant safety.
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07185399
Start Date
October 13 2025
End Date
June 1 2027
Last Update
October 17 2025
Active Locations (1)
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1
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030