Systems Biological Analysis of Immune Responses to RSV Vaccine

NCT07185399 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00010088
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

RSV vaccine; Lower respiratory track disease

Outcome Measures

Primary Outcomes (1)

• 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 180 post-vaccination.

  Days 28 and 180 post-vaccination

Secondary Outcomes (4)

• Frequency of Grade 2 or Higher Adverse Events

  Day 28 post-vaccination

• Severity of Grade 2 or Higher Adverse Events

  Day 28 post-vaccination

• Occurrence of Serious Adverse Events

  Up to Day 180 post-vaccination

• Occurrence of Adverse Events Meeting VAERS Reporting Criteria

  Up to Day 180 post-vaccination

Study Arms (1)

Moderna RSV vaccine (MRESVIA)

EXPERIMENTAL

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

Interventions

Moderna RSV vaccine BIOLOGICAL

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.

Moderna RSV vaccine (MRESVIA)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Open Philanthropy: collaborator

Study Sites (1)

The Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available within 12 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: Data will be available for sharing with qualified researchers from academic, nonprofit, or governmental institutions, for the purposes of analyses consistent with advancing scientific knowledge in vaccinology and immunology. Requests will be reviewed by the study PI. Approved investigators will sign a data use agreement (DUA) and data will be shared through secure transfer methods.

Locations

US (1)