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Systems Biological Analysis of Immune Responses to RSV Vaccine

NCT07185399 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-22

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • Open Philanthropy

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185399 on ClinicalTrials.gov