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Systems Biological Analysis of Immune Responses to RSV Vaccine

Study acronym: RSV SB
StatusActive, Not Recruiting
PhasePhase 4
Started2025-10-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Jan 2027
See other at-risk trials from Emory University

Amendment history

2026-08-10
Study Status, Outcome Measures, Eligibility v3
Primary completion pushed: 2026-07 → 2027-01
Completion pushed: 2026-07 → 2027-01
Eligibility criteriarevised
[...] tudy visits and procedures, including follow-up through Day 180365. Willing to allow access to prior RSV vaccination history ( [...]
Secondary endpointsdetails revised at 2 of 4 entries
2026-01-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-06→2026-07
Completion date2027-06→2026-07
Enrollment targetestimated 20→confirmed 14
Study sitesdetails revised at 1 of 1 site
2025-10-15
Not Yet Recruiting→Recruiting Study Status, Study Description, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-22→confirmed 2025-10-13
Eligibility criteria+56 characters
[...] f the MRESVIA vaccine, including polyethylene glycol (PEG), the amino lipid SM-102 (SM-102), or other listed excipients. Acute illness or fever (temper [...] ith vaccine response. Known or suspected HIV infection with cluster of differentiation 4 (CD4) count <200 or uncontrolled viremia. Clinically significant [...]
Study description+14 characters
[...] cal platforms - recombinant protein with adjuvant, bivalent prefusion F (preF) subunit, and messenger RNA (mRNA), respectively - each with [...]
Study sitesdetails revised at 1 of 1 site
2025-09-15
Original filing
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.
Trial Details
NCT Number NCT07185399
Lead Sponsor Emory University
Collaborators: Open Philanthropy
Conditions Respiratory Syncytial Virus (RSV)
Enrollment 14 participants
Start Date 2025-10-13
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-12