NCT07050732

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are: * Does 1 or 2 doses of Arexvy work better in people with weakened immune systems? * What medical problems do participants have after receiving Arexvy? Participants with weakened immune systems will: * Receive 3 study vaccines over the course of 1 year * Keep a diary of symptoms for 7 days after each vaccine * Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years * Have 6 phone follow up study visits over the course of 1.5 years

Detailed description

People with weakened immune systems will be randomized to either: 1. Receive one dose of Arexvy followed by a placebo vaccine (sterile saline) 60 days later, or 2. Receive one dose of Arexvy followed by another dose of Arexvy 60 days later Both groups will also receive another dose of Arexvy 1 year after the first dose. A small group of people without weakened immune systems will also be enrolled in the study. This group will receive one dose of Arexvy.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Arexvy (2 doses total)	Arexvy at enrollment, Arexvy at Day 365
BIOLOGICAL	Arexvy (3 doses total)	Arexvy at enrollment, Day 60, and Day 365
BIOLOGICAL	Arexvy (1 dose total)	Arexvy at enrollment
OTHER	Placebo	Placebo vaccine at day 60

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-11-01
• Completion: 2028-04-01
• First posted: 2025-07-03
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study