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RECRUITING
NCT07050732
PHASE2

Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-12-04

Completion Date

2028-04

Last Updated

2025-12-12

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States