Johns Hopkins University
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
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.
Inclusion Criteria: * Able to understand and provide informed consent * Willing and able to comply with the requirements and restrictions in the protocol, including study visits and study-related procedures * Medically stable in the opinion of the Investigator at the time of first study vaccination * Life expectancy ≥ 365 days in the opinion of the Investigator at the time of first study vaccination * Included in at least one of the groups below: 1. Cellular therapy recipients (CTR): * Individuals ≥ 18 years of age at the time of first study vaccination * History of at least one…
Arexvy at enrollment, Arexvy at Day 365
Arexvy at enrollment, Day 60, and Day 365
Arexvy at enrollment
Placebo vaccine at day 60
Arctuva estimate
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