Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 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 of the following: i. Autologous stem cell transplant received more than 90 days prior to first study vaccination, ii. Allogeneic stem cell transplant received more than 90 days prior to first study vaccination, iii. Chimeric antigen receptor T cell (CAR-T) therapy received more than 90 days prior to first study vaccination
You may not qualify if…
- ✕ Known history of hypersensitivity to any vaccine or history of a life-threatening reaction to a vaccine
- ✕ Previous vaccination with any licensed or investigational RSV vaccine
- ✕ Acute or chronic clinically significant/unstable neurological disease (such as uncontrolled seizures, strokes, Guillain-Barré Syndrome (GBS)
- ✕ Vaccination with any inactivated, subunit, or split influenza vaccine or COVID-19 vaccine within 14 days prior to first study vaccination, or vaccination with any other licensed or investigational vaccine within 30 days prior to first study vaccination
- ✕ Receipt of investigational or approved monoclonal antibodies against RSV within 90 days prior to first study vaccination
- ✕ Moderate or severe acute illness/infection (in opinion of the Investigator) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of first study vaccination. A prospective participant should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
- ✕ Any medical condition that in the opinion of the Investigator would make intramuscular injection unsafe
- ✕ Receipt of immunoglobulins or plasma products within 90 days prior to first study vaccination
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT07050732 · last updated 2025-12-12