Actively Recruiting
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Led by Johns Hopkins University · Updated on 2025-12-12
170
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Willing and able to comply with study visits and procedures
- Medically stable at time of first vaccination
- Life expectancy of at least 365 days at first vaccination
- Included in at least one of the following groups:
- Cellular therapy recipients aged 18 or older with history of autologous or allogeneic stem cell transplant or CAR-T therapy received more than 90 days prior
- Solid organ transplant recipients aged 18 or older with a single-organ transplant at least 90 days prior and on at least 2 systemic immunosuppressive agents
- Healthy comparators aged 60 or older, or aged 50-59 with increased risk of severe RSV disease, without immune compromise
- Participants of childbearing potential must practice adequate contraception or abstinence from 1 month before first vaccination through 1 month after last vaccination and have a negative pregnancy test on first vaccination day
You will not qualify if you...
- Known allergy or life-threatening reaction to any vaccine
- Previous vaccination with any licensed or investigational RSV vaccine
- Acute or chronic unstable neurological disease such as uncontrolled seizures, strokes, or Guillain-Barré Syndrome
- Influenza or COVID-19 vaccine within 14 days prior to first vaccination, or any other vaccine within 30 days prior
- Receipt of monoclonal antibodies against RSV within 90 days prior
- Moderate or severe acute illness or fever (temperature ≥ 38.0°C) on vaccination day
- Medical conditions making intramuscular injection unsafe
- Receipt of immunoglobulins or plasma products within 90 days prior
- Receipt of B-cell depleting medications within 90 days prior
- Currently pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
- For cellular therapy recipients: graft-versus-host disease requiring systemic steroids at vaccination
- For solid organ transplant recipients: recent allograft rejection, lymphoproliferative disease, or treatment for these within 90 days
- For healthy comparators: any confirmed or suspected immunosuppressive or immunodeficient condition
- Other conditions that may increase risk or interfere with study participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
J
John Baddley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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