Actively Recruiting
Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy4) Vaccine in Immunocompromised Adults
Led by Johns Hopkins University · Updated on 2025-12-12
170
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how well the vaccine Arexvy4, designed to protect against respiratory syncytial virus (RSV), works in people with weakened immune systems. The trial aims to find out whether one or two doses of Arexvy provide better protection and to monitor any medical problems participants experience after vaccination. The study is a randomized, single-blind Phase 2 trial including immunocompromised adults and a small group of healthy comparators. Participants with weakened immune systems are randomly assigned to one of two groups: one group receives a dose of Arexvy followed by a placebo vaccine 60 days later; the other group receives two doses of Arexvy 60 days apart. Both groups get a booster dose of Arexvy one year after the first dose. A third group of healthy adults receives a single dose of Arexvy. The study vaccines are given over the course of one year. During the study, participants will keep a symptom diary for a week after each vaccine dose. They will also attend three in-person follow-up visits for checkups and tests over 1.5 years, plus six phone follow-ups during the same period. Researchers will measure immune responses to the vaccine, including antibody levels and T-cell activity, and monitor any side effects or adverse events. The main outcome is the immune response 30 days after each vaccine dose.
CONDITIONS
Brief 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 follow study visits and procedures
- Medically stable at the time of first vaccination
- Life expectancy of at least 365 days at first vaccination
- Included in 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 at least 90 days prior
- Solid organ transplant recipients aged 18 or older who had ABO-compatible single-organ transplant at least 90 days prior and on at least two immunosuppressive drugs
- Healthy comparators aged 60 or older, or 50-59 at increased risk for severe RSV, without immune compromise
- Participants of childbearing potential must use adequate contraception or abstinence starting 1 month before first vaccination through 1 month after last vaccination and have a negative pregnancy test on vaccination day
You will not qualify if you...
- History of severe allergic reaction to any vaccine
- Previous RSV vaccination with licensed or investigational vaccine
- Acute or unstable neurological disease such as uncontrolled seizures or Guillain-Barr�e9 Syndrome
- Recent influenza, COVID-19, or other vaccine within specified days before first vaccination
- Receipt of RSV monoclonal antibodies within 90 days before first vaccination
- Moderate or severe illness or fever on vaccination day
- Medical condition making intramuscular injection unsafe
- Receipt of immunoglobulins or plasma products within 90 days before first vaccination
- Use of B-cell depleting medications within 90 days before first vaccination
- Currently pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
- For cellular therapy recipients: active graft-versus-host disease requiring systemic treatment
- For solid organ transplant recipients: recent allograft rejection or related treatment within 90 days
- For healthy comparators: any known immunosuppressive or immunodeficient condition
- Any other condition that may pose risk, interfere with study compliance, or affect data quality as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 year
Participants receive one or two doses of the Arexvy vaccine or placebo at enrollment and Day 60, followed by a re-vaccination dose at 1 year depending on their assigned group.
3 vaccination visits at enrollment, Day 60, and Day 365
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
J
John Baddley, MD
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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