Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons

Launched by JOHNS HOPKINS UNIVERSITY · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a vaccine called Arexvy® that aims to protect against respiratory syncytial virus (RSV), a common virus that can cause lung and breathing problems. The study focuses on people with weakened immune systems, such as those who have had certain kinds of transplants or specific immune-related treatments. Researchers want to find out whether giving one or two doses of the vaccine works better for these individuals and what side effects or health issues might happen after vaccination.

If you join the study, you will receive three vaccine doses over one year and be asked to keep a diary of any symptoms for a week after each shot. You will also have several checkups and tests during in-person visits and phone calls over the next year and a half. To be eligible, participants need to be medically stable adults who have had specific transplant procedures or treatments at least three months before starting the study, or be healthy older adults at higher risk of severe RSV. You must also be willing to follow the study’s rules, including using birth control if applicable. This trial is not yet open for enrollment but aims to help understand how well the vaccine works and how safe it is for people with weaker immune systems.

Gender

ALL

Eligibility criteria

• 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 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
• 2. Solid organ transplant recipients (SOTR):
• • Individuals ≥ 18 years of age at the time of first study vaccination
• • Received an ABO-compatible, single-organ type, solid organ transplant (lung, heart, kidney, liver) at least 90 days prior to first study vaccination, and are on at least 2 systemic immunosuppressive agents at time of first study vaccination
• 3. Healthy comparator (HC):
• • Individuals ≥ 60 years of age at the time of first study vaccination or 50-59 years of age at the time of first study vaccination and at increased risk of severe RSV disease
• • No history of (a) or (b) above, and considered healthy or with chronic and stable medical conditions in the opinion of the Investigator, without immune compromise
• • Participants of childbearing potential if practicing adequate contraception or abstinence from 1 month prior to first study vaccination and agree to continue adequate contraception or abstinence through at least 1 month after last study vaccination. All participants of childbearing potential must have a negative pregnancy test on the day of first study vaccination, prior to administration.
• Exclusion Criteria:
• • 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
• • Receipt of B-cell depleting medications (e.g., Rituximab, ocrelizumab, ofatumumab, belimumab, epratuzumab, antithymocyte globulin) within 90 days prior to first study vaccination
• • Currently pregnant or breastfeeding or planning to become pregnant, discontinue contraception, or breastfeed during the study period
• * Any of the following:
• 1. Cellular therapy recipients (CTR):
• • Graft-versus-host disease (GVHD) requiring systemic treatment with at least 0.5 mg/kg per day of prednisone or equivalent at time of first study vaccine
• 2. Solid organ transplant recipients (SOTR):
• • History of any of the following within 90 days prior to first study vaccination: allograft rejection, post-transplant lymphoproliferative disease, treatment for either of these conditions
• 3. Healthy comparator (HC):
• • Any confirmed/suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive or cytotoxic therapy, based on medical history
• • Any other conditions which, in the opinion of the Investigator, may pose additional risks from participation in the study, may interfere with the individual's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study