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New treatment option for Respiratory Syncytial Virus (RSV)
Official title Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
ClinicalTrials.gov ID: NCT07050732
What this study is testing
What is Arexvy (2 doses total)?
Arexvy (2 doses total) is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus (rsv).
Also referred to as adjuvanted RSVPreF3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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:
You likely can't join 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...
- 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...
See the full eligibility 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:
- 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...
- 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...
- 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...
- 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...
- 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...
- 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:
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.