BridgeMD
A phase-2b controlled study to evaluate the humoral and cellular immune response and safety following one and two doses of an adjuvanted RSV subunit vaccine in immunocompromised patients aged 18 years and older.
EU CTIS ID: 2024-513187-25-00
What this study is testing
To assess the Arexvy-induced humoral response after second vaccine dose over first vaccine dose with Arexvy in immunocompromised patients ≥ 18 YoA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.
- Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
- Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception as described in chapter 6.5.1. from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, and post-menopause.
- Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
- Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.
You likely can't join if
- Previous RSV vaccination, including investigational RSV vaccines.
- Pregnant or lactating female participant.
- Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
- History of ongoing chronic alcohol consumption and/or drug abuse.
- Participation of any study personnel or their immediate dependents.
- Any history of dementia or any medical condition that moderately or severely impairs cognition
See the full eligibility criteria
Who can join
- Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.
- Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.
- Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception as described in chapter 6.5.1. from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, and post-menopause.
- Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
- Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.
What rules you out
- Previous RSV vaccination, including investigational RSV vaccines.
- Pregnant or lactating female participant.
- Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
- History of ongoing chronic alcohol consumption and/or drug abuse.
- Participation of any study personnel or their immediate dependents.
- Any history of dementia or any medical condition that moderately or severely impairs cognition
- Expected unavailability for the planned study visits.
- Administration of immunoglobulins and/or any blood products or plasma derivatives within three months before first dose of Arexvy) and during the entire study participation.
- A confirmed or suspected primary immunodeficiency disease or HIV infection.
- Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to the use of induction and/or maintenance immunosuppressive therapies.
- Known hypersensitivity to a component of the study vaccine (Arexvy).
- Acute infection and/or fever at the time of study vaccine administration (>=38°C oral, tympanic or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.
- Acute or chronic clinically significant/unstable disease of the cardiovascular, renal, hepatic or neurological organ system (such as hemodialysis, liver cirrhosis (Child-Pugh class C), uncontrolled seizures etc.).
- Significant underlying illness that would prevent completion of the study.
- Contraindication for i. m. injection.
- Use of any other investigational or non-registered product (drug, vaccine, or medical device) less than 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period / participation (up to 12 months after last vaccination).
- Concurrently participating in another active clinical study that includes the application of investigational products (medication, vaccine, medical devices).
- Participant received other vaccinations starting from 30 days prior to the first dose and ending 30 days after the last dose. For COVID-19 and influenza vaccines a 14 day interval applies.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.