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Safety and efficacy of intradermal mRNA SARS-CoV-2 vaccination in patients with Fibrodysplasia Ossificans Progressiva (IVY trial)
EU CTIS ID: 2024-518686-10-00
What this study is testing
To assess the safety of fractional, intradermal mRNA SARS-CoV-2 vaccination in patients with Fibrodysplasia Ossificans Progressiva
- Therapeutic use (Phase IV)
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
- Aged 18 years or older
- A clinical diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) as determined by confirmation of any causative genetic mutation in the ACVR1 gene
- Willing and able to comply with all scheduled visits, vaccination tests and other study procedure
- Capable of giving personal signed consent, which includes compliance with the requirements and restrictions
You likely can't join if
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
- Receipt of medications intended to prevent SARS-CoV-2 infection
- Current clinical complaints consistent with SARS-CoV-2 infection (three or more of the following complaints: headache, loss of smell, sore throat, hoarseness, cough, chest pain, shortness of breath, fatigue, diarrhea, fever)
- SARS-CoV-2 vaccination 6 months prior to participation
- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
See the full eligibility criteria
- Aged 18 years or older
- A clinical diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) as determined by confirmation of any causative genetic mutation in the ACVR1 gene
- Willing and able to comply with all scheduled visits, vaccination tests and other study procedure
- Capable of giving personal signed consent, which includes compliance with the requirements and restrictions
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
- Receipt of medications intended to prevent SARS-CoV-2 infection
- Current clinical complaints consistent with SARS-CoV-2 infection (three or more of the following complaints: headache, loss of smell, sore throat, hoarseness, cough, chest pain, shortness of breath, fatigue, diarrhea, fever)
- SARS-CoV-2 vaccination 6 months prior to participation
- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
- SARS-CoV-2 PCR-positive EMA approved lateral flow test at the screening before receipt of fist vaccine dose
- Receipt of any other non-study vaccine within 28 days, before first study dose
- Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.