Safety, tolerability and immunogenicity of intradermal mRNA SARS-CoV2 vaccination in patients with Fibrodysplasia Ossificans Progressiva

Phase 2

Conditions: Fibrodysplasia ossificans progressiva
FOP
Stone man syndrome
10028396

Registration Number: NL-OMON53330

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Fibrodysplasia ossificans progressiva as determined by confirmation of any
causative genetic mutation in the ACVR1 gene
• 18 years or older
• Participants who are willing and able to comply with all scheduled visits,
vaccination tests and other study procedure
• Capable of giving personal signed consent as described in appendix 1, which
includes compliance with the requirements and restrictions listed in the ICD
and this protocol

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Nature, frequency and severity of local reactions. Solicited adverse events<br /><br>include: pain, redness and swelling at the injection site and pain and swelling<br /><br>at the regional lymph nodes<br /><br><br /><br>Nature, frequency and severity of systemic events. Solicited adverse events<br /><br>include: flare-up, fever, fatigue, headache, chills, vomiting, diarrhoea, new<br /><br>or worsened muscle pain, and new or worsened joint pain.<br /><br><br /><br>Use of corticosteroids, antipyretics and painkillers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• SARS-CoV 2 WT neutralising antibody titres rate on Day 1 and Day 43<br /><br>• SARS-CoV-2-spike protein-specific binding IgG level on Day 1 and Day 43<br /><br>• B-cell and T-cell responses on day 1 and day 43</p><br>

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