Fibrodysplasia ossificans progressiva FOP Stone man syndrome
Conditions
Interventions
Participants will receive 20 µg mRNA-1273 vaccine followed by a second dose on
day 28 through the intradermal route
Fibrodyplasia ossificans progressiva
heterotopic ossification
SARS-CoV-2
Vaccination
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Fibrodysplasia ossificans progressiva as determined by confirmation of any causative genetic mutation in the ACVR1 gene as previously described (1). • 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 • Females only: female volunteers of childbearing potential (i.e. have a uterus and are neither surgically sterilised nor post-menopausal) must not be pregnant or breastfeeding. They should agree to use adequate contraception at least up to four weeks following the final dose of mRNA-1273 vaccine.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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. • Women who are pregnant or breastfeeding. • Planned pregnancy within four weeks after the final injection. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Nature, frequency and severity of local reactions. Solicited adverse events include: pain, redness and swelling at the injection site and pain and swelling at the regional lymph nodes • Nature, frequency and severity of systemic events. Solicited adverse events include: flare-up, fever, fatigue, headache, chills, vomiting, diarrhoea, new or worsened muscle pain, and new or worsened joint pain. • Use of corticosteroids, antipyretics and painkillers | — |
Secondary
| Measure | Time frame |
|---|---|
| • SARS-CoV 2 WT neutralising antibody titres rate on Day 1 and Day 43 • SARS-CoV-2-spike protein-specific binding IgG level on Day 1 and Day 43 • B-cell and T-cell responses on day 1 and day 43 | — |
Countries
The Netherlands
Outcome results
None listed