Fibrodyplasia Ossificans Progressiva (FOP) MedDRA version: 20.0 Level: PT Classification code 10068715 Term: Fibrodysplasia ossificans progressiva System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: COVID-19 Vaccine Moderna
Product Name: COVID-19 Vaccine Moderna
Product Code: EMEA/H/C/005791
Pharmaceutical Form: Concentrate and solvent for suspension for injection
Sponsors
Amsterdam University Medical Center
Eligibility
Sex/Gender
All
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: To describe and investigate safety and tolerability of the intradermal delivery of two fractional doses of 20 µg mRNA-1273 in patients with Fibrodysplasia Ossificans Progressiva.;Secondary Objective: To compare the immunogenicity of patients with FOP after intradermal delivery of two fractional doses of 20 µg mRNA-1273 with that of two doses of 20 µg mRNA-1273 vaccine through intramuscular delivery and intradermal delivery on Day 43, as previously investigated in LUMC cohort of healthy adults;Primary end point(s): •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 ;Timepoint(s) of evaluation of this end point: Throughout study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 ;Timepoint(s) of evaluation of this end point: Day 1 and Day 43 | — |
Countries
Netherlands
Contacts
Public ContactEMW Eekhoff
Amsterdam University Medical Center
Outcome results
None listed