COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000692-39/NL

Amsterdam University Medical Center - EMW Eekhoff

fop.amsterdam@vumc.nl

2023-03-31

Recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

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.

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.

1

Amsterdam University Medical Center

18

65

Netherlands

Healthy volunteers

N/A

10

• 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

Not reported

Phase 2

[{"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]