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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials