Study on the Safety of Intradermal mRNA COVID-19 Vaccine Bretovameran for Patients with Fibrodysplasia Ossificans Progressiva

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new vaccination method for patients with Fibrodysplasia Ossificans Progressiva (FOP). FOP is a rare condition where the body’s soft tissues gradually turn into bone, leading to mobility issues. The study involves a fractional dose of the Comirnaty JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine, which contains the active substance bretovameran. This vaccine is designed to protect against the SARS-CoV-2 virus, which causes COVID-19. The vaccine will be administered as an intradermal injection, meaning it is injected just under the skin, rather than into the muscle.

The purpose of the study is to assess the safety of this vaccination method in FOP patients. Participants will receive a smaller dose than usual, specifically one-fifth of the regular dose. The study will monitor participants for any side effects, such as flare-ups, fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain, and joint pain. Additionally, the study will evaluate the body’s immune response to the vaccine by measuring antibody levels on specific days throughout the study period.

Participants will be observed for any local reactions at the injection site, such as pain, redness, and swelling, as well as any reactions in nearby lymph nodes. The use of medications like corticosteroids, antipyretics, and painkillers will also be tracked. The study aims to provide valuable information on how well the vaccine works and how safe it is for people with FOP, contributing to better healthcare options for those affected by this rare condition.

1 initial vaccination

Receive the first dose of the Comirnaty JN.1 vaccine, which is an mRNA vaccine for COVID-19.

The vaccine is administered as an intradermal injection, meaning it is injected into the skin.

The dosage is 30 micrograms per dose.

2 monitoring period

After the initial vaccination, monitor for any systemic events such as flare-ups, fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

Local reactions such as pain, redness, and swelling at the injection site, as well as pain and swelling at the regional lymph nodes, are also monitored.

Use of medications like corticosteroids, antipyretics, and painkillers may be recorded if needed.

3 antibody testing

On day 1, day 29, and day 43, blood samples are taken to measure the levels of SARS-CoV-2 neutralising antibodies and SARS-CoV-2-spike protein-specific IgG antibodies.

These tests help assess the immune response to the vaccine.

4 follow-up vaccination

Receive a follow-up dose of the vaccine as part of the study protocol.

The timing and dosage are consistent with the initial vaccination.

5 final assessment

Complete a final assessment to evaluate the overall safety and efficacy of the vaccination.

This includes reviewing any adverse events and the immune response data collected throughout the trial.

Who Can Join the Study?

Must be 18 years or older.
Must have a clinical diagnosis of Fibrodysplasia Ossificans Progressiva (FOP). This means a doctor has confirmed the condition by finding a specific change, called a genetic mutation, in the ACVR1 gene.
Must be willing and able to attend all scheduled visits, take vaccination tests, and follow other study procedures.
Must be able to give personal signed consent. This means you agree to follow the study’s rules and understand what is involved.

Who Cannot Join the Study?

Patients who do not have Fibrodysplasia Ossificans Progressiva (FOP) cannot participate. FOP is a rare condition where muscles and tissues turn into bone over time.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not automatically excluded, as the study does not specifically select vulnerable groups.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Aoxebftfz Usz	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	24.07.2023

Trial locations

mRNA SARS-CoV-2 Vaccine is being studied in this trial. It is a type of vaccine designed to protect against COVID-19. The vaccine uses a small piece of the virus’s genetic material, called mRNA, to teach the body’s immune system how to recognize and fight the virus if the person is exposed to it in the future. In this trial, the vaccine is given in smaller doses and injected into the skin to see if it is safe and effective for patients with a rare condition called Fibrodysplasia Ossificans Progressiva.

Investigated diseases:

Fibrodysplasia ossificans progressiva

Fibrodysplasia Ossificans Progressiva – This is a rare genetic disorder where soft tissues such as muscles, tendons, and ligaments gradually turn into bone. This abnormal bone formation can lead to restricted movement as joints become affected. The condition often begins in early childhood, with flare-ups that can be triggered by trauma or viral illnesses. Over time, the progressive ossification can severely limit mobility and lead to physical deformities. The disease is characterized by episodes of painful swelling and stiffness in the affected areas. It is caused by mutations in the ACVR1 gene, which plays a role in bone growth and development.

Trial ID:

2024-518686-10-00

Protocol code:

IVY1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Intradermal mRNA COVID-19 Vaccine Bretovameran for Patients with Fibrodysplasia Ossificans Progressiva

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?