RecruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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 trial?

4 criteria

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.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

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Investigated drugs

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.

What is already known about the treatment

mRNA SARS-CoV-2 Vaccine – This vaccine is administered intradermally, meaning it is injected into the skin. It is currently being studied in clinical trials to evaluate its safety, tolerability, and immune response in patients with Fibrodysplasia Ossificans Progressiva (FOP). The main therapeutic indication is to provide protection against COVID-19 in this specific patient group. At the molecular level, the vaccine works by using messenger RNA (mRNA) to instruct cells to produce a protein similar to the spike protein of the virus, which then triggers an immune response. It is classified as an mRNA vaccine, a type of genetic vaccine that does not use live virus particles.

Investigated diseases

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.