Not recruiting

Study on the Effectiveness of Modified Vaccinia Ankara Vaccine in Preventing Mpox Infection in Adults

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 prevention of Mpox infection, which is a disease caused by a virus similar to the one that causes smallpox. The study will use a vaccine called IMVANEX, which is a suspension for injection containing a live virus known as Modified Vaccinia Ankara – Bavarian Nordic Live Virus. This vaccine is designed to help the body build protection against the Mpox virus.

The purpose of the study is to understand how the body's immune response, specifically the antibodies that fight the virus, changes over time after receiving the vaccine. Participants in the study will receive either one or two doses of the vaccine. The study will monitor the levels of these antibodies at different times, up to 48 weeks after vaccination. This will help researchers learn more about how long the vaccine's protection lasts and what factors might influence this.

Throughout the study, participants will have regular check-ups to measure the presence of antibodies and to ensure their well-being. The study will also look at the vaccine's ability to neutralize the virus in laboratory settings and check for any other infections that might occur during the study period. This research aims to provide valuable information on the effectiveness of the IMVANEX vaccine in preventing Mpox infection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
To join the study, you must be at least 18 years old and understand the study procedures. You need to voluntarily agree to participate by giving written, informed consent.
You must be eligible for 1 or 2 doses of the MVA vaccine for Mpox prevention according to guidelines, or have received the first dose less than 28 days ago.
Step 2
Vaccination
You will receive the IMVANEX vaccine, which is a suspension for injection. This vaccine is used to prevent smallpox and monkeypox infections.
The vaccine is administered through an injection. The number of doses you receive will depend on your eligibility.
Step 3
Monitoring and follow-up
Your antibody levels will be monitored at various intervals: at the start, and then at weeks 2, 6, 12, and 48 after vaccination.
Swabs may be taken from the throat, anorectal, or vaginal areas at the same intervals to check for the presence of Mpox DNA.
The study will also monitor the frequency of sexually transmitted infections (STIs) at the start and at weeks 6, 12, and 48.
Step 4
Study duration
The study is expected to end by May 1, 2025.
Recruitment for the study is estimated to start on February 15, 2024.

Who can join the trial?

3 criteria

Be at least 18 years old.
Understand the study procedures, be able to follow them, and agree to participate by signing a written, informed consent form. This means you understand what the study involves and agree to take part.
Be eligible for 1 or 2 doses of **MVA** for **Mpox** prevention according to **NIAC** guidelines, or have received the first dose of **MVA** less than 28 days ago for **Mpox** prevention. **MVA** is a type of vaccine, and **Mpox** is the condition being studied. **NIAC** refers to guidelines from a health authority.

Who cannot join the trial?

1 criterion

Individuals who currently have an **Mpox infection** cannot participate. **Mpox** is a viral infection that can cause symptoms like fever and rash.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Cork University Hospital
Verified
Cork, Ireland
St Vincent's University Hospital
Verified
Dublin, Ireland
University Hospital Galway
Verified
Galway, Ireland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

MVA Vaccine The MVA vaccine is being studied to see how well it can prevent Mpox infection. The trial aims to understand how long the antibodies produced by the vaccine last in the body and what factors might affect this. Participants in the study receive the MVA vaccine to help researchers gather this important information.

Modified Vaccinia Ankara – Bavarian Nordic Live Virus

What is already known about the treatment

MVA Vaccine – The MVA vaccine is administered through an injection, typically into the upper arm. It is currently being studied in clinical trials for its effectiveness in preventing Mpox infection. The main therapeutic indication for this vaccine is to stimulate the immune system to produce antibodies specific to the Mpox virus, thereby providing immunity against the infection. At the molecular level, the vaccine works by introducing a modified virus that cannot replicate, prompting the body to recognize and fight the actual virus if exposed. It is classified as a viral vaccine in pharmacology.

Investigated diseases

Mpox infection – Mpox, also known as monkeypox, is a viral disease that causes symptoms similar to smallpox, though generally milder. It begins with fever, headache, muscle aches, and fatigue, followed by a rash that often starts on the face and spreads to other parts of the body. The rash progresses from macules to papules, vesicles, pustules, and finally scabs. Lymph nodes may swell, which is a distinguishing feature from smallpox. The disease is primarily transmitted to humans from animals, but human-to-human transmission can occur through close contact. The infection typically resolves on its own, but the duration and severity can vary.