Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Recruiting
Study on the Safety and Immune Response of the MVA-BN Vaccine Booster for Monkeypox Prevention in Previously Vaccinated Patients
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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 the prevention of monkeypox, also known as mpox, which is a viral infection. The study is investigating the use of a vaccine called Modified Vaccinia Ankara – Bavarian Nordic Live Virus, also referred to as MVA-BN. This vaccine is given as a booster dose to help protect against mpox. The trial will compare two methods of administering the booster dose: one given just under the skin, known as subcutaneous injection, and the other given into the skin, known as intradermal use.
The purpose of the study is to see if the intradermal booster dose is as effective as the subcutaneous booster dose in creating an immune response, which is the body's way of defending against infections. Participants in the study will receive either the intradermal or subcutaneous booster dose, and their immune response will be monitored over time. The study will also look at the safety of the vaccine and any side effects that may occur.
Participants will be followed for a period of time to assess their immune response at different intervals, such as one month and six months after receiving the booster dose. The study will also monitor for any serious side effects and the occurrence of any breakthrough infections, which are infections that occur despite vaccination. The trial aims to provide valuable information on the best way to use the MVA-BN vaccine to protect against mpox.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Adults aged 18 years or older.
- Received a dose of the MVA-BN vaccine at least 4 months ago.
- Individuals who are willing and able to participate and have signed a written consent to participate in the study.
- Individuals who expect to be available for monitoring during the entire study period.
- Men who have sex with men (specific trial sites).
- Individuals who received a specific dose of the MVA-BN vaccine in a 2-dose regime approximately four weeks apart, or previously vaccinated individuals who have received only one dose as a primary regimen (specific trial sites).
- Eligible for a booster dose, as recommended by health authorities (specific trial sites).
- Women must test negative in a pregnancy test (specific trial sites).
Who cannot join the trial?
10 criteria
- People who are not in the age range specified for the study cannot participate.
- Individuals who are part of a vulnerable population are not eligible to join the study.
- Participants must not have any medical conditions that could interfere with the study.
- Anyone who has had a severe allergic reaction to any component of the study vaccine cannot participate.
- Individuals who are currently participating in another clinical trial are not eligible.
- Pregnant or breastfeeding women are not allowed to participate in the study.
- People with a weakened immune system, which means their body has a harder time fighting infections, cannot join the study.
- Anyone who has received a live vaccine within the last 30 days is not eligible.
- Individuals with a history of certain skin conditions, like eczema, may not be able to participate.
- Participants must not have any serious chronic illnesses that are not well controlled.
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Verified Verified Centre Hospitalier Universitaire De Nantes
Nantes, FranceResponsive Soedersjukhuset AB
Stockholm, Sweden
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Investigated drugs
MVA-BN Vaccine is a type of vaccine designed to help protect against a virus called Mpox. In this clinical trial, the vaccine is being tested to see how well it works when given as a booster shot. A booster shot is an additional dose of a vaccine given after the initial series of shots to help maintain or increase the body's immune response. The trial is looking at two different ways of giving the booster shot: either just under the skin (intradermal) or deeper under the skin (subcutaneous). The goal is to see which method helps the body produce a better immune response, which is the body's way of fighting off infections. This vaccine is being tested in people who have already received the initial vaccination series, as well as in those who have not. The study aims to ensure that the booster shot is safe and effective in providing protection against the Mpox virus.
What is already known about the treatment
MVA-BN Vaccine – This vaccine is administered either intradermally (into the skin) or subcutaneously (under the skin) as a booster dose to enhance the body's immune response against monkeypox (mpox) infection. Currently, it is being studied in clinical trials to assess its effectiveness and safety in providing protection against mpox. The main therapeutic use of this vaccine is to prevent mpox infection. At the molecular level, the vaccine works by stimulating the immune system to recognize and fight the virus if exposed in the future. It is classified as a vaccine in pharmacology.
Investigated diseases
Monkeypox – Monkeypox is a viral infection caused by the monkeypox virus, which is related to the smallpox virus. It begins with symptoms such as fever, headache, muscle aches, and fatigue. As the disease progresses, a rash develops, often starting on the face and then spreading to other parts of the body. The rash evolves from flat lesions to raised bumps, then to fluid-filled blisters, and finally to scabs. The disease is typically self-limiting, with symptoms lasting for several weeks. Transmission occurs through direct contact with the lesions, bodily fluids, or respiratory droplets of an infected person or animal.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518007-22-00Estimated enrolment665 patientsSponsorThe Public Health Agency Of Sweden
sourced from the EU Clinical Trials Register and site verification
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