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Study on the Effectiveness of Skin Patch Vaccination with Measles, Mumps, and Rubella Vaccine in Healthy Volunteers

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 effects of the Measles, Mumps, and Rubella (MMR) vaccine. The diseases being studied are measles, mumps, and rubella, which are viral infections that can cause serious health problems. The treatment being tested is the M-M-RvaxPro vaccine, which is a live vaccine designed to protect against these three diseases. The vaccine is given as a suspension for injection, which means it is a liquid that is injected into the body.

The purpose of the study is to compare two different methods of administering the MMR vaccine to see if one method is more effective than the other. One method involves the traditional injection under the skin, while the other method involves a new approach called epicutaneous vaccination, where the vaccine is applied to the skin. The study will observe the immune response, specifically looking at the production of a type of antibody called IgA, which plays a crucial role in the body's defense against infections. The study will also monitor other immune responses and any side effects that may occur after vaccination.

Participants in the study will receive both types of vaccine administration at different times, and their immune responses will be measured over a period of three months. The study aims to determine if the new method of applying the vaccine to the skin can generate a similar immune response to the traditional injection method. This research could potentially lead to new ways of administering vaccines in the future, making them more accessible and easier to use.

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
Initial vaccination
Upon joining the study, you will receive the M-M-RvaxPro vaccine. This vaccine is used to protect against measles, mumps, and rubella.
The vaccine will be administered as a suspension for injection. It can be given either as an injection under the skin or directly into the skin.
Step 2
Monitoring period
After receiving the vaccine, you will be monitored for any side effects or adverse events for a period of 30 days.
During this time, you may be asked to report any symptoms or changes in your health.
Step 3
Follow-up assessment
Three months after the vaccination, your immune response will be assessed.
This will involve measuring the levels of specific antibodies in your body, which help to protect against measles, mumps, and rubella.
The assessment will include tests on nasal secretions, blood samples, and possibly tonsil brushings to evaluate the immune response.
Step 4
Comparison of vaccination methods
The study aims to compare the immune response generated by the epicutaneous vaccination method (injection into the skin) with the standard method (injection under the skin).
The primary focus is on the levels of specific antibodies three months after vaccination.

Who can join the trial?

4 criteria

Age between 18 and 34 years old.
Must not have received the MMR vaccine before. MMR stands for Measles, Mumps, and Rubella.
Must be in good health.
Female participants must use safe methods to prevent pregnancy during the study.

Who cannot join the trial?

9 criteria

Individuals who have had a severe allergic reaction to any component of the MMR vaccine (Measles, Mumps, and Rubella vaccine) cannot participate.
People with a weakened immune system, which means their body has a harder time fighting infections, are not eligible.
Pregnant women are not allowed to join the study.
Anyone who has received another vaccine within the last 4 weeks cannot take part.
Participants who have a fever or any other signs of illness at the time of the study will be excluded.
Individuals who are currently taking medications that affect the immune system, such as steroids, are not eligible.
People with a history of blood disorders or bleeding problems cannot participate.
Anyone who has received a blood transfusion or blood products in the last 3 months is not eligible.
Participants who have participated in another clinical trial within the last 30 days cannot join.

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Verified sites

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Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

Measles, Mumps, and Rubella (MMR) vaccine is a combination vaccine that helps protect against three different diseases: measles, mumps, and rubella. In this clinical trial, the MMR vaccine is used in a special way called epicutaneous vaccination, which means it is applied to the skin. The goal is to see if this method can create a strong immune response in the respiratory system, specifically by producing a type of antibody called IgA, which helps protect against infections in areas like the nose and throat. This study aims to find out if this method of vaccination can effectively trigger the body's defenses against these diseases.

What is already known about the treatment

MMR Vaccine – The MMR vaccine is administered through the skin, a method known as epicutaneous vaccination, which is being studied to see if it can effectively trigger immune responses in the respiratory system. Currently, this vaccine is well-established in medical literature for preventing measles, mumps, and rubella, but this trial is exploring a new way to deliver it. The main therapeutic use of the MMR vaccine is to protect against these three viral infections. At the molecular level, the vaccine works by introducing weakened forms of the viruses to the body, prompting the immune system to produce antibodies that can fight off future infections. It is classified as a live attenuated vaccine, meaning it contains live viruses that have been weakened so they do not cause disease in healthy people.

Investigated diseases

Measles
Measles is a highly contagious viral infection caused by the measles virus. It begins with symptoms such as fever, cough, runny nose, and red eyes. After a few days, a red rash appears, starting on the face and spreading to the rest of the body. The disease progresses with the rash lasting for about a week. Measles can lead to complications like ear infections or diarrhea. The virus spreads through respiratory droplets from coughs or sneezes.
Mumps
Mumps is a viral infection primarily affecting the salivary glands, caused by the mumps virus. It typically starts with symptoms like fever, headache, muscle aches, and fatigue. The hallmark of mumps is the swelling of the parotid glands, located near the ears, leading to puffy cheeks and a tender, swollen jaw. The swelling usually lasts for about a week. Mumps spreads through infected respiratory droplets. It can sometimes lead to complications such as inflammation of the testicles or ovaries.
Rubella
Rubella, also known as German measles, is a contagious viral infection caused by the rubella virus. It is characterized by a red rash that starts on the face and spreads to the rest of the body. Other symptoms include mild fever, swollen lymph nodes, and joint pain. The rash and other symptoms usually last for about three days. Rubella spreads through respiratory droplets from coughs or sneezes. It is generally a mild infection but can have serious consequences if contracted during pregnancy.