Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

The induction of respiratory immune responses by epicutaneous vaccination with the MMR vaccine

This research is exploring a new way to give the Measles, Mumps, and Rubella (MMR) vaccine. Instead of the typical injection into your muscle or under your skin, this study uses a patch directly on the skin. The main goal is to see if this skin patch method can create a similar protective response in your body, particularly in your nose and throat, compared to the standard injection. We are specifically looking at how your body's immune system, which fights off germs, reacts to measles after three months with the skin patch method. The researchers believe there won't be a big difference in how well it works. This study also looks at other immune responses and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rigshospitalet

Enrolment target

Start

20 Jun 2023

Measles mumps and rubella

What is this study about?

This study is looking into a different way to give the MMR vaccine – the jab that protects against measles, mumps, and rubella. Instead of the usual injection into your arm (either into the muscle or just under the skin), the researchers are trying out a new method where the vaccine is applied to your skin, like a patch. This is called 'epicutaneous vaccination'.

The main aim of this research is to see if this new skin patch method can create the same kind of protective response in your body as the traditional injection. They are particularly interested in seeing how your body's immune system reacts in your airways (like your nose and throat) to protect against measles. They'll be checking specific markers in your body three months after you get the vaccine to compare the two methods. The researchers think that both methods will create similar immune responses.

They will also be looking at other important things, like different types of protective cells and antibodies in your blood and nose. They'll also carefully record any side effects you might experience in the month after getting the vaccine, whether it's by injection or skin patch. This helps them understand how safe and effective this new method might be.

Key takeaways

This study is testing a new way to give the MMR vaccine, using a skin patch instead of an injection.
The main goal is to see if the skin patch creates the same protection in your body as the usual injection.
Researchers will check your immune response, especially in your airways, for at least three months.
The study is for adults aged 18 and over, both men and women.
You would have clinic visits for samples (blood, nose, possibly tonsils) and track any side effects.
Participation could help improve future vaccination methods but carries some risks, and you can withdraw anytime.

Who may be eligible?

This study is open to adults aged 18 and over, and both men and women can take part. There are no upper age limits for who can join.

To be considered for the study, you would need to be generally in good health. Your doctor would help determine if you fit all the specific health criteria for the research.

It's important to remember that not everyone who meets these basic age and gender requirements will be suitable. Other health factors and specific medical history would also be checked by the study team to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend several clinic appointments?
Are you comfortable with blood tests and other sample collections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the MMR vaccine. This would be given either in the standard way, as an injection, or through the new skin patch method. The study team would explain which method you would receive.

Over the course of the study, you would have several visits to the clinic. At these visits, doctors and nurses would take samples, such as blood samples and samples from your nose, to check your immune response. They might also take samples from your tonsils using a gentle brush.

Your participation would involve having these assessments at specific times. You would also be asked to keep track of any side effects you experience for 30 days after getting the vaccine. The total length of your involvement in the study would be at least three months, as they are looking at how your body responds over that period. The exact number of visits and the full duration would be explained by the study team.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as contributing to new knowledge about how vaccines can be given. If the skin patch method proves effective, it could lead to new, potentially less invasive ways to receive important vaccinations in the future. However, there's no guarantee of direct personal benefit from participating. As with any medical procedure, there are potential risks, such as side effects from the vaccine itself (like a fever, rash, or soreness where it was given), or discomfort from blood draws or other sample collections. The study team will monitor you closely for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is the MMR vaccine?

The MMR vaccine protects you against three serious illnesses: Measles, Mumps, and Rubella. It's a very important vaccine for public health.

What does 'epicutaneous vaccination' mean?

It means giving a vaccine by applying it directly to the skin, rather than injecting it with a needle. This study is testing if this method works for MMR.

What is a 'Phase II' study?

Phase II studies are usually the second step in testing a new treatment or vaccine in people. They look at how well it works and its safety in a larger group than initial studies.

Will I know if I'm getting the skin patch or the injection?

The study team will explain how the vaccine will be given to you and what to expect depending on which group you are in. It's important to ask them directly about this.

What kind of 'immune response' are they looking for?

They are looking for signs that your body has created protective antibodies and immune cells that can fight off the measles, mumps, and rubella viruses. They are especially interested in your body's response in the respiratory system.