Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A study to see how well CVGBM vaccine works at different doses and how safe it is in patients who had surgery for glioblastoma or astrocytoma

This study is looking into a new vaccine called CVGBM. It's for adults (aged 18 and over) who have undergone surgery for specific brain tumours, known as glioblastoma or astrocytoma, particularly if their tumour has a certain genetic make-up (unmethylated glioblastoma). The main goals are to check how safe the vaccine is for people and to work out the best dose to give. This is one of the first times this vaccine is being given to people, following initial laboratory tests. By finding a safe and effective dose, researchers hope to see if this vaccine could help patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Curevac AG

Enrolment target

Start

24 Mar 2023

Surgically Resected Glioblastoma (GBM) or Astrocytoma with a Molecular Signature of Unmethylated Glioblastoma

What is this study about?

Imagine your body has a special defence system, like a tiny army called the immune system, that fights off invaders like germs. Scientists are always looking for new ways to train this army to fight challenging diseases, such as certain brain tumours.

This particular study is focusing on a new type of 'training' for your immune system, called the CVGBM vaccine. It's designed for adults who have had surgery for a specific, aggressive type of brain tumour called glioblastoma, or a similar one called astrocytoma. The study is particularly interested in tumours that have a certain genetic pattern, which doctors refer to as 'unmethylated glioblastoma' – understanding this detail helps scientists target treatments more effectively.

Because this is a vaccine that hasn't been widely used in people before, the very first step is to make sure it's safe and to find the right amount, or 'dose', to give. This study is doing just that. By carefully testing different doses, researchers hope to discover a safe and potentially effective way to use the CVGBM vaccine to help patients after their surgery. It's an important step in developing new ways to treat these conditions.

Key takeaways

This study is testing a new vaccine called CVGBM for brain tumours.
It's for adults (18+) who have had surgery for specific types of glioblastoma or astrocytoma.
The main aim is to find safe doses and see how well the vaccine works.
This is an early-stage study, meaning it's one of the first times people are receiving this vaccine.
Participation involves regular hospital visits for assessments and vaccine doses.

Who may be eligible?

This study is for adults, meaning anyone 18 years old or older. You could be a man or a woman to take part.

The most important health requirement is that you must have had surgery for a specific type of brain tumour. This includes glioblastoma or a type of astrocytoma. The doctors will also check the genetic details of your tumour to see if it has a specific pattern they are looking for, called 'unmethylated glioblastoma'.

If you've had surgery for one of these brain tumours and are 18 or over, your doctor can check if your particular situation and health history meet all the other detailed requirements for joining this study.

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?
Have you had surgery for a glioblastoma or an astrocytoma brain tumour?
Do you know if your tumour was identified as 'unmethylated glioblastoma'?
Are you able to attend regular hospital visits for the duration of the study?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this usually involves regular visits to the hospital or clinic. During these visits, you might have blood tests, physical examinations, and scans to see how your body is responding and to monitor any side effects. You will receive the study vaccine as planned by the research team.

You would have discussions with the study doctors and nurses about how you are feeling and any changes you notice. There will be initial treatments with the vaccine, followed by a period where your health is checked regularly, even after the main vaccine doses are finished. The total time you would be involved in the study, from your first visit to your last follow-up, can last for several months or even longer, depending on the study plan.

Potential risks and benefits

While we hope this vaccine could be helpful, there's no guarantee it will work for you. Potential benefits might include learning more about your condition and possibly helping researchers find new treatments that could benefit future patients. As with any new treatment, there are potential risks, such as feeling unwell, having reactions at the injection site, or other side effects specific to the vaccine. The study team will explain these in detail. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Netherlands
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Unverified
Belgium

Common questions

What is a vaccine, and how is this different from a flu jab?

A vaccine helps train your body's immune system. This particular vaccine is designed to help your immune system recognise and fight certain brain tumour cells, rather than protecting against infections like the flu.

What does 'Phase I and Phase II' mean?

These are early stages of testing medicines. In Phase I, we mostly check if a new treatment is safe and find the right dose. In Phase II, we start to see if it works as intended, while still checking safety.

Will I know if I'm getting the actual vaccine or something else?

In some studies, people might get a dummy treatment, but in this one, everyone gets the active CVGBM vaccine at different doses. The dose you receive will be decided by the study team.

What is 'glioblastoma' and 'astrocytoma'?

These are types of brain tumours. Glioblastoma is an aggressive type, and astrocytoma is another type of tumour that starts in the brain. The study is for specific cases of these tumours.

What does 'unmethylated glioblastoma' mean?

This refers to a specific genetic feature of the tumour. It helps doctors understand the tumour better and decide which treatments might be most effective. Your doctor can explain if this applies to your previous tumour.