Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Safety and immune responses after vaccination with two investigational RNA-based vaccines against tuberculosis in healthy volunteers

This study is looking into two new experimental vaccines designed to protect people from tuberculosis, a serious infection. It's an early-stage trial, meaning it's one of the first times these vaccines are being given to humans. Researchers want to make sure they are safe for healthy volunteers. They also want to see if the vaccines help the body's immune system become better at fighting off tuberculosis. If these early tests go well, it could lead to more studies and potentially new ways to prevent this disease in the future. The trial is open to healthy adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

BioNTech SE

Enrolment target

128

Start

13 Mar 2024

Tuberculosis

What is this study about?

This study is about a serious infection called tuberculosis, often shortened to TB. TB usually affects the lungs but can affect other parts of the body too. It can make people very unwell and, if not treated, can be life-threatening. Globally, many people get TB each year, and scientists are always looking for better ways to prevent it.

Currently, there is a vaccine for TB (called BCG), but it doesn't offer complete protection, especially for adults. That's why researchers are trying to develop new and improved vaccines. This particular study is testing two new experimental vaccines that use a technology called 'RNA-based'. This is the same type of technology used in some of the recent COVID-19 vaccines.

The main goal of this study is to check if these two new vaccines are safe for people. Because they are new, this is extremely important. The study also aims to see if the vaccines help the body's defence system (immune system) create a strong response against the bacteria that cause TB. This is a very early stage of vaccine development, often called 'Phase 1', where a small number of healthy volunteers are involved to ensure safety before wider testing can begin.

Key takeaways

Tests new experimental vaccines for TB.
First time these vaccines are used in humans.
Main goals: check for safety and immune response.
Open to healthy adults, aged 18 and above.
Participation involves clinic visits and monitoring.
Helps advance scientific understanding of TB prevention.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should generally be well and not have any serious ongoing health problems.

You must be at least 18 years old to be considered for this study. There is no upper age limit, so adults of any age from 18 upwards can take part, provided they are otherwise healthy.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of healthy adults to understand how the vaccines work across different people.

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?
Do you consider yourself generally healthy?
Are you able to attend regular clinic visits?
Are you comfortable receiving an experimental vaccine?
Are you willing to have blood tests done?
Do you understand this is an early-stage study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in a 'Phase 1' study. This typically means you'll have several visits to the clinic over a period of time. During these visits, you will receive one of the experimental vaccines. Researchers will then carefully monitor your health to check for any side effects and take blood samples to see how your immune system is responding to the vaccine.

You might have physical examinations, questions about how you are feeling, and other tests to make sure you are safe and well throughout the study. The total duration of your participation, including all follow-up visits, will be explained in detail by the study team, but these types of studies often involve several months of observation after the vaccination.

Potential risks and benefits

The potential benefit of taking part in this early study is helping scientists develop new ways to fight a serious disease like tuberculosis. Your involvement could lead to a better understanding of these new vaccines, which might eventually help many people. However, as these are new vaccines, there's always a possibility of unexpected side effects, although study doctors will monitor you very closely. You might experience common vaccine side effects like a sore arm, tiredness, or a mild fever. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Germany

Common questions

What is tuberculosis?

Tuberculosis (TB) is a serious infection, usually affecting the lungs, that can make people very ill if not treated.

What kind of vaccines are being tested?

They are new 'RNA-based' vaccines, similar to the technology used in some COVID-19 jabs.

Why is this study important?

It helps scientists find out if these new vaccines are safe and if they can help our bodies fight against TB, which could lead to better ways to prevent the disease in the future.

Will I get tuberculosis from the vaccine?

No, these vaccines do not contain the live bacteria that cause TB, so they cannot give you the disease.

How long does the study last?

The total time you'd be involved, including follow-up visits, would be explained by the study team, but typically these early studies involve several months.