Active not recruitingNAINTERVENTIONAL

ID93/GLA-SE Vaccination + BCG Challenge

Researchers are investigating a new vaccine called ID93/GLA-SE for tuberculosis (TB), a serious lung infection. The main goals are to make sure the vaccine is safe for people who have and haven't had the existing BCG vaccine, and to see how their immune systems respond. The study involves 48 volunteers, some of whom have previously had the BCG vaccine and some who haven't. Participants will receive the new vaccine, and then later, a very small amount of a weakened, safe bacteria similar to TB, called BCG, through a special inhaler. Doctors will take measurements and samples to understand how the body defends itself against this bacteria. This research aims to find better ways to prevent TB, which is currently a major global health challenge.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Oxford

Enrolment target

Start

18 Dec 2024

Estimated completion

01 Jul 2027

Tuberculosis

What is this study about?

Tuberculosis (TB) is a serious infectious disease, mainly affecting the lungs, which is responsible for many deaths worldwide. While we have a vaccine already, called BCG, it works well in children but isn't always effective for adults. This makes finding a new and better vaccine a top priority for scientists around the globe.

Developing a new TB vaccine is tricky because doctors can't safely infect people with real TB to test if a vaccine works. However, scientists have found a clever way around this. They use a weakened form of bacteria, called BCG, which is very similar to TB but doesn't actually cause illness in healthy people. This study uses a special "challenge model" where participants receive a tiny, safe puff of this weakened BCG bacteria into their lungs, much like breathing in the real TB germ. This allows researchers to safely study how new vaccines might prepare the body to fight off TB.

This particular study is looking at a new vaccine called ID93/GLA-SE. Its main aims are to confirm that this new vaccine is safe for people, whether they've had the old BCG vaccine before or not, and to see if it helps their immune system learn to recognise and fight off the TB-like bacteria. By understanding how the body reacts to this safe challenge after getting the new vaccine, researchers hope to gather important information that could lead to a more effective TB vaccine in the future.

Key takeaways

New vaccine ID93/GLA-SE is being tested for safety and immune response against TB.
Study involves receiving the new vaccine and then an inhaled, weakened TB-like bacteria (BCG).
Both people who have had the BCG vaccine and those who haven't are included.
Participation involves blood tests and a procedure called a bronchoscopy.
The study aims to find better ways to prevent tuberculosis.

Who may be eligible?

To join this study, you need to be a healthy adult aged between 18 and 55 years old and live in or very close to Oxford for the entire study period. You'll also need to agree to get a COVID-19 test if needed and be willing to share your medical history with the research team and your GP.

Only people who have *never* smoked (even e-cigarettes) in the last three months are eligible. You also can't have any serious breathing problems like asthma. If you're a woman who could become pregnant, you'll need to use reliable contraception throughout the study and have negative pregnancy tests at key times. You also can't be taking part in another medical study or trial at the same time or have recently participated in one.

Crucially, you'll either need to have had the BCG vaccine in the past (at least a year ago, shown by a scar or records) OR have never had the BCG vaccine before and show no sign of a scar.

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 a healthy adult aged 18-55?
Do you live in or near Oxford for the study's duration?
Have you *not* smoked or vaped in the last 3 months?
Do you have no serious lung conditions like asthma?
Have you either had the BCG vaccine a year ago, or never had it at all?
Are you able to use effective birth control if you could get pregnant?

Answer every question to see your result.

What does participation involve?

If you take part, you'll get the ID93/GLA-SE vaccine. Later, you'll have a special procedure where a very small amount of a weakened, harmless bacteria (BCG) will be vaped into your lungs. Two weeks after this, you'll have a bronchoscopy, which involves looking into your lungs with a thin tube to collect samples to see if any BCG is present. Throughout the study, you'll have regular blood tests to check your immune response and overall health. The specific number of visits and the total length of the study are not fully detailed here, but it involves several appointments over a period of time.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could lead to a new and improved vaccine against a serious global disease like TB. While this study is not designed to directly treat or protect you from TB right now, your participation offers valuable insights. However, there are potential risks, such as side effects from the vaccine, discomfort from blood tests and the bronchoscopy procedure, or reactions to the inhaled BCG. Researchers will explain all known risks in detail. Remember, you can choose to leave 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.

Centre for Clinical Vaccinology and Tropical Medicine
Verified postcode
Oxford, United Kingdom

Common questions

What is BCG and why is it used in this study?

BCG is a very weakened, safe type of bacteria related to TB. It doesn't make healthy people ill. Researchers use it in this study to safely see how your body reacts to something similar to TB, helping them understand if the new vaccine works.

What is a 'bronchoscopy'?

A bronchoscopy is a medical procedure where a thin, flexible tube with a camera on the end is passed through your nose or mouth, down your windpipe, and into your lungs. It allows doctors to look inside and collect small samples. It will be performed 14 days after the BCG challenge.

Will I get TB from participating in this study?

No, you will not get TB. The study uses a very weakened form of bacteria (BCG) that does not cause illness in healthy individuals. The aim is to mimic an infection safely.

Can I smoke or vape during the study?

No, you must not have smoked or vaped (including e-cigarettes) in the last 3 months, and you must agree not to do so for the entire study period.

Will my GP be involved?

Yes, you will need to agree for the researchers to speak with your GP about your medical history.