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

TherVacB_Phase1a: Open phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine candidate in healthy volunteers

This is a very early stage study looking into a new treatment for chronic hepatitis B. It's called "TherVacB" and it's a type of vaccine. For the first time ever, this specific vaccine will be given to healthy people. The main goals are to check if the vaccine is safe and to see if it teaches the body's immune system how to better fight the hepatitis B virus. Doctors hope that this new vaccine could eventually help people living with long-term hepatitis B infection.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

University Medical Center Hamburg-Eppendorf

Enrolment target

Start

28 Oct 2024

Chronic Hepatitis B

What is this study about?

This study is about a new vaccine called TherVacB. It's designed to help people who have chronic hepatitis B, which is a long-term infection of the liver caused by the hepatitis B virus. This isn't a vaccine to prevent you from getting hepatitis B, but rather a treatment vaccine for people who already have it.

This is a 'Phase 1a' trial, which means it's one of the very first times this particular vaccine is being given to humans. The researchers want to carefully check two main things: first, that the vaccine is safe to use in people, and second, whether it can train the body's defence system (called the immune system) to better recognise and fight the hepatitis B virus. Think of it like training your body's soldiers to recognise a specific enemy more effectively.

By understanding how safe the vaccine is and how the body reacts to it, doctors can decide if it's promising enough to be studied in more people and eventually, if it could become a new way to treat chronic hepatitis B. This is an important step in developing new medicines to help manage this condition.

Key takeaways

This is a first-time-in-humans study for a new hepatitis B treatment vaccine.
The main goals are to check the vaccine's safety and how the body's immune system responds.
It's open to healthy volunteers aged 18 and over, both men and women.
It could help find new ways to treat chronic hepatitis B in the future.
Your health would be closely monitored by medical professionals.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to both men and women.

Because this is the very first time the vaccine is being tested in humans, it will involve healthy volunteers, meaning people who do not have chronic hepatitis B. This helps the researchers understand the vaccine's effects without other health issues complicating the results.

There might be other health checks or requirements that only the study doctors can explain fully. If you're interested, it's best to speak with the study team.

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.

Am I at least 18 years old?
Am I generally healthy and do not have chronic hepatitis B?
Am I able to commit to regular clinic visits and tests?
Do I understand that this is a very early stage study?

Answer every question to see your result.

What does participation involve?

The study involves giving the new vaccine to participants. Because it's an early-stage study, you would likely have several visits to the clinic for check-ups, to receive the vaccine, and for blood tests. These tests help doctors monitor your health and see how your body is responding to the vaccine.

You would be carefully watched by the medical team throughout the study. The exact number of visits and the full duration of your involvement isn't specified here, but typically, these early studies might involve several weeks or months of follow-up. You'd be given a full schedule if you considered joining.

Potential risks and benefits

Potential benefits of taking part include helping doctors learn more about chronic hepatitis B and possibly finding a new treatment that could help many people in the future. You would be among the first to receive this new vaccine. As with any new medicine, there might be potential risks such as side effects from the vaccine, similar to a regular flu jab, though serious side effects are carefully monitored. You would be fully informed about any known risks before deciding to take part. Remember, 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 chronic hepatitis B?

Chronic hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus. It can cause serious health problems over time.

What does a 'Phase 1a' study mean?

It means this is the very first time the new vaccine is being given to people. The main goals are to check if it's safe and how the body reacts to it.

Is this vaccine for people who already have hepatitis B?

This particular study in healthy volunteers is to check safety and how the immune system responds before testing it on people who already have chronic hepatitis B.

Will I be given the actual hepatitis B virus in this study?

No, this study gives a vaccine, not the actual virus. Vaccines teach your body to fight the virus without giving you the infection.

What kind of tests will be done?

You can expect regular health checks and blood tests to make sure you're safe and to see how your body reacts to the vaccine.