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

A first-time-in human (FTIH), Phase I/II, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GSK Biologicals’ HBV viral vector vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tide analogue (NA) therapy.

This study is a first-time test in humans for a new vaccine intended to help people with chronic Hepatitis B. We're looking at adults aged 18 to 65 who are currently taking medication that's keeping their Hepatitis B under control. The main goals are to find out if the vaccine is safe, what side effects it might cause, and if it can trigger a good immune response against the virus. We also want to see if it can help reduce the amount of virus in the body. Participants will receive different doses of the vaccine and be closely monitored for over a year to understand its effects. This is a crucial step in developing new treatments for Hepatitis B.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

Start

26 Mar 2024

Hepatitis B Chronic

What is this study about?

This research study is about trying out a new vaccine for people who have chronic Hepatitis B, a long-lasting liver infection. This is the very first time this specific vaccine is being given to humans, so it's a very early stage of testing. The main aim is to understand thoroughly how safe the vaccine is and if it causes any noticeable side effects. It’s important to find out if people can tolerate it well.

Another key part of the study is to see if the vaccine can help your immune system – your body's natural defense – get better at fighting the Hepatitis B virus. We'll be looking at things like whether your body makes special protecting proteins (antibodies) and immune cells against the virus. We also want to check if the vaccine can help reduce the amount of the virus markers in your blood, which could mean the treatment is working.

Participants in this study are adults between 18 and 65 years old who have chronic Hepatitis B, but are already managing their condition well with their regular medication. The new vaccine, called GSK3528869A, will be given alongside their current treatment. We hope that this research will lead to new ways to help people with Hepatitis B in the future.

Key takeaways

This is a new vaccine being tested for the first time in people with chronic Hepatitis B.
The main goals are to check the vaccine's safety and see if it helps your immune system fight the virus.
Participants must be 18-65 years old and already managing their Hepatitis B with medication.
The study involves multiple clinic visits, injections, and blood tests over approximately 2.5 years.
You will continue your current Hepatitis B medication throughout the study.
You can withdraw from the study at any time without impacting your medical care.

Who may be eligible?

This study is for adults with chronic Hepatitis B who are between 18 and 65 years old. To be able to join, you must already be taking medicine for your Hepatitis B, and this medicine should be working well to control your condition.

Both men and women can take part in this research. The doctors will need to check your medical history and other health information to make sure this study is suitable and safe for you. It's really important that your Hepatitis B is stable and well-managed before you can be considered.

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 between 18 and 65 years old?
Do you have chronic Hepatitis B?
Are you currently taking medication for your Hepatitis B that is controlling your condition well?
Are you able to attend regular clinic appointments for about 2.5 years?
Are you willing to receive injections and have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study vaccine which is given as an injection. This will be given in a series of shots over a period of time. You'll have regular visits to the clinic, where doctors and nurses will monitor your health closely. This includes checking for any side effects, taking blood samples, and perhaps urine samples, to see how your body is reacting to the vaccine and to check your Hepatitis B levels.

The study involves follow-up for a total of nearly two and a half years. You will be monitored very closely for several months after your last vaccination to track any effects. This long follow-up helps the researchers understand the vaccine's long-term safety and how well it works. These regular appointments are vital for gathering all the necessary information.

Potential risks and benefits

There are always potential benefits and risks when taking part in a new medical study. A potential benefit is that the vaccine might help your body fight your Hepatitis B infection more effectively, possibly leading to better control of the virus. However, since this is a new vaccine, there's a risk of unknown side effects, although you will be closely monitored for any reactions. You might experience common side effects like soreness where the injection was given, or flu-like symptoms. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your 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
Belgium
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Unverified
Germany
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Unverified
Spain

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 if not managed.

What does 'first-time-in-human' mean?

It means this is the first time this specific vaccine has been given to people. Researchers are cautiously evaluating its safety and early effects.

Will I still take my regular Hepatitis B medication?

Yes, you will continue to take your current medication for Hepatitis B. The study vaccine is given alongside your existing treatment.

How long will I be involved in the study?

Your participation in the study will last for approximately two and a half years, with regular check-ups and monitoring.

What are the injections I will receive?

You will receive doses of the new study vaccine, which is given as a liquid injection. You might also receive a dummy injection if you're in a comparison group, but you won't know which one you receive.