TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
This study, called TherVacB, is looking for a new way to treat chronic hepatitis B. We're testing a special vaccine in people who are already on medication to control their hepatitis B virus. The vaccine has two main parts given a few weeks apart: an initial injection followed by a booster. Researchers want to find out if this new vaccine is safe and if it helps the immune system to tackle the hepatitis B virus more effectively. This could potentially lead to a cure or better long-term control for people living with chronic hepatitis B.
At a glance
What is this study about?
This research is looking for a new treatment for chronic hepatitis B, a long-lasting liver infection caused by the hepatitis B virus. Many people worldwide live with this condition. While current medications can help control the virus, they usually don't get rid of it completely. This study aims to find a new way to help your body fight off the virus, possibly leading to a complete cure or better long-term health.
The new treatment being tested is called TherVacB. It's a special type of vaccine designed to boost your immune system to better recognise and clear out the hepatitis B virus. This study will involve people who are already taking antiviral medicines to keep their hepatitis B under control. The researchers want to see if adding TherVacB to their current treatment is safe and if it helps their immune system work more effectively against the virus.
This is a "phase 1/2" study, which means it's an early stage of testing. The main goals are to check if the TherVacB vaccine is safe for people to use, and if it triggers a good immune response that could help fight the infection. Understanding these things is a crucial step in developing new and potentially more effective treatments for chronic hepatitis B.
Key takeaways
- Tests a new vaccine (TherVacB) for chronic hepatitis B.
- Aims to improve how your body fights the existing virus.
- For people already taking medication for hepatitis B.
- Checks vaccine safety and immune response.
- Early stage research (Phase 1/2).
Who may be eligible?
To join this study, you need to be an adult between 18 and 70 years old. You must have chronic hepatitis B infection and have been taking medication for at least six months that has successfully lowered the amount of virus in your blood. You also need to be generally healthy apart from your hepatitis B, with normal organ function based on blood tests.
There are also certain reasons why you might not be able to join. For example, if you have other serious liver diseases besides hepatitis B, advanced liver scarring (cirrhosis), a history of liver cancer, or other serious infections at the same time. Women who are pregnant, breastfeeding, or not willing to use contraception cannot take part.
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 to 70 years old?
- Do you have chronic hepatitis B?
- Have you been on hepatitis B medication for at least 6 months with good results?
- Are you generally healthy, with no other major liver problems or serious health issues?
- If you are a woman, are you not pregnant or breastfeeding, and willing to use contraception?
What does participation involve?
If you decide to take part, you will be part of a study that involves 81 people. The study is split into two main parts, and your treatment will depend on which group you are in. Generally, you will receive a series of injections over a few weeks. This will include two doses of a vaccine called HEPLISAV B, given about a month apart. Then, about a month after your second HEPLISAV B dose, you will receive a booster shot called MVA-HBVac. Some groups will also get an additional part of the vaccine called HBcoreAg.
Throughout the study, you will have regular check-ups, blood tests, and physical examinations to monitor your health, how you are reacting to the vaccine, and how your body's immune system is responding. The total duration of your participation in the full study is not specified but generally in clinical trials there is a follow-up period after the last dose.
Potential risks and benefits
Locations (6)
- Investigational Site GUFVerified postcodeFrankfurt, Germany
- Investigational Site UKEVerified postcodeHamburg, Germany
- Investigational Site MHHVerified postcodeHanover, Germany
- Investigational Site Uni LeipzigVerified postcodeLeipzig, Germany
- Investigational Site LMUVerified postcodeMunich, Germany
- Investigational Site TUMVerified postcodeMunich, Germany
Common questions
What is chronic hepatitis B?
It's a long-lasting liver infection caused by the hepatitis B virus. It can lead to serious liver problems over time.
What is a 'therapeutic vaccine'?
Unlike vaccines that prevent disease, a therapeutic vaccine helps your body's immune system fight an existing condition, in this case, chronic hepatitis B.
Will I have to stop my current hepatitis B medication?
No, this study is for people who are already successfully controlling their hepatitis B with their current antiviral medicines. You will continue these medications.
What does 'virally suppressed' mean?
It means the amount of hepatitis B virus in your blood is very low or undetectable because of your medicine.
How long will I be in the study if I join?
The study involves a series of injections over about two months, followed by regular check-ups. The exact total time your participation will last isn't specified in this summary.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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