About Hepatitis B

Hepatitis B is an inflammatory liver disease caused by the hepatitis B virus (HBV). HBV is easily transferable, especially during birth from mother to child, by sexual contacts and through open wounds, contaminated syringes and accessories. In particular in newborns and young children the infection can become chronic, putting the HBV carrier at risk to develop liver cirrhosis and liver cancer.

The most important things about hepatitis B:

• The hepatitis B virus is transmitted through blood and body fluids
• The main transmission route is mother to child transmission. HBV-replicating mothers are likely to infect their newborns (up to 95%), if no prophylaxis is given.
• In Africa, postnatal infection is frequently observed most likely through wounds or scratches.
• Approximately 90% of HBV-infected infants develop chronic infection, while the majority of adults can eliminate the virus
• The infection in adults becomes chronic in 5 – 10% of cases
• Transmission routes in adults are sexual contacts, contaminated blood products or instruments and drug abuse with contaminated syringes and accessories.
• Prophylactic vaccination can safely prevent hepatitis B.

For more detailed information about hepatitis B disease, prevention, diagnosis and currently available treatments we kindly refer to the Hepatitis B Foundation whom we closely collaborate with.

In case of insecurity about someone’s personal status there are opportunities for the public to get tested for potential HBV infection.
Locations for testing in Europe can be found here.

Can I contribute to / participate in the TherVacB clinical trial as a Hepatitis B patient?

When will the clinical trial start?

The TherVacB clinical trial is planned to start in July 2022.

What is the European registry for patients with chronic Hepatitis B and why is it a good idea to participate?

In addition to the TherVacB clinical trial, the TherVacB team has established a European registry for patients with chronic hepatitis B. The registry collects patient data on virological and immunological parameters during the course of a hepatitis B virus infection. Through a continuously growing collection of patient data, we will be able to gather valuable information on the natural course of the disease and at the same time identify patients for the TherVacB clinical trial as well as other forthcoming studies.

By taking part in the European HBV Registry, you will become patient at one of our participating study centers. They will perform your routine visits and document your data in the registry. This helps selecting patients for participation in specific therapies or clinical trials – including the TherVacB clinical trial.

Last but not least, every participant supports, with the data generated from him- or herself, to better understand the HBV-mediated disease and develop or refine therapies to ultimately help the community of patients in general.

I am a Hepatitis B patient living in Europe. How can I participate?

The European HBV Registry is currently active in Italy, Spain, UK and Germany. In order to participate in the registry, you would have to travel to the study center nearest to you for all routine visits.

Joining the registry is possible at any time and even after the TherVacB vaccination study will have started. Data from TherVacB study participants will be one part of this repository. Patients wishing to join other ongoing or upcoming studies on HBV treatment and cure are also welcome to join.

By reaching out to us, patients with a confirmed interest in participating in the TherVacB vaccination trial or another ongoing or upcoming studies will be referred to a study center closest to the patient’s place of residence/home. The TherVacB study physician will then decide together with the patient on a possible inclusion in the registry, amongst other things based on a set of clinical criteria.

If you are interested in joining the registry, please contact us: Just mark the checkbox and we will get in touch.

All patient data collected through our contact form will be safely stored locally and carefully handled according to consents received, by fully respecting data protection rules (GDPR) in place. If it is planned to collect further data – e.g. for the HBV patient registry – you will be informed separately about the protection of this data and must agree to this beforehand.

When will the therapy be available for patients?

The clinical trial presented above represents an initial safety and efficacy trial in chronically infected hepatitis B patients. If this trial is successful, further clinical phase II and III trials have to follow to complete the clinical development. This is requested routinely for all new medical treatments before they can be approved for routine clinical use.

If TherVacB is efficient and passes all clinical trials and will have proven its capacity to cure HBV, a product launch is expected around 2028.

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