relevant Publications

30 December 2024 | JMIR Human Factors, Volume 11

Clinical studies increasingly use social media to recruit participants, yet little research has examined the ethical challenges—especially when targeting individuals in vulnerable situations. This study explores expert and patient perspectives on how social media recruitment can both reduce and amplify vulnerabilities. As part of the international TherVacB EU research project testing a hepatitis B vaccine, the authors conducted 30 interviews with external experts from various fields and 6 patients with hepatitis B. Insights from the study offer practical guidance for minimizing risks while maintaining the benefits of social media recruitment. The study highlights the need for researchers to anticipate ethical challenges and proactively apply strategies that promote both inclusivity and participant protection.

https://humanfactors.jmir.org/2024/1/e52448

17 December 2024 / 10 January 2025 | The Lancet Gastroenterology & Hepatology, Volume 10

In this article, authors call for prioritization to end hepatitis B-related discrimination, taking into account the WHO global hepatitis report 2024.

https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00389-3/abstract

18 December 2024 | The New Yorker

The major U.S. popular media magazine The New Yorker prioritizes hepatitis B and its health disparities in the USA. Hepatitis B Foundation President Dr. Chari Cohen is quoted in a powerful new story about hepatitis B.

https://www.newyorker.com/science/annals-of-medicine/a-cancer-causing-virus-hiding-in-millions-of-americans

This study focuses on patients with hepatitis B in Germany and examines their attitudes toward using social media platforms like Facebook and Twitter for recruiting participants into clinical trials. Hepatitis B is a chronic infectious disease, and patients with this condition are often seen as vulnerable, facing potential stigma and discrimination. Researchers at TherVacB’s TUM-MED and at TUM, University of Bern and University of Basel surveyed 195 patients from three clinical centres in Germany and found that factors like digital literacy, trust in nonmedical sources, privacy concerns, and willingness to share their diagnosis impact their acceptance of social media recruitment. The study emphasizes how understanding these factors, including health technology acceptance, can help researchers design recruitment strategies while balancing ethics and data protection considerations, especially in this vulnerable group. These insights could improve enrolment for clinical studies in the future.

https://www.jmir.org/2024/1/e54034

The increasing use of social media opens new opportunities for recruiting patients for research studies. Based on semi-structured interviews with both people using social media and living with hepatitis B as well as experts in a range of disciplines, authors are exploring the practical benefits of recruiting study participants with social media and are sharing an expert summary on how to conduct social media-based recruitment. Generally, a multiplatform approach with mixed-methods recruitment is the most beneficial recruitment strategy for many research studies. The different recruitment methods complement each other and may contribute to improving the reach of the study, the recruitment accrual, and the representativeness of the sample. Importantly, an assessment of the context- and project-specific appropriateness and usefulness of social media recruitment should be carried out before designing the recruitment strategy.

https://www.jmir.org/2023/1/e44587/

February 2023 | Journal of Hepatology

Induction of potent, HBV-specific immune responses is crucial to control and finally cure HBV. The therapeutic hepatitis B vaccine TherVacB combines protein priming with a Modified Vaccinia virus Ankara (MVA)-vector boost to break immune tolerance in chronic HBV infection. Particulate protein and vector vaccine components, however, require a constant cooling chain for storage and transport, posing logistic and financial challenges to vaccine applications. Authors of this article aimed to identify an optimal formulation to maintain stability and immunogenicity of the protein and vector components of the vaccine using a systematic approach. This will facilitate global vaccine application without the need for cooling chains and is important for the development of prophylactic as well as therapeutic vaccines supporting vaccination campaigns worldwide.

https://www.jhep-reports.eu/article/S2589-5559%2822%2900175-6/fulltext

21 February 2023 | Big Data & Society

Social media advertising is gaining a foothold in the recruitment of clinical study participants, promising more yield per money spent because the technology can better reach highly specialised groups. In this article, authors point out severe societal risks posed by advertising for clinical studies on social media and call for updates of research ethics guidelines and better regulation of Big Data and inferential analytics. In conclusion, social media advertising – especially with vulnerable patient populations – is deemed unsuitable as a recruitment tool for clinical studies as long as the processing of (even anonymised) social media usage data and the training of predictive models by data analytics and artificial intelligence companies is not sufficiently regulated.

https://journals.sagepub.com/doi/10.1177/20539517231156127

This article investigates the potential of CD70 co-expression during viral vector boost vaccination to improve an antigen-specific T cell response. In sum, the article presents a safe system to selectively enhance the vector-vaccine-induced CD8 T cell response to the target antigen through CD70 co-expression during boost immunization. In this respect, this study may contribute to the development and improvement of therapeutic vaccines revealing novel generic design principles and thus foster advances of current strategies to fight malignancies and persistent viral infections.

https://www.mdpi.com/2076-393X/11/2/245

9 de enero de 2023 | Journal of Hepatology
Los autores describen el esquema de vacunación terapéutica heteróloga(TherVacB) desarrollado recientemente, que comprende un cebado de proteína particulada seguido de un refuerzo de vector del virus vaccinia Ankara (MVA) modificado para el tratamiento del VHB. Sin embargo, siguen sin estar claros los determinantes clave necesarios para superar la tolerancia inmunitaria específica del VHB. In this article, new combination adjuvants and unravel factors are studied that are essential for the antiviral efficacy of the TherVacB vaccination scheme.

Lee más sobre el trabajo del equipo en torno a la Prof. Dra. Ulrike Protzer y la Dra. Anna Kosinska aquí: https://idw-online.de/en/news807417
https://www.journal-of-hepatology.eu/article/S0168-8278(22)03465-1/fulltext#secsectitle0045

21 de enero de 2023 | Vacunas – Número especial Vacuna contra el virus de la hepatitis Inmunoterapia
En este artículo, el equipo de investigadores estudia el potencial de la coexpresión de CD70 durante la vacunación de refuerzo con vectores virales para mejorar la respuesta de células T antígeno-específica. En general, este estudio indica que la coexpresión orquestada de CD70 y un antígeno vacunal puede ser un medio interesante y seguro de potenciar las respuestas de células T CD8 específicas de antígeno utilizando vacunas basadas en vectores, aunque en nuestro estudio no fue suficiente para romper la tolerancia inmunitaria.
https://www.mdpi.com/2076-393X/11/2/245

12 de octubre de 2022 | Journal of Hepatology (JHEP) Reports
La vacunación terapéutica es una prometedora opción terapéutica para la hepatitis B crónica que puede permitir curar la hepatitis B crónica. Sin embargo, su aplicación requiere cadenas de refrigeración funcionales durante el transporte y el almacenamiento que difícilmente pueden garantizarse en muchos países con gran demanda. In this study, the authors including Julia Sacherl, Anna D. Kosinska and Ulrike Protzer, developed thermostable vaccine components that are well tolerated and allow inducing immune responses and control the virus in preclinical mouse models even after long-term exposure to high surrounding temperatures. This will lower costs and ease application of a therapeutic vaccine and thus be beneficial for the many hepatitis B patients worldwide.

Lea más sobre el trabajo del equipo del laboratorio del Prof. Protzer aquí: https://www.dzif.de/en/chronic-hepatitis-b-development-thermostable-therapeutic-vaccine.

https://www.jhep-reports.eu/article/S2589-5559(22)00175-6/fulltext

30 de marzo de 2022 | Nature
Elie Dolgin
Unos ciclos finitos de tratamiento podrían controlar el virus, con la combinación adecuada de fármacos.
Sigue leyendo para saber más sobre cómo Ulrike Protzer y Mala Maini, de TherVacB, junto con otros destacados científicos especializados en el VHB, virólogos, inmunólogos víricos y hepatólogos de todo el mundo, han impulsado el desarrollo de un plan de acción centrado en la curación del VHB que incluye las perspectivas de los pacientes.
https://www.nature.com/articles/d41586-022-00812-1

31 July 2021 | Vaccines
Anna D Kosinska, Julia Festag, Martin Mück-Häusl, Marvin M Festag, Theresa Asen, Ulrike Protzer
Durante el curso natural de la infección crónica por el virus de la hepatitis B (VHB), suele perderse el antígeno e de la hepatitis B (HBeAg), mientras que la transmisión directa del VHB HBeAg negativo puede dar lugar a una hepatitis B fulminante. Aunque la inducción de respuestas inmunitarias específicas del VHB mediante la vacunación terapéutica es una opción de tratamiento novedosa y prometedora para la hepatitis B crónica, sigue sin estar claro si la pérdida del HBeAg puede influir en su eficacia o tolerabilidad. We therefore generated an adeno-associated virus (AAV)-vector that carries a 1.3-fold overlength HBV genome with a typical stop-codon mutation in the pre-core region and initiates the replication of HBeAg(-) HBV in mouse livers. Infection of C57BL/6 mice established persistent HBeAg(-) HBV-replication without any detectable anti-HBV immunity or liver damage. HBV-carrier mice were immunized with TherVacB, a therapeutic hepatitis B vaccine that uses a particulate HBV S and a core protein for prime vaccination, and a modified vaccinia Ankara (MVA) for boost vaccination. The TherVacB immunization of HBeAg(+) and HBeAg(-) HBV carrier mice resulted in the effective induction of HBV-specific antibodies and the loss of HBsAg but only mild liver damage. Intrahepatic, HBV-specific CD8 T cells induced in HBeAg(-) mice expressed more IFNγ but showed similar cytolytic activity. This indicates that the loss of HBeAg improves the performance of therapeutic vaccination by enhancing non-cytolytic effector functions.
https://pubmed.ncbi.nlm.nih.gov/34451966/

6 July 2021 | The Pan African Medical Journal
Guenter Froeschl, Michael Hoelscher, Lucas Henze Maganga, Inge Kroidl, Petra Clowes, Steffen Geis, Elmar Saathoff, Dieter Hoffmann, Ulrike Protzer, Arne Kroidl
El África subsahariana tiene una alta prevalencia de infección por el virus de la hepatitis B (VHB). This analysis aims at elucidating the exposure to HBV across different age groups in Mbeya Region in Tanzania and determines prevalence of hepatitis C (HCV) and hepatitis delta antigen (HDV) infections.
https://www.panafrican-med-journal.com/content/article/39/174/full/

17 June 2021 | Der Hausarzt.DIGITAL
Ulrike Protzer
Durante mucho tiempo se realizaron pruebas de hepatitis B y C en la revisión médica. Versicherte ab 35 Jahren können sich einmalig auf diese beiden Erkrankungen untersuchen lassen. Dr. med. Ulrich Scharmer sprach darüber mit der Virologin Prof. Dr. med. Ulrike Protzer, München.
https://www.hausarzt.digital/medizin/praevention/screening-auf-hepatitis-b-und-c-gehoert-jetzt-zur-gesundheitsvorsorge-95051.html

18 March 2021 | Biomolecules
Till Bunse, Anna D. Kosinska, Thomas Michler y Ulrike Protzer
En la infección crónica por el virus de la hepatitis B (VHB), las células T específicas del virus son escasas y parcialmente disfuncionales. Therapeutic vaccination is a promising strategy to induce and activate new virus-specific T cells. In long-term or high-level HBV carriers, however, therapeutic vaccination by itself may not suffice to cure HBV. One reason is the impairment of antiviral T cells by immune checkpoints. In this study, we used small-interfering RNA (siRNA) in combination with a heterologous prime-boost therapeutic vaccination scheme (TherVacB) to interfere with a major immune checkpoint, the interaction of programmed death protein-1 (PD-1) and its ligand (PDL-1). In mice persistently replicating HBV after infection with an adeno-associated virus harboring the HBV genome, siRNA targeting PD-L1 resulted in a higher functionality of HBV-specific CD8+ T cells after therapeutic vaccination, and allowed for a more sustained antiviral effect and control of HBV in peripheral blood and in the liver. The antiviral effect was more pronounced if PD-L1 was down-regulated during prime than during boost vaccination. Thus, targeting PD-L1 using siRNA is a promising approach to enhance the efficacy of therapeutic vaccination and finally cure HBV.
https://www.mdpi.com/2218-273X/12/3/470