The robust TherVacB management and coordination framework has been implemented for thorough risk assessment and changes to the work plan timelines as well as overall leadership of scientific activities and clinical trial planning.
Targeted communication and awareness campaigns were carried out in close collaboration with key stakeholders in the project networks. The public website, available in seven languages, features news posts about joint workshops and events, up-to-date information for patient communities, key publications of relevance to TherVacB, the series of HBV Cure FAQ community videos.
Regulatory control and approval aspects of the clinical trial have been continuously addressed, monitored, and coordinated with a focus in this period on: Finalization of the key documents for the clinical trial application (CTA), i.e. clinical trial protocol, investigator’s brochure and investigational medicinal product dossiers. The CTA was submitted via the CTIS portal and approval obtained without any additional requests.
Extension of the stability of all TherVacB vaccine components was achieved in the ongoing stability programs. The current shelf-life of the vaccine components last at least until month 36 and ensures the dosing during the extended project duration.
The European HBV Patient Registry has been further expanded, with now six actively recruiting sites in Germany, Spain, and Italy and two additional sites in the UK that will include patients in the further course of the project.
Up to now a total of 328 have been enrolled in the patient registry, of which 52 patients fulfilled the inclusion criteria for the TherVacB clinical trial. The expansion of the infrastructure and the extension of the laboratory at the African partner site in Tanzania were completed. All processes, including the most important virological and immunological endpoint assays, have been implemented, validated and continuously quality checked and form the basis for the successful implementation and completion of the clinical trial at the African partner site. The study protocol for the HBV screening cohort received ethics approval and the set up of the patient cohort will start in October 2024.
A study on patient recruitment provides first-of-its-kind empirical data on the factors influencing the acceptance of social media recruitment for clinical studies among Hepatitis B patients in Germany. Findings are informative for clinical researchers who are considering recruiting hard-to-reach patient populations via social media.
The baseline set of all necessary study documentation in accordance with all legal and the relevant regulatory guidelines for GCP are in place. The eCRF was developed and optimised and introduced to the initial trial sites. The safety management and the statistical analysis plan are available as well as the data management and data validation plan. All study-relevant documents are collected in the clinical trial master file (CTMF) and for each site in the investigator site file. An updated version of the data management plan was released for the use by the consortium. The data and safety management board (DSMB) was activated including the selection of its chair and the approval of the DSMB charta.
The clinical supplier was mandated for labelling (multi-language), packaging, intermediate storage and shipment of the study medication of TherVacB to the respective clinical trial sites. Study medication for the initial study arms is ready for shipment.
All immune monitoring processes are running and subject to continuous internal and external quality control. Innovative immunoassays to clinically validate novel potential biomarker candidates have been established and the final fit-for-purpose validation is about to be finalized. A GCP-compliant database in which all results of the virological and immunological endpoint analyses can be accessed has been established and is ready for use.
