16 November 2022
To advance the ambitious programme of Inno4Vac, which aims to harness the latest advances in immunology and disease modelling for tackling persistent scientific bottlenecks in vaccine development and for de-risking and accelerating this process, an Annual Meeting was held for all involved partners. The Inno4Vac 1st Annual Meeting took place on 5 and 6 October 2022, in Siena, Italy, and allowed approximately 120 participants to present, discuss, and drive the project forward.
All four interlinked subtopics of the project took part:
Subtopic 1 (VAXPRED), in which artificial intelligence in combination with big data analysis and computational modelling is being used to build an open-access and cloud-based platform for in silico vaccine efficacy assessment and development.
Subtopic 2 (CHIMICHURRI) is developing new and improved controlled human infection models (CHIM) against influenza, RSV and Clostridium difficile that will enable early vaccine efficacy evaluation.
Subtopic 3 (MERMAID) contributes to the development of cell-based human in vitro 3D models that resemble the in vivo situation of an infection at the mucosa and more reliably predict immune protection. These models are being combined with the development of related functional immune assays for clinically relevant (surrogate) endpoints.
Subtopic 4 (VAXinS) is developing a modular one-stop computational platform for in silico modelling of vaccine bio-manufacturing and stability testing.
In addition to the scientific-technical work, Inno4Vac partners are developing strategies and roadmaps for positioning the newly developed models in the regulatory framework and integrating them into pharmaceutical vaccine development. During the meeting, numerous action points were tackled and some of the most important outcomes are described below:
The discussion between Subtopic 1 (VAXPRED) partners was very productive during the VAXPRED workshop, organised in Siena at GSK Campus, and during the Inno4Vac Annual Meeting. The key topics addressed were the available methods for modelling and quantifying the heterogeneous baseline of the human adaptive immune system, as well as predicting B-cell epitopes. The agile process development method was presented during the meeting and its use was activated in order to organise in-silico open-access and cloud-based platform functionality.
Subtopic 2 (CHIMICHURRI) has held in-depth scientific discussions on the characterisation of the challenge agents for respiratory viruses (Influenza, RSV) and C. difficile for manufacturing and clinical study design. The annual meeting provided a productive space to align with Subtopics 1 and 3 on samples and data requirements to progress on cross-activities, and partners have offered future support to tackle identified gaps. Key knowledge on challenge agents GMP manufacturing processes was shared. As the Subtopic 2 aims for CHIM model implementation within the vaccine development pipeline on a global scale, as well as its regulatory acceptance, a full alignment was much needed on the future interactions and opportunities with regulatory experts and bodies: key scientific guidance ahead of the start of the clinical studies and manufacturing activities is critical. It was agreed to focus on workshops preparations within Q2 2023. These aim to connect with national ethics committees (including patient advocacy groups), FDA, EMA and international experts, in order to attain ethical approval in the countries where the organisation of the Inno4Vac CHIM trials will take place as well as for the regulatory acceptance for the data of the trials to facilitate licensure registration.
Subtopic 3 (MERMAID) is in the “development stage” of creating in vitro models to reliably predict immune protection and develop them to de-risk vaccine development and enter the regulatory space. This subtopic is rapidly approaching a critical stage gate, and this meeting allowed developers and industry partners to meet and discuss how best to determine which applications and features each of the 16 models currently being worked on will need, in order to pass through to stage two – the “exploratory stage” of the project. This was the first opportunity for early career researchers from groups across Europe working on Subtopic 3 to interact in person and discuss work-in-progress, leading to fruitful debates and feedback for the next year of experiments. More progress was made on how best to drive the models towards regulatory acceptance, and key topics to cover at next year’s regulatory meeting were identified. In addition, important discussions and alignment occurred between groups in Subtopic 2 and Subtopic 3 working on C. difficile, RSV and influenza, leading to decisions on which samples and data sharing methods to use, to best leverage expertise within the consortium.
Subtopic 4 (VAXinS) has made progress in generating an overall in silico model that connects all major steps in vaccine manufacturing, including upstream and downstream processing. Advances were made in modelling of bioreactors via computational fluid dynamics, building digital twins of purification processes (centrifugation and chromatography), as well as process control and product stability prediction, and importantly, integrating these in an online platform. Experimental data, real-life data, mathematical models, and the validation of these was discussed in depth and key decisions on next steps were made. Regulatory expert advice was sought in every step to make vaccine development and manufacture pipelines more reliable, affordable, flexible, and safe.
The progress of the meeting can also be seen on Twitter and LinkedIn posts (see below).
The meeting included two keynote lectures, by Rino Rappuoli (GSK) on The Miracle of COVID-19 Vaccines and the Trillion Dollar Gap, and Geert Leroux Roles (Ghent University) on Harmonisation and qualification of assays to measure cell-mediated immune responses to influenza vaccines.
Participants of the Inno4Vac 1st Annual Meeting (October 5-6th, 2022, University of Siena, Italy).
The first Inno4Vac annual meeting was an important accelerator for Inno4Vac as a whole, by bringing together the entire consortium and allowing most efficient exchange and progress – in a historic venue, University of Siena.
Dr. Irina Meln (Project and Innovation Manager at the European Vaccine Initiative)
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (www.imi.europa.eu). This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.