The aim of UNISEC is to identify, develop and clinically test the most promising concept for a universal influenza vaccine that can be demonstrated to offer adequate (universal) protection, and that are technically suitable for further development to a marketable product.
To achieve this overall aim, UNISEC has defined six sub-objectives:
- To define a set of criteria concerning technical, immunological and market aspects along which universal influenza vaccine candidates can be evaluated (report, delivery date: month 6).
- To develop innovative formulations and production processes for stable influenza vaccines (prototypes, delivery date: month 48).
- To establish experimental conditions including standardized assays which allow the comparative evaluation of vaccine concepts in animal models and in clinical trials (report, delivery dat: month 18).
- To provide comparable pre-clinical animal model data on various vaccine concepts which can help in the selection of the most promising vaccine candidates for further evaluation (report, delvery date: month 48).
- To evaluate promising vaccine concepts in (SME-driven) clinical trials (report, delivery date 36).
- To disseminate knowledge on UNISEC research during the several pre-registration stages of a universal influenza vaccine (various publication forms for scientific and non-scientific audience, activity throughout project period).
In support of the six objectives listed above, six scientific technical sub-objectives have also been defined. These technical objectives will help focus the technical challenges of the project, and their outcomes are likely to have applications beyond the proposed research program, and have utility for vaccines other than universal influenza vaccines.
- To acquire scientific knowledge on the mechanism of action of new vaccine types such as peptides, conserved proteins or genetic vaccines.
- To acquire knowledge on the efficacy and working mechanism of new adjuvants.
- To develop new formulations and production processes for stable vaccines (these new technologies could potentially also be applied for other instable vaccine or drug products).
- To develop new animal models for testing influenza vaccine concepts that could accelerate the testing of other (influenza) vaccine concepts too.
- To develop a set of correlates of protection that could improve the translation of animal data to humans and would increase the value of pre-clinical animal testing.
- To establish a sustainable European clinical trial vaccine expertise network.