The Istituto Superiore di Sanità (ISS) is the leading technical and scientific body of the Italian National Health Service. ISS is the Italian Official Medicine Control Laboratory (OMCL) responsible for testing biological and chemical medicines within the network coordinated by the European Directorate for the Quality of Medicines and Health Care, Strasbourg, Fr (EDQM). The fields in which ISS is active range from medical/veterinary/food safety to technology, therapeutic, epidemiology and environmental issues.
The main tasks in all fields are research, control, certification, inspection, clinical trials and training. ISS is involved in the collaboration and consultation with other institutions responsible for the public health, including the Italian Agency for Drugs (AIFA), the Ministry of Health, regional health authorities, local health agencies and hospitals. ISS provides scientific advice and assessments in the framework of international organisations such as EDQM, WHO, ECDE, EFSA, EMA.
Role of ISS in VAC2VAC
ISS researchers will contribute their expertise to several tasks:
- They will be involved in the development and optimisation of an in vitro assay to determine the antigen content of avian infectious bronchitis vaccine (IBV) (which is widely used in poultry industry), which aims at replacing the current in vivo test. For this purpose, specific monoclonal antibodies will be obtained and characterised.
- ISS will contribute to the development and optimisation of cellular assays to analyse human tick-borne encephalitis virus vaccine (TBEV). In particular, traditional monocyte-derived DC (moDCs) or primary monocytes will be used to assess vaccine-induced activation and maturation of primary APC. In addition, monocyte activation tests will be performed to determine endotoxin content in vaccine preparation.
- Furthermore, as OMCL and as experts are present in the European Pharmacopeia and Biotechnology Working Party, ISS will contribute to the development of a road map for the regulatory acceptance of the consistency approach.
Dr. Laura Campitelli has worked on human and animal influenza research and surveillance and participated in EU projects aimed at developing pandemic vaccines from field isolates to evaluate vaccine efficacy. More recently, the Campitelli research unit has focused on activities concerning batch release of viral vaccines, including the standardisation of release methods, as well as development of alternative potency assays for viral vaccines.
Dr. Eliana Coccia's research unit focuses on the mechanisms of cytokine expression regulation in human dendritic cells (DCs) upon pathogen encounter and the impact of these cytokines on anti-microbial immune response. More recently, Dr. Coccia is testing the strength of an in vitro model, represented by human DCs, for in vitro analysis of the immunogenicity of different vaccine candidates (Mycobacteriun tuberculosis and Staphylococcus aureus).