Standardisation and Development of Assays for Assessment of Influenza Vaccine Correlates of Protection


The human influenza virus is the causative agent of one of the most critical infectious diseases in the world, causing frequent (seasonal) epidemics as well as pandemics, both of which cause significant morbidity and mortality worldwide.  Influenza virus infects all age groups but children and adults over the age of 65 are most at risk of severe morbidity and mortality., and vaccination is recommended for these age groups.  Vaccination remains the most effective method to control seasonal infections, and the most important strategy to ward off a possible pandemic.  Despite the development and licensure of influenza vaccines along with clinical evidence of their ability to protect against influenza, the potential correlates of protection induced by these vaccines are still not fully elucidated.

The availability of a tool-box of standardised, validated serological assays for human influenza vaccines, agreed and used by key parties in the private and public sector will have tremendous global impact on the research and development (R&D) process, and will pave the way for future investigation and definition of correlates of protection for these vaccines.

The FLUCOP project is supported by the Innovative Medicines Initiative Joint Undertaking (IMI JU), with funding from the European Union’s Seventh Framework Programme.

Major Milestones

The long-term objective of the FLUCOP project is to improve and standardise the existing immunological assays applicable to the definition of correlates of protection in future efficacy trials and, whenever feasible, to develop new assays to better evaluate influenza vaccine immunogenicity.

The ultimate objectives will be achieved through three intermediate objectives:

  1. Achieving standardisation of haemagglutination inhibition (HAI) and virus neutralisation (VN) assays (WP1), as primary objective
  2. Advancing the understanding and application of cell-mediated immunity (CMI) (WP2) and neuraminidase (NA) assays (WP3) as tools for evaluating influenza vaccine performance, as secondary objective
  3. Consideration of new technologies that could to be applied to investigate correlates of protection and population based evaluations of influenza vaccines (WP4), as an exploratory objective