The careful selection of adjuvants is critical to the quality and magnitude of the immune response generated by a particular vaccine. At present, the tools available to allow an informed selection of superior adjuvants and/or formulations are limited and unharmonised. The development of harmonised assays, which can provide benchmarking tools by which new formulations/adjuvants can be assessed/downselected and will allow the comparison of adjuvants/formulations across different studies, is of clear benefit.
The project’s main objective is to determine and establish laboratory assays that can be used to harmonise pre-clinical determination of vaccine adjuvant activity based on:

  1. An in-depth survey and analysis of best practice currently being employed by members of AdjuNet, a network of adjuvant developers, users and researchers affiliated with the World Health Organization (WHO) and Global Adjuvant Development Initiative (GADI)
  2. An evaluation of lead procedures in collaboration with TRANSVAC, a vaccine development infrastructure EC funded under FP7
  3. The selection of a panel of assays resulting from the TRANSVAC findings and validation by AdjuNet members
  4. The dissemination of the harmonised assay by the WHO through its websites and conferences.

Such tests will allow the activity of adjuvants to be compared directly and will therefore constitute a major advantage in Poverty Related Diseases (PRD) vaccine development programmes.

In spite of the generation of important advances in many fields such as immunology, virology, molecular biology and microbiology/parasitology, traditional methods of vaccine development have not produced effective vaccines for prevalent infectious diseases, including HIV/AIDS, malaria and tuberculosis. These complex diseases call attention to the importance of new approaches emerging from modern technologies and to the high cost of vaccine development. Successful efforts in vaccine design in the past have typically taken advantage of naturally occurring, protective immune responses provided by attenuated pathogens, but this approach is, to a certain extent, being superseded as new antigens arising from modern technology are used. Modern antigens are, at the same time, more specific, generally less dangerous and less immunogenic, as well as representing the major element of cost of modern vaccines. These are amongst the main reasons why most vaccine developers look for the most appropriate adjuvants. The selection of an optimal adjuvant aims to:

  1. Reduce the amount of antigen needed
  2. Improve level and quality of the immune response
  3. Not compromise the stability of the antigen
  4. Do no harm to the recipient

It is a demanding set of requirements to provide stable, clinical grade products meeting these needs, but with recent advances in the understanding of immune mechanisms, a range of possibilities now exist for developing products that offer targeted stimulation of the immune system. There are many organisations (private and public) that have entered into Research and Development (R&D) activities concerning new vaccines and/or adjuvants, in Europe and elsewhere. To date the search for innovative adjuvants has not been a priority in EC-funded R&D policies and programmes, yet global efforts need to be better organised and there is an urgent need for harmonised testing and evaluation methods for selecting the most appropriate adjuvants.

The overall strategy of the project is:

  1. Surveying current best practice in global adjuvant R&D
  2. Exploiting the expertise present in the participating organisations to analyse the survey results
  3. Determining the assays that are the most appropriate for comparing adjuvant activities
  4. Disseminating the results via workshops, publications in scientific literature and websites