The Platform for Harmonization of Vaccine Adjuvant Testing (PHARVAT)

PHARVAT is a two year collaboration between BPRC, EMVI and the WHO, coordinated by BPRC, with a budget of €300 000, of which EMVI will receive €100 000.

The primary objective is to generate a harmonised procedure to permit pre-clinical selection of vaccine adjuvants throughout Europe, including the new member countries. This will be 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 WHO Global Adjuvant Development Initiative (GADI),

2)      an evaluation of lead procedures in collaboration with TRANSVAC, a consortium of vaccine development infrastructure sites funded under FP7,

3)      a selection of one assay resulting from the TRANSVAC results by the scientific advisory board  and validation by AdjuNet members,

4)      dissemination of the harmonized assay by WHO through its web-sites and conferences.

Such tests will allow the activity / safety of adjuvants to be compared directly and will therefore contribute a major advantage in poverty-related disease (PRD) vaccine development programmes.

In spite of the generation of important information 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 the poverty-related diseases: AIDS, malaria and tuberculosis. These difficult diseases call attention to the importance of new approaches emerging from modern technologies and to the costs of vaccines.

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advantage of naturally occurring, protective immune responses provided by attenuated pathogens, but this approach is no longer applicable as new antigens arising from modern technology are used. Modern antigens are at the same time more specific, less dangerous and less immunogenic, but they also represent the major element of costs of the modern vaccines. These are the reasons why most vaccines developers look for the most appropriate adjuvants, aiming to:

a)      reduce the amount of antigen needed,

b)      improve level and quality of the immune response, while

c)      not compromising the stability of the antigen, and

d)      doing 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 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 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.

EVI is participating in validation of assays for adjuvant screening for PRD vaccines.