Vaccine comprising aluminium adjuvant having low levels of contaminating heavy metal ions

摘要

Protein vaccines comprising aluminium adjuvant and methods to prepare them are disclosed wherein an aluminium salt is selected (e.g. by selecting a particularly contaminating metal free commercial batch) such that when formulated into an aqueous vaccine composition comprising aluminium and a protein that vaccine composition comprises less than 350 ppb heavy metal w/v in the aqueous solution. The preparation of a Japanese Encephalitis virus (JEV) vaccine comprising less than 3 ppb copper and less than 350 ppb heavy metals is disclosed and the stability of the vaccine is demonstrated to be better than when the heavy metal concentration exceeds 350 ppb.