Mixing is required for uniform reconstitution of filter-dried protein antigens in a single-injection vaccine formulation.

We present here a study of vaccine mixing and release following dissolution of filter-dried model protein and toxoid antigens within a single syringe, filter and needle unit. Release was better for filters made from glass than cellulose. Without additional mixing, uniformity was poor and only 41% of input protein was released from protein filter-dried onto glass fiber. In contrast, adding a simple glass bead and mixing by inversion, 100% release antigen solution was achieved, with uniform concentration at exit from the needle throughout a simulated injection. Adsorption onto alum adjuvant had no detectable effect on vaccine dissolution and mixing. The uniformity and yield of low doses of diphtheria and tetanus toxoid was also improved by mixing, albeit with a lower yield of 60-68%. We conclude that uniformity and mixing should be studied to ensure safety and efficacy of directly reconstituted filter-dried vaccine formulations.
PMID: 30005947 [PubMed - as supplied by publisher]

Source: Vaccine - July 10, 2018 Category: Allergy & Immunology Authors: Thangsupanimitchai N, Edwards AD Tags: Vaccine Source Type: research