A Thermostable Tetanus/diphtheria (Td) Vaccine in the Stablevax™Pre-Filled Delivery System

ABSTRACT A pre-filled syringe for the long-term, room-temperature storage and injection of vaccines is described. Stabilisation was achieved by drying from a trehalose-containing buffer which formed an inert soluble glass distributed in the internal interconnected voids in a compliant reticulated medical-grade sponge. The sponge is stored inside the barrel of the syringe and the vaccines are re-solubilised by the aspiration of water. The syringe contains the sponge throughout the filling and drying processes in manufacture, and in transport, stockpiling and finally injection. The active vaccine is delivered to the patient in the normal injection process by depressing the plunger, which compresses the sponge to completely expel the dose. There was full recovery of vaccine potency, after 7-10 months @ 45°C, as shown by complete protection against active toxins in immunised Guinea pigs.