Passively Regulated Cryogenic (PaRC) Vial System for Vaccine Distribution and Administration

Warfighters in global regions endemic to vector-borne diseases such as malaria experience increased probability of being non-combat casualties. Currently, there is a malaria vaccine under development that requires cryogenic storage and transport (-150C or lower), and therefore does not readily integrate with existing vaccine distribution networks such as the World Health Organizations Expanded Program on Immunization protocol, which uses a 2-8C cold chain for distribution. To enable distribution of the new Plasmodium falciparum sporozite (PfSPZ) malaria vaccine, and other future eukaryotic cell vaccines that require cryopreservation, new technologies must be developed to enable vialing, cooling, transport, storage, re-warming, dilution, and administration to a patient in a cost effective manner. Mainstreams proposed Passively Regulated Cryogenic (PaRC) vial system for vaccine distribution is described in detail in this proposal. The system passively regulates the rate of cooling and re-warming of the vaccine to maximize cell survival. The PaRC vial and storage system also utilizes advanced liquid nitrogen vapor phase (LNVP) storage repositories and dry shippers that are able to maintain cryogenic operation for much longer periods of time than a standard LNVP device due to the active liquid nitrogen (LN2) regeneration.