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

Warfighters in global regionsendemicto vector-borne diseases,such as malaria,experienceincreased probability of being non-combat casualties. Currently,amalariavaccineis under development that requirescryogenicstorageand transport (-150°C or lower)and therefore does not readily integrate with existingvaccine distribution networks such as the World Health Organization’s Expanded Program on Immunization protocol,which usesa2°C–8°C cold chain for distribution. To enable distribution of the new Plasmodium falciparum sporozoite (PfSPZ)malariavaccineand other futureeukaryoticcell vaccines that requirecryopreservation, new technologies must be developed to enablevialing,cooling, transport,storage,rewarming, dilution,and administration to a patient in acost-effectivemanner. Mainstream’s Passively Regulated Cryogenic(PaRC)vial system forvaccine distribution is described in detail in this proposal. Thesystem passively regulates therate ofcoolingand rewarming of thevaccineto maximizecell survival. The PaRC vialand storagesystem also utilizes advanced liquid nitrogen vapor phase(LNVP)storagerepositoriesand dry shippers thatareableto maintain cryogenic operation for much longer periods of timethan astandard LNVP device dueto theactiveliquid nitrogen (LN2) regeneration.