Rapid Establishment of a Cold Chain Capacity of -60°C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone

Abstract

ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Figure 1.

A, The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) cold chain depots for vaccine storage and transport and study sites for vaccine administration. B, Arktek phase-change material containers and vaccine racks that were modified for use in STRIVE. The Arktek DF container had 3 sets of vaccine carrier racks that filled the space between the phase-change materials. However, the racks were not used to hold vaccines during STRIVE because using them would have meant removing individual vaccine vials from their package carton, which was not feasible without risking the vaccine going out of storage temperature range. Therefore, the vaccines were packed out in Arktek DF containers in their original boxes of 20 vials. C, CryoQ containers packed to show the interior with coolant packs (left), with a close-up view of syringes containing diluted vaccine packed inside (right). A foam pad was then placed on top of the syringes before the CryoQ container was closed.

Figure 1.

A, The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) cold chain depots for vaccine storage and transport and study sites for vaccine administration. B, Arktek phase-change material containers and vaccine racks that were modified for use in STRIVE. The Arktek DF container had 3 sets of vaccine carrier racks that filled the space between the phase-change materials. However, the racks were not used to hold vaccines during STRIVE because using them would have meant removing individual vaccine vials from their package carton, which was not feasible without risking the vaccine going out of storage temperature range. Therefore, the vaccines were packed out in Arktek DF containers in their original boxes of 20 vials. C, CryoQ containers packed to show the interior with coolant packs (left), with a close-up view of syringes containing diluted vaccine packed inside (right). A foam pad was then placed on top of the syringes before the CryoQ container was closed.

Figure 2.

Temperature of the vaccine compartment of the Arktek DF container during laboratory qualification testing. During the testing, the Arktek DF container was opened 8 times a day, 1 hour apart, and the temperature in the vaccine compartment was continuously monitored. The phase-change material (PCM) appears to have fully melted by 5 days, but since it took approximately 1.5 days after PCM melting for the system to warm to –60°C, the hold time of the –78° PCMs was just under 6.5 days.