057 Vaccines: The Sanaria experience

Abstract

The Sanaria®PfSPZ Vaccine is a metabolically-active non-replicating whole sporozoite (SPZ) malaria vaccine targeting Plasmodium falciparum (Pf), the human parasite responsible for the majority of the 0.6–1.2 million deaths from malaria annually. The two most significant questions in developing the vaccine were: (1) how to manufacture SPZ that met all regulatory requirements (including asepticity/sterility, potency, purity, stability), and (2) how to administer this vaccine. A clinical manufacturing facility (suite of clean rooms) was constructed and a manufacturing process that combines gametocytes produced in blood cultures with aseptically-reared mosquites, and that lasts 44 days culminating in the processes of radiation-attenuation, mosquito dissection and purification of SPZ was developed. The final steps in vaccine manufacture are formulation of vaccine final product by addition of cryoprotectant, vialing, cryopreservation and storage in liquid nitrogen vapor phase (LNVP). Two phase 1 clinical trials of vaccine have been completed to date. Additionally, 7 clinical trials of cryopreserved challenge product (non-attenuated SPZ that are terminated by drug treatment before clinical symptoms develop) have provided critical data on the viability and infectivity of the cryopreserved SPZ and have begun to address the question of how to administer the vaccine. The LNVP cold chain has delivered material to the 9 clinical trials sites, and additional sites, in the US, Europe and Africa. To date, the phase 1 clinical trials have required modest lot sizes of Source of funding: None declared. Conflict of interest: None declared. ejames@sanaria.com