Manufacturing and preclinical toxicity of GLP grade gene deleted attenuated Leishmania donovani parasite vaccine.

ABSTRACT: Centrin1 gene deleted Leishmania donovani parasite (LdCen1^-/-) was developed and extensively tested experimentally as an intracellular stage-specific attenuated and immunoprotective live parasite vaccine candidate ex vivo using human PBMCs and in vivo in animals. Here we report manufacturing and pre-clinical evaluation of current Good-Laboratory Practice (cGLP) grade LdCen1^-/- parasites, as a prerequisite before proceeding with clinical trials. We screened three batches of LdCen1^-/- parasites manufactured in bioreactors under cGLP conditions, for their consistency in genetic stability, attenuation, and safety. One such batch was preclinically tested using human PBMCs and animals (hamsters and dogs) for its safety and protective immunogenicity. The immunogen

SUBMITTER: Avishek K 

PROVIDER: S-EPMC11199483 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature