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Recombinant Lactococcus lactis NZ9000 pNZ8123-HPV16-E7 is an experimental oral live bacterial vaccine developed for the prevention and treatment of human papillomavirus type 16 (HPV-16) associated malignancies, including cervical cancer. The vaccine utilizes a genetically modified, food-grade strain of *Lactococcus lactis* (NZ9000) as a delivery vehicle for the HPV-16 E7 oncoprotein. The E7 gene is carried on the pNZ8123 plasmid vector and its expression is regulated by a nisin-inducible promoter (PnisA) and the SPusp45 secretion signal, allowing for the extracellular production of the antigen. Upon oral administration, the recombinant bacteria interact with the mucosal immune system in the gut to stimulate both humoral and cell-mediated immune responses against the E7 tumor-specific antigen. This candidate has progressed to Phase I clinical testing in Iran, where it has shown a favorable safety profile.
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