Advancing a multivalent ‘Pan-anthelmintic’ vaccine against soil-transmitted nematode infections

Zhan, Bin; Beaumier, Coreen M; Briggs, Neima; Jones, Kathryn M; Keegan, Brian P; Bottazzi, Maria Elena; Hotez, Peter J

The lead two candidate Ascaris and Trichuris antigens will then be subjected to protein expression at the 10-20L fermentation scale and large-scale protein purification. In anticipation of generating a target product profile that would focus on vulnerable populations living in helminth endemic areas of low-and middle-income countries, it is likely that only low-cost expression systems such as yeast (e.g., Pichia pastoris or Hansenula polymorpha) or bacteria (e.g., E. coli) would be selected [72] . In addition to production yield, solubility and stability, the expressed proteins would be evaluated for immunogenicity and ability to induce protective immunity in the animal models highlighted above. A process will be developed for technology transfer to a current good manufacturing practices manufacturer in the USA, Europe or possibly a developing country manufacturer. Following a good laboratory practices toxicology study, an investigational new drug application would be prepared and filed with the US FDA prior to Phase 1 clinical testing. These antigens would be evaluated initially as monovalent antigens formulated on alum, possibly together with a second adjuvant such as a toll-like receptor agonist used for other vaccines under development by the Sabin Vaccine Institute Product Development Partnership, such as a synthetic lipid A [73] , E6020 [74] or a CpG oligodeoxynucleotide.