Stablepharma's SPVX02 Passes Phase I in 60 Adults, Staying Potent 2 Years at 30C
Updated
Updated · manufacturingchemist.com · Jan 1
Stablepharma's SPVX02 Passes Phase I in 60 Adults, Staying Potent 2 Years at 30C
3 articles · Updated · manufacturingchemist.com · Jan 1
Summary
60 healthy adults in a randomized Phase I trial showed SPVX02 was well tolerated, with no vaccine-related serious adverse events and protective tetanus and diphtheria antibody levels in all participants by day 28.
Two years at 30C and six months at 40C, the fridge-free vaccine retained potency, addressing losses caused by cold-chain failures during storage and transport.
Three cycles between -20C and +40C left SPVX02 fully potent, supporting Stablepharma's claim that its StablevaX process can protect both toxoid antigens and aluminium-based adjuvants from heat and freezing damage.
Phase IIb has already been launched, and Stablepharma expects to complete SPVX02's clinical development by 2027 while extending the platform to hepatitis B, HPV and other temperature-sensitive products.