Intravacc CVB vaccine developed for Provention Bio enters PROVENT clinical study

Intravacc announced that a candidate polyvalent inactivated coxsackievirus B, or CVB, vaccine it developed and manufactured for Provention Bio in less than 36 months, has entered into a first in human Phase I clinical study called PROVENT. Provention Bio selected Intravacc in 2018 to lead product development and manufacturing of clinical study material for Provention's vaccine candidate PRV-101. This CVB vaccine candidate is developed for the intended prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes, or T1D, and celiac disease. Intravacc used its proprietary and regulatory approved Vero cell platform to develop a cGMP-grade viral vaccine production process for the polyvalent CVB vaccine candidate. CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis and otitis. CVB is also the cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation. In addition, persistent CVB infection is significantly associated with the development of T1D and celiac disease. With currently no preventive or disease modifying treatments available for T1D, its complications present a serious unmet medical need and up to 2.3M people may be at risk of T1D globally. PRV-101 has the potential to be the first vaccine to prevent up to approximately 50% of T1D and approximately 20% of celiac disease.