product candidates

PRV-101

PRV-101 is a polyvalent coxsackievirus B (CVB) vaccine licensed from Vactech, Ltd., which Provention is developing as a potential vaccine for acute coxsackie infection and for the potential prevention of up to 50% of worldwide type 1 diabetes (T1D) cases.

PRV-101 is currently in an IND-enabling stage prior to initiation of first-in-human studies. Provention plans to initiate a clinical program for PRV-101 beginning with Phase 1 safety, tolerability and proof-of-mechanism studies in adults and children, followed by a proof-of-concept study.

Prevention of Acute Coxsackie Infection and T1D


T1D is the end result of immune-mediated destruction of the insulin-producing beta cells of the pancreas and is one of the most common and serious chronic diseases occurring in childhood. CVB infection is very common and is responsible for various symptoms and complications ranging from mild respiratory disease, gastrointestinal disturbances and hand-foot-mouth disease to life-threatening cardiomyopathy and meningitis.

Longitudinal studies of more than 200,000 children studied for up to two decades in Finland by Vactech and its collaborators identified CVB infection as a likely environmental trigger in the onset of T1D and T1D-associated celiac disease. The T1D association with CVB infection has been observed in additional independent cohorts in 15 countries, including North America and Australasia.

Peer-Reviewed Publications

Dunne, J.L., et al, Rationale for enteroviral vaccination and antiviral therapies in human type 1 diabetes, Diabetologia. 2019

Hyöty et al., Developing a vaccine for type 1 diabetes by targeting coxsackievirus B, Expert Rev Vaccines. 2018 Nov 19:1-13

Laitinen et al., Coxsackievirus B1 Is Associated With Induction of beta-Cell Autoimmunity That Portends Type 1 Diabetes, Diabetes. 2014 Feb;63(2):446-55

Oikarinen et al., Virus Antibody Survey in Different European Populations Indicates Risk Association Between Coxsackievirus B1 and Type 1 Diabetes, Diabetes. 2014 Feb;63(2):655-62

Romero. Pediatric Group B Coxsackievirus Infections, Curr Top Microbiol Immunol. 2008; 323:223-39.

Sioofy-Khojine et al., Coxsackievirus B1 infections are associated with the initiation of insulin-driven autoimmunity that progresses to type 1 diabetes, Diabetologia. 2018 May;61(5):1193-1202

Stone et al., A Coxsackievirus B vaccine protects against virus-induced diabetes in an experimental mouse model of type 1 diabetes, Diabetologia. 2018 Feb;61(2):476-481