Provention Bio announced the initiation of PROVENT (PROtocol for coxsackievirus VaccinE in healthy voluNTeers), a first-in-human study of its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.

CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis, otitis, and hand-foot-mouth disease. CVB is also the leading cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation. CVB infection is significantly associated with the development of T1D and celiac disease.

"The PRV-101 investigational vaccine is specifically designed to prevent autoimmunity by primary prevention of a putative infectious trigger," said Heikki Hy?ty, co-founder of Vactech, MD, Ph.D., Professor of Virology at Tampere University, Finland. "A substantial body of evidence points to the role of CVB as a trigger in the initiation of two common autoimmune diseases, T1D and celiac disease. Based on these data, PRV-101 represents an exciting vaccine candidate to intercept the development of these autoimmune disorders. In addition, it has the potential to target several acute CVB diseases and myocarditis."

PROVENT is a placebo-controlled, double-blind, randomized first-in-human study being conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint is the safety of two dose levels of PRV-101 in healthy adult volunteers provided three administrations with 4-week intervals. Tolerability and immunogenicity will also be evaluated. Results of PROVENT are expected in the second half of 2021.

"Initiation of this first-in-human clinical trial is a significant milestone in full alignment with Provention's foundational vision to seek out autoimmunity early to intercept and prevent debilitating and life-threatening diseases," said Francisco Leon, MD, Ph.D., chief scientific officer, and co-founder, Provention Bio. "We look forward to continuing to advance the development of PRV-101 to determine whether a common autoimmune disease can be delayed or prevented with a vaccine against an infectious trigger. If successful, PRV-101 has the potential to be the first vaccine to prevent CVB and could potentially decrease the incidence of T1D and celiac disease."

CVB is a common, potentially serious infection that damages insulin-producing cells and gut-lining cells, triggering a T-cell immune response that is believed to cause autoimmunity in predisposed individuals. The only persistent infection significantly associated with the development of type 1 diabetes (T1D) and celiac autoimmunity, CVB has been found in the pancreas of ~60% of patients with T1D and the gut of ~20% of patients with celiac disease.

PRV-101 is an investigational polyvalent vaccine being developed for the prevention of acute coxsackievirus B (CVB) infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease. It is specifically designed to prevent autoimmunity by the primary prevention of a putative infectious trigger. PRV-101 has the potential to be the first vaccine to prevent CVB as well as up to ~50% of T1D and ~20% of celiac disease. Patents covering the use of PRV-101 in these indications have been licensed in from Vactech.