Contract development and manufacturing organization (CDMO) Intravacc, said that a candidate polyvalent inactivated coxsackievirus B (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 (PROtocol for coxsackievirus Vaccine in healthy volunteers).

Provention Bio is a clinical stage biopharmaceutical company, that 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 (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 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. 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 2.3 million people may be at risk of T1D globally. PRV-101 has the potential to be the first vaccine to prevent up to ~50% of T1D and ~20% of celiac disease.

“We are very proud to have been able to successfully complete the contract development and manufacturing project for Provention Bio in such a short period of time and to attribute substantially to the first preventive candidate vaccine for T1D and celiac disease,” said Jan Groen, chief executive officer, Intravacc. “This project provides further validation of Intravacc’s Vero cell platform.”

PROVENT is a placebo-controlled, double-blind, randomized Phase I first-in-human clinical 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.