Prokarium Announces MHRA Acceptance To Run Phase I Trial of Enteric Fever Vaccine
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Prokarium, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received Clinical Trial Authorization (CTA) acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a first-in-human Phase I trial with Entervax™, a bivalent vaccine against enteric fever. Prokarium anticipates dosing of the first subject to begin in the first quarter of 2020.
The trial is part of a collaboration between Prokarium and the Wellcome Trust, which invested £4.6m earlier this year to fund two clinical trials with Entervax™. The MHRA approved trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of Entervax™ in healthy volunteers.
“The Entervax™ CTA is additional validation of our vaccine candidate and underlying technology. Importantly, it brings Entervax™ one step closer to those who need it” said Prokarium’s CEO Ted Fjallman, Ph.D.
The endemic population in low- and middle-income countries (LMICs) is about 5.6 billion of which 1.6 billion are at high-risk of developing a typhoid infection. This is complicated by the spread of an extensively drug resistant (XDR) strain which is creating a growing global demand for new vaccines.
Entervax™ has the potential to provide broader protection for these at-risk individuals in LMICs and travellers to those countries. Following this Phase I trial, Prokarium plans to run a Phase Ib age-descending, dose-escalation study in South Asia.