Establishing a Novel approach to Plague Vaccine testing - A Feasibility Study of an Attenuated Yersina pestis Vaccine Challenge Model

Summary 

Plague – caused by the bacterium Yersinia pestis – is a historic pandemic disease that still poses a threat today. It remains endemic in several countries across Africa, South America, and Asia, where it can spread from animals to humans. There are concerns about its use in bioterrorism. Despite the need for newer, more effective plague vaccines, generating enough clinical data for their approval is difficult.

We aim to accelerate development of vaccines against Yersinia pestis by creating a human vaccine-challenge study. Although it's unethical to expose healthy people to natural disease-causing bacteria, we propose using weakened vaccine-strain bacteria (from a well-established vaccine called EV76) as a model. This vaccine has been given to millions of people and it has a good safety profile.

Our project aims to lay the groundwork for a proposed future clinical trial, with two packages of work covering public engagement and strain characterisation.

Firstly, we will undertake a programme of public engagement to explore the public attitudes to a proposed challenge study using a weakened version of the plague bacteria. Secondly, we will characterise the EV76 challenge-vaccine, by examining its genetic makeup and how it relates to circulating strains. We will establish partnerships with global collaborators in countries where plague is present, to build a consortium for future clinical trials and surveillance activities.

This project is the first step in evaluating a new model for testing plague vaccines and will help build partnerships for future research.