Project 460792

Hepatitis C virus continues to be an enormous global public health problem. Remarkable advances in treatment have made it possible to cure people with simple courses of 1 or a few pills daily for 2-3 months. However, despite these advances, new infections continue to outpace cures. To prevent new infections and achieve the World Health Organization goal of elimination of hepatitis C as a public health threat, development of a hepatitis C vaccine will be required. Attempts to develop vaccines have been challenging because of the enormous diversity of the virus and perhaps even more so because of the huge challenges of conducting trials in populations at risk for hepatitis C infection. The only large vaccine trial to date took 6 years and millions of dollars to study a single vaccine candidate in people at risk for hepatitis C through injection drug use. Despite the huge effort, the trial showed that the vaccine was unfortunately not effective. Repeating this approach for every vaccine candidate is simply not feasible. With the advances in treatment, the prospect of using a controlled human infection model or CHIM has been proposed. In this approach, people are given a vaccine candidate and then they are infected with a known strain of hepatitis C. If the vaccine is effective and they clear the infection, that is ideal, but if not, they are then treated with standard antiviral medications which are over 98% effective. The CHIM model has been used to study vaccines in other infectious diseases like Dengue fever and malaria. However, development of a CHIM protocol requires careful consideration. We propose to hold a small workshop of world experts on hepatitis C vaccine development along with ethicists and community members. The goal of the workshop is to address controversies and develop a template protocol for a hepatitis C CHIM that can be used around the world to further hepatitis C vaccine development.