"Fitness for duty": social, organisational and structural influences on the design and conduct of candidate hepatitis C vaccine trials involving people who inject drugs.

Several candidate vaccines for hepatitis C are currently in preclinical development or the early stages of clinical trials. Implementing trials of these vaccines among people who inject drugs will be challenging. Previous research, particularly willingness to participate studies in relation to HIV vaccines in marginalized groups, has focused on the modifiable characteristics of individual participants. This qualitative research with people who inject drugs, health staff and clinicians focuses on social, organisational and structural elements of vaccine trial designs which may exclude or reduce the participation of people who inject drugs. (c) 2010 Elsevier Ltd. All rights reserved.