Vaccines & Vaccination

Biography

Biography: Suzanne L. Elliott

Abstract

Clinical trials are essential for the development of new preventative and therapeutic vaccines in infectious diseases and other therapeutic areas. Trial designs vary based on the nature of the disease; the intended population; the phase of development; the frequency of prime and boost doses; and the length of time associated with follow up activity. Vaccine trial participation is affected by external factors such as the constant community challenge to partake in routine vaccination schedules, and social media commentary by pro- and anti-vaccination advocates, and educational programs on the consequences of non-vaccination. Q-Pharm has undertaken 23 vaccination trials over 13 years. The majority of these trials have been in healthy volunteers for preventative vaccines, with some now registered in Australia and the USA. Recruitability and retention of participants has been impacted by the frequency and timing of prime and boost vaccinations and the duration of follow up. Realistic assessment and understanding of these factors needs to be considered by all parties involved, for early and accurate estimation of participant withdrawal rates and collection of valid data. In Australia, clinical trials involving seasonal vaccines, such as influenza, need to commence early enough to allow immunological responses to be completed before the Southern hemisphere immunisation schedules begin in March/April. Data will be presented that supports our recommendations for establishment of appropriate eligibility and on-trial demands of participants that will enhance recruitment and retention.