Implementing a vaccine trial during an epidemic can be difficult, particularly in countries with poor transportation, limited vaccine supplies and difficulty predicting how widespread a disease may become — conditions such as those in West Africa during the recent Ebola outbreak.
Now, a University of Florida researcher with colleagues from several other academic institutions have outlined three principles for these studies in a Perspectives paper published April 2 in the journal Science.
The paper outlines three methods for deploying vaccine trials in emergency situations for infectious diseases such as Ebola, cholera, meningococcal meningitis, Middle East respiratory syndrome, dengue fever, chikungunya, and new strains of flu. Vaccines have the potential to prevent people from contracting these diseases, stopping the spread of infection.
“This discussion began back in October when different vaccine trial designs were being debated in the World Health Organization and a vaccine trial system was being set up. At that time, the Ebola epidemic was peaking,” said Dr. Ira Longini, a co-author of the article and co-director of the Center for Statistics and Quantitative Infectious Diseases in the Emerging Pathogens Institute at UF. “This was an effort to try to get these vaccines through phase 1 and 2 testing for safety and into the field for efficacy on a very accelerated basis. It typically takes months, if not years, to design these trials.”
Dr. Longini, a professor in the UF College of Public Health and Health Professions and the College of Medicine, said the article is an attempt to understand and clarify some of the possible trial designs. Dr. Longini is currently in Geneva, helping design vaccine trials.