The Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL) network was established through a partnership between local Liberian and international partners, including the U.S. National Institutes of Health, World Health Organization and FHI Clinical, to provide sustainable research infrastructure to address diseases of public health importance.
The study team maintained a 91% retention rate in a study of a Chikungunya virus (CHIKV) vaccine, despite study disruptions due to natural disasters, including Hurricane Maria, and political unrest near the sites in five Caribbean countries in a CHIKV endemic region.
To address the urgency of vaccine development during a pandemic, innovative strategies are implemented across study design, regulatory processes, recruitment process and more. In this e-book, we describe some of those innovations and argue for incorporating these into the fabric of clinical trials — to establish a “new normal.”
In a study conducted at 17 sites spanning nine countries in a Zika endemic region of the Americas and Caribbean, timely staffing of contract research associates (CRAs) was enabled by the project team’s network of bilingual resources and knowledge of local hiring practices.
CHIKV outbreaks have occurred in countries in Africa, Asia, Europe, and the Indian and Pacific Oceans. It was found for the first time in the Americas on islands in the Caribbean in 2013 and has spread throughout most of the Americas. It has since been identified in over 60 countries in Asia, Africa, Europe and the Americas. No commercially available vaccine to prevent or medicine to treat CHIKV infection is currently available.
Within a challenging, resource-limited setting, the project team succeeded in reaching FP/FV six weeks after arrival in Sierra Leone and 99.998% accuracy of the planned-to-execute budget.
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