Screening of Volunteers for Influenza Human Challenge Studies
The high morbidity and mortality associated with both pandemic and seasonal influenza and
the anticipation for future influenza pandemics puts influenza front and center in
infectious disease research. Because the natural history and pathogenesis of human influenza
has not been well characterized and cannot be adequately studied in animal models or with
current in vitro techniques, important questions about influenza pathogenesis can only be
approached through human challenge studies.
Previous human challenge studies have addressed some aspects of the natural history by
evaluating the timing of viral replication, shedding, clinical symptoms, and innate and
adaptive immune responses. Although these studies have provided important information, all
but one was performed prior to 1990. Without exception, these studies had limitations due to
the scope of the study and/or the scientific techniques available at that time.
The primary goal of this study is to collect and store serum and PBMC samples and obtain
clinical and laboratory data from volunteers to determine in advance if they are potentially
eligible to participate in future influenza challenge studies. To accomplish this
objective, up to 1000 subjects will be enrolled in this protocol at the NIH Clinical Center
clinic or day hospital in order to maintain a pool of subjects who have been evaluated and
can be screened for future influenza challenge studies.
Time Perspective: Prospective
Matthew J Memoli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|