Scientific Publications by FDA Staff

Clin Vaccine Immunol 2009 Aug;16(8):1105-12

Statistical approach to estimate vaccinia-specific neutralizing antibody titers using a high throughput assay.

Kennedy R, Pankratz VS, Swanson E, Watson D, Golding H, Poland GA

Because of the bioterrorism threat posed by agents such as variola virus, considerable time, resources, and effort have been put into biodefense preparation. One avenue of this research has been the development of rapid, sensitive, high-throughput assays to validate immune responses to poxviruses. Here we describe the adaptation of a beta-gal reporter based vaccinia-neutralization assay to large scale use in over 1,000 subjects. We also describe the statistical methods involved in analyzing the large quantity of data generated. The assay and its associated methods should prove useful tools in monitoring immune responses to next-generation smallpox vaccines, studying poxvirus immunity and in evaluating therapeutic agents such as vaccinia immune globulin.