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Clinical and Vaccine Immunology, August 2009, p. 1105-1112, Vol. 16, No. 8
1071-412X/09/$08.00+0     doi:10.1128/CVI.00109-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Statistical Approach To Estimate Vaccinia-Specific Neutralizing Antibody Titers Using a High-Throughput Assay{triangledown}

Richard Kennedy,1 V. Shane Pankratz,2 Eric Swanson,1 David Watson,2 Hana Golding,3 and Gregory A. Poland1,4*

Mayo Vaccine Research Group, Mayo Clinic, Rochester, Minnesota 55905,1 Division of Biostatistics, Mayo Clinic, Rochester, Minnesota 55905,2 Division of Viral Products, CBER, Food and Drug Administration, Washington, DC,3 Program in Translational Immunovirology and Biodefense, Mayo Clinic, Rochester, Minnesota 559054

Received 10 March 2009/ Returned for modification 19 May 2009/ Accepted 8 June 2009

Because of the bioterrorism threat posed by agents such as variola virus, considerable time, resources, and effort have been devoted to 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 β-galactosidase reporter-based vaccinia virus neutralization assay to large-scale use in a study that included 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 evaluating therapeutic agents such as vaccinia virus immune globulin.

* Corresponding author. Mailing address: Mayo Vaccine Research Group, Mayo Clinic, Guggenheim 611C, 200 First Street SW, Rochester, MN 55905. Phone: (507) 284-4968. Fax: (507) 266-4716. E-mail: Poland.gregory{at}mayo.edu

{triangledown} Published ahead of print on 17 June 2009.

Clinical and Vaccine Immunology, August 2009, p. 1105-1112, Vol. 16, No. 8
1071-412X/09/$08.00+0     doi:10.1128/CVI.00109-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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