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Clinical and Vaccine Immunology, August 2006, p. 905-912, Vol. 13, No. 8
1071-412X/06/$08.00+0     doi:10.1128/CVI.00014-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Enzyme-Linked Immunosorbent Assay for Measuring Antibodies to Pneumococcal Polysaccharides for the PNEUMOVAX 23 Vaccine: Assay Operating Characteristics and Correlation to the WHO International Assay

Rocio D. Marchese,1* Neil T. Jain,1 Joseph Antonello,2 Laura Mallette,1 Kristin L. Butterfield-Gerson,1 Jennifer Raab,1 Pamela Burke,1 Cheryl Schulman,1 Hilary Adgate,1 Daniel J. Sikkema,1 and Narendra Chirmule1

Vaccine and Biologics Research,1 Vaccine Biometrics Research, Merck Research Laboratories, WYN-1, 466 Devon Park Dr., Wayne, Pennsylvania 19087-86302

Received 13 January 2006/ Returned for modification 1 March 2006/ Accepted 21 April 2006

The Merck pneumococcal (Pn) enzyme-linked immunosorbent assays (ELISAs) for measuring antibodies to 12 serotypes (serotypes 1, 3, 4, 6B, 7F, 8, 9V, 12F, 14, 18C, 19F, and 23F) were validated in 1999. Merck Laboratories developed the Pn assays using 10 µg/ml C polysaccharide, 100 µg/ml Pn polysaccharide (PnPs) 25, and 100 µg/ml PnPs 72 for preadsorption of samples, standards, and controls in order to improve the specificity to the Pn serotypes in the vaccine. The Pn assays utilize postimmunization sera obtained from subjects immunized with PNEUMOVAX 23 as standards for measuring immunoglobulin G concentrations in sera obtained from vaccine clinical trials with adults and infants. This material was calibrated to the Pn reference standard serum, 89SF, subjected to the Merck Pn ELISA adsorbants. Comparisons were made between the Merck Pn assay and the international Pn assay, showing moderate agreement between the two assay formats. This work describes the test procedures and operating characteristics of the Merck Pn assays and the results of experiments performed to compare the Merck Pn ELISAs to the international Pn ELISAs.

* Corresponding author. Mailing address: Vaccine and Biologics Research, Merck Research Laboratories, WYN-1, 466 Devon Park Dr., Wayne, PA 19087-8630. Phone: (215) 652-8492. Fax: (215) 993-1320. E-mail: rocio_marchese{at}merck.com.

Clinical and Vaccine Immunology, August 2006, p. 905-912, Vol. 13, No. 8
1071-412X/06/$08.00+0     doi:10.1128/CVI.00014-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.





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Copyright © 2006 by the American Society for Microbiology. All rights reserved.