Dataset Information

Creation, characterization, and assignment of opsonic values for a new pneumococcal OPA calibration serum panel (Ewha QC sera panel A) for 13 serotypes.

ABSTRACT: Pneumococcal conjugate vaccines (PCVs) have been very effective in reducing the disease burden caused by Streptococcus pneumoniae serotypes covered by the current vaccine formulations. However, the incidence of disease caused by serotypes not covered by the vaccine is increasing. Consequently, there are active efforts to develop new PCVs with additional serotypes in order to provide protection against the emergent serotypes. Due to costs and ethical issues associated with performing true vaccine efficacy studies, new PCVs are being licensed based on their immunogenicity, which may be assessed with 2 in vitro assays: enzyme-linked immunosorbent assay (ELISA) for quantitating antibody level and opsonophagocytic assay (OPA) for assessing protective function. While a standardized ELISA has been developed, OPA results from different laboratories can be quite disparate, even among laboratories utilizing the same platform. In order to harmonize OPA data, a recent international collaboration assigned opsonic indices to the US Food and Drug Administration (US FDA) reference serum, 007sp, as well as a panel of US FDA calibration sera. However, due to a low number of aliquots, the availability of these calibration sera is extremely limited. Because calibration sera are critical to establish the performance characteristics of an OPA, a second calibration serum panel was created, comprised of 20 sera collected from adults immunized with the 23-valent polysaccharide vaccine, with 150 to 500 aliquots prepared for each serum. In order to establish consensus OPA values of the 20 sera for the 13 serotypes in 13-valent PCV, the sera were tested by 4 laboratories in an international collaborative OPA study. The 007sp results of 1 laboratory deviated significantly from those obtained by the other laboratories, as well as from previously assigned values. Due to these discrepancies, the consensus values for the calibration sera were determined based on the data from the remaining laboratories. Thus, we were able to create a panel of sera with consensus opsonic values that could be used by outside laboratories to calibrate pneumococcal OPAs. Our results also confirmed findings of a previous study that normalization of OPA results significantly reduces interlaboratory variation, with normalization based on 007sp reducing variation by 43% to 74%, depending on serotype.

SUBMITTER: Burton RL

PROVIDER: S-EPMC5944569 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Creation, characterization, and assignment of opsonic values for a new pneumococcal OPA calibration serum panel (Ewha QC sera panel A) for 13 serotypes.

Burton Robert L RL Kim Han Wool HW Lee Soyoung S Kim Hun H Seok Jee-Hyun JH Lee Sang Heon SH Balloch Anne A Licciardi Paul P Marimla Rachel R Bae Sejong S Nahm Moon H MH Kim Kyung-Hyo KH

Medicine 20180401 17

Pneumococcal conjugate vaccines (PCVs) have been very effective in reducing the disease burden caused by Streptococcus pneumoniae serotypes covered by the current vaccine formulations. However, the incidence of disease caused by serotypes not covered by the vaccine is increasing. Consequently, there are active efforts to develop new PCVs with additional serotypes in order to provide protection against the emergent serotypes. Due to costs and ethical issues associated with performing true vaccine ...[more]

PMID: 29703046

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Project description:Pneumococcal conjugate vaccines (PCVs) have been effective in reducing the disease burden caused by Streptococcus pneumoniae. The first licensed PCV (PCV7) was composed of capsular polysaccharides from seven serotypes. This was followed by PCV10, then PCV13, and currently there are a number of higher valency vaccines in development. As part of licensure, new vaccine iterations require assessment of immunogenicity. Since some antibodies can be non-functional, measuring functional antibodies is desirable. To meet this need, opsonophagocytic assays (OPAs) have been developed. Previous studies have shown there can be significant variations in OPA results from different laboratories. We have previously shown that standardizing OPA data using reference serum 007sp can decrease this variation. To extend this approach to additional serotypes, a panel of sera was tested by five laboratories using a multiplexed OPA for serotypes 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F. Each sample was tested in five runs with 007sp tested three times in each run. Results were analyzed using a mixed effects ANOVA model. Standardization of the results significantly decreased the inter-laboratory variation for some serotypes. For serotypes 2, 8, and 11A, the variability was reduced by 40%, 45%, and 40%, respectively. For serotypes 12F, 17F, and 20B, the reductions were more modest (14%, 19%, and 24%, respectively). Standardization had little effect for the remaining serotypes. In many cases, the impact of normalization was blunted by the results from five sera that were collected after an extended post-vaccination interval. We have previously reported consensus values for 007sp for 13 serotypes, as well as the creation of a calibration serum panel ("Ewha Panel A"). Here, we report consensus values for 11 additional serotypes for 007sp and the creation of a second serum panel ("Ewha Panel B"). These consensus values will facilitate the development of next-generation PCVs.

Dataset Information

Creation, characterization, and assignment of opsonic values for a new pneumococcal OPA calibration serum panel (Ewha QC sera panel A) for 13 serotypes.

Publications

Creation, characterization, and assignment of opsonic values for a new pneumococcal OPA calibration serum panel (Ewha QC sera panel A) for 13 serotypes.

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