Evidence map›Paper›PMID 33162203›Full record

ArticleVaccine2020

Assignment of opsonic values to pneumococcal reference serum 007sp and a second pneumococcal OPA calibration serum panel (Ewha QC sera panel B) for 11 serotypes.

Robert L Burton, Han Wool Kim, Soyoung Lee, Hun Kim, Jee-Hyun Seok, Kun Young Ku, Jihye Seo, Sun Jin Kim, Jinfu Xie, Debra McGuinness and 6 more

Abstract read
In one paragraph

Article in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Robert L BurtonDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Han Wool KimDepartment of Pediatrics, Ewha Womans University College of Medicine, Seoul, Republic of Korea; Center for Vaccine Evaluation and Study, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
Soyoung LeeDepartment of Pediatrics, Ewha Womans University College of Medicine, Seoul, Republic of Korea; Center for Vaccine Evaluation and Study, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
Hun KimBio R&D Center, SK bioscience, Seongnam-Si, Gyeonggi-do, Republic of Korea.
Jee-Hyun SeokBio R&D Center, SK bioscience, Seongnam-Si, Gyeonggi-do, Republic of Korea.
Kun Young KuDepartment of Biopharmaceuticals R&D, LG Chem, Seoul, Republic of Korea.
Jihye SeoDepartment of Biopharmaceuticals R&D, LG Chem, Seoul, Republic of Korea.
Sun Jin KimDepartment of Biopharmaceuticals R&D, LG Chem, Seoul, Republic of Korea.
Jinfu XieInfectious Diseases/Vaccines, Merck & Co., Inc., Kenilworth, NJ, USA.
Debra McGuinnessInfectious Diseases/Vaccines, Merck & Co., Inc., Kenilworth, NJ, USA.
Julie M SkinnerInfectious Diseases/Vaccines, Merck & Co., Inc., Kenilworth, NJ, USA.
Seuk Keun ChoiEuBiologics Co., Ltd, Chuncheon, Republic of Korea.
Yeong Ok BaikEuBiologics Co., Ltd, Chuncheon, Republic of Korea.
Sejong BaeDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Moon H NahmDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Kyung-Hyo KimDepartment of Pediatrics, Ewha Womans University College of Medicine, Seoul, Republic of Korea; Center for Vaccine Evaluation and Study, Ewha Womans University College of Medicine, Seoul, Republic of Korea. Electronic address: kaykim@ewha.ac.kr.

Funding

Acquired deficiency of innate immunity (ficolin-2) among elderly adultsR01AG050607 · NIA · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI NAHM, MOON H. · 2015 to 2019
$1.6M
NIAID NIH HHS HHSN272201200005CNIAID NIH HHS N01 AI030021NIA NIH HHS R01 AG050607
6 · The paper itself

Abstract

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.

Indexed as

Pneumococcal InfectionsStreptococcus pneumoniaeAntibodies, BacterialCalibrationHumansPneumococcal VaccinesSerogroupVaccines, ConjugateAntibodies, BacterialPneumococcal VaccinesVaccines, Conjugate007spOpsonophagocytic assayPneumococcusQuality control seraStandardizationVaccines

Identifiers

PMID33162203
PMCPMC7704772

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.