Evidence map›Paper›PMID 40872904›Full record

ArticleVaccines2025

The Immunogenicity of Glutaraldehyde Inactivated PTx Is Determined by the Quantity of Neutralizing Epitopes.

Xi Wang, Xinyue Cui, Chongyang Wu, Ke Tao, Shuyuan Pan, Wenming Wei

Abstract read
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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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

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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

6 authors.

Xi WangLab of Novel Bacterial Vaccines Research and Development, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.
Xinyue CuiLab of Novel Bacterial Vaccines Research and Development, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.
Chongyang WuLab of Novel Bacterial Vaccines Research and Development, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.
Ke TaoEngineering Research Center of Antibodies, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.
Shuyuan PanLab of Novel Bacterial Vaccines Research and Development, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.
Wenming WeiLab of Novel Bacterial Vaccines Research and Development, Department of Research and Development, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China.ORCID 0000-0001-8395-3496

Funding

China National Biotec Group Co.,ltd KTZC1200006B
6 · The paper itself

Abstract

BACKGROUND/

objectivesChemically or genetically detoxified pertussis toxin (PTx) is a crucial antigen component of the acellular pertussis vaccine. Chemical detoxification using glutaraldehyde generally causes significant structural changes to the toxin. However, how these structural changes in PTx affect its antigenic properties remains unclear. Additionally, there is limited knowledge regarding how many alterations in antigenic properties impact immunogenicity.

methodsTo investigate the impact of structural changes on antigenic properties, we developed a sandwich ELISA to quantify the neutralizing epitopes on PTx. Subsequently, we analyzed different PTx toxoid (PTd) preparations with the assay. Additionally, we assessed the immunogenicity of various acellular pertussis vaccine candidates containing these PTd preparations. Finally, the assay was applied to evaluate the consistency of commercial batches of PTx and PTd intermediates.

resultsThe assay demonstrated reasonable specificity, accuracy, and precision, and it was sensitive enough to quantify variations in neutralizing epitopes among different PTd samples that shared the same protein concentration. Importantly, we found a positive correlation between the number of neutralizing epitopes in detoxified PTx and its immunogenicity, indicating that the amount of neutralizing epitopes present determines the immunogenicity of glutaraldehyde-inactivated PTx. Moreover, commercial batches of PTx and PTd intermediates exhibited minor variations in neutralizing epitopes.

conclusionsThese findings have significant implications for developing acellular pertussis vaccines as they highlight the importance of preserving the neutralizing epitopes of PTx during detoxification to ensure the vaccine's effectiveness. This assay is also valuable for the quality control of PTd as it more accurately represents the actual antigenic changes of PTx.

Indexed as

acellular pertussis vaccinesantigenic propertiesglutaraldehyde detoxificationimmunogenicitypertussis toxin

Identifiers

PMID40872904
PMCPMC12390169

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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.