ArticleVaccines2025
Development and Implementation of a Single Radial Diffusion Technique for Quality Control of Acellular Pertussis Vaccines.
Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
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Who cites it
3 citing papers in PubMed.
- Single Radial Immunodiffusion (SRID) Assay for Quantitative Determination of Recombinant SOD Protein in a Brucellosis Vaccine Candidate: Method Development and Validation.Methods and protocols · 2026Article
- Article
- The Immunogenicity of Glutaraldehyde Inactivated PTx Is Determined by the Quantity of Neutralizing Epitopes.Vaccines · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
BACKGROUND/
objectivesAn assay for protein content is essential but insufficient for quality control of acellular pertussis vaccines, which might consist of up to five components, each needing individual quantification. Generally, purified pertussis antigens such as pertussis toxin (PTx), filamentous haemagglutinin (FHA), and pertactin (PRN) should be detoxified or stabilized chemically before being formulated into vaccine bulk. The use of chemical agents like formaldehyde and glutaraldehyde can alter the immunological reactivity of these antigens, rendering direct assays by methods such as ELISA ineffective.
methodsIn this study, a simple method based on single radial diffusion (SRD) using low concentrations of polyclonal antisera against PT toxoid (PTd), FHA, and PRN was developed. By adding a detergent, diffusible subunits are produced regardless of the original physical state of the antigens, making it suitable for quantifying these antigens after chemical treatment.
resultsThe assay has shown good specificity, accuracy, and precision. Furthermore, it can differentiate between preparations with the same protein concentration but different antigenic contents. A significant positive correlation between the antigen content and the in vivo immunogenicity has also been demonstrated.
conclusionsAn assay for quality control and consistency monitoring of combined vaccines containing acellular pertussis antigen components has been established.
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