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Evaluation of two WHO First International Standards for Vi polysaccharide from Citrobacter freundii and Salmonella enterica subspecies enterica serovar Typhi.
- Source :
-
Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2019 Jan; Vol. 57, pp. 34-45. Date of Electronic Publication: 2018 Nov 27. - Publication Year :
- 2019
-
Abstract
- Numerous Vi capsular polysaccharide (Vi PS) conjugate vaccines to protect young children and infants from Typhoid are either licensed or under development. These vaccines are evaluated by laboratory methods to ensure their potency and that quality requirement are met. International Standard (IS) preparations of Vi PS are needed to calibrate and harmonise these assays. Twenty laboratories from 12 countries participated in a collaborative study to evaluate two candidate ISs: Citrobacter freundii Vi PS (NIBSC code 12/244) and Salmonella enterica serovar Typhi Vi PS (16/126). On the basis of returned results and stability profiles, these standards were established by the WHO Expert Committee on Biological Standardization in Oct 2017 as the First WHO IS for C. freundii Vi PS with a content of 1.94 ± 0.12 mg Vi PS per ampoule (expanded uncertainty with coverage factor of k = 2.11 corresponding to a 95% level of confidence) and the First WHO IS for S. Typhi Vi PS with a content of 2.03 ± 0.10 mg Vi PS per ampoule (expanded uncertainty with coverage factor of k = 2.11), as determined by quantitative NMR. The study also showed the ISs are suitable for physicochemical and immuno assays used for the quantitation of the Vi PS component in Vi PS and conjugate vaccines.<br /> (Copyright © 2018. Published by Elsevier Ltd.)
- Subjects :
- Child
Humans
International Cooperation
Magnetic Resonance Spectroscopy
Typhoid Fever prevention & control
Typhoid-Paratyphoid Vaccines administration & dosage
Typhoid-Paratyphoid Vaccines standards
Vaccines, Conjugate administration & dosage
Vaccines, Conjugate immunology
Vaccines, Conjugate standards
World Health Organization
Citrobacter freundii immunology
Polysaccharides, Bacterial immunology
Salmonella typhi immunology
Typhoid Fever immunology
Typhoid-Paratyphoid Vaccines immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1095-8320
- Volume :
- 57
- Database :
- MEDLINE
- Journal :
- Biologicals : journal of the International Association of Biological Standardization
- Publication Type :
- Academic Journal
- Accession number :
- 30502020
- Full Text :
- https://doi.org/10.1016/j.biologicals.2018.11.004