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7 results on '"Rigsby P"'

1. Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies

Author

Rigsby, P, Beamish, E, Hockley, J, Atkinson, E, Hitri, K, Jones, E, Yang, JS, Qadri, F, Bachtiar, NS, Elias, SC, Goel, A, Mishra, R, Dugyala, R, Pasetti, MF, Meiring, JE, Mbewe, M, Gordon, MA, Pollard, AJ, Logan, A, Rijpkema, S, and group, anti-Vi IgG working

Subjects
0301 basic medicine, Lysine, Applied Microbiology and Biotechnology, GM, Geometric Mean, Serology, 0302 clinical medicine, GCV, Geometric Coefficient of Variation, Immunogenicity, Vaccine, BB, Blocking Buffer, Typhoid, Medicine, Polylysine, 030212 general & internal medicine, Polysaccharide, chemistry.chemical_classification, Poly-l-lysine, biology, Immunogenicity, Polysaccharides, Bacterial, CV, Coefficient of Variation, General Medicine, Antibodies, Bacterial, PLL, poly-l-lysine, ELISA, Antibody, Biotechnology, IgG, Bioengineering, Enzyme-Linked Immunosorbent Assay, AD, Assay Diluent, Typhoid fever, Article, Microbiology, 03 medical and health sciences, Humans, Vi, Elisa method, Typhoid Fever, IU, International Unit, Pharmacology, Vaccines, Conjugate, General Immunology and Microbiology, business.industry, IS, International Standard, Typhoid-Paratyphoid Vaccines, Serum samples, medicine.disease, Vi, capsular Vi polysaccharide, 030104 developmental biology, chemistry, Immunoglobulin G, biology.protein, ECBS, Expert Committee on Biological Standardization, business
Abstract

Typhoid vaccines based on protein-conjugated capsular Vi polysaccharide (TCVs) prevent typhoid in infants and young children. Analysis of the serum anti-Vi IgG response following immunisation against typhoid confirms the immunogenicity of TCVs and forms an important part of the pathway to licensing. Comparative studies could expedite the licencing process, and the availability of a standardised ELISA method alongside the 1st International Standard (IS) 16/138 for anti-typhoid capsular Vi polysaccharide IgG (human) will facilitate this process. To this end, a non-commercial ELISA based on a coat of Vi and poly-l-lysine (Vi-PLL ELISA) was evaluated by 10 laboratories. Eight serum samples, including IS 16/138, were tested in the standardised Vi-PLL ELISA (n = 10), a commercial Vi ELISA (n = 3) and a biotinylated Vi ELISA (n = 1). Valid estimates of potencies relative to IS 16/138 were obtained for all samples in the Vi-PLL ELISA and the commercial ELISA, with good repeatability and reproducibility evident from the study results and concordant estimates obtained by the two ELISA methods. The study demonstrates that the Vi-PLL ELISA can be used in clinical trial studies to determine the immunogenicity of TCVs.

Published
2020

2. Establishment of the first International Standard for human anti-typhoid capsular Vi polysaccharide IgG

Author

Rijpkema, S, Hockley, J, Logan, A, Rigsby, P, Atkinson, E, Jin, C, Goldblatt, D, Liang, H, Bachtiar, N, Yang, J, Goel, A, Ramasamy, V, Pasetti, M, Pollard, A, and Group, Anti-Vi Igg Working

Subjects
Adult, Adolescent, IgG, Enzyme-Linked Immunosorbent Assay, AD, Assay Diluent, Article, GCV, geometric coefficients of variation, Young Adult, Immunogenicity, Vaccine, BB, Blocking Buffer, GM, geometric mean, International standard, Typhoid, Humans, Vi, Typhoid Fever, Polysaccharide, Vaccines, Conjugate, IS, International Standard, Polysaccharides, Bacterial, Typhoid-Paratyphoid Vaccines, CV, coefficient of variation, Middle Aged, Reference Standards, Salmonella typhi, Antibodies, Bacterial, Healthy Volunteers, Immunoglobulin G, ECBS, Expert Committee on Biological Standardization, ELISA
Abstract

Vi capsular polysaccharide (Vi) conjugate vaccines, which can prevent typhoid in infants and young children, are being developed. Comparative immunogenicity studies are facilitated by an International Standard (IS) for human anti-Vi IgG. 16/138, a pool of sera from volunteers which received either Vi conjugate vaccine or plain Vi vaccine, was assessed as an IS alongside U.S. reference reagent Vi-IgGR1, 2011. Samples were tested in a commercial ELISA (n = 7), a standardised ELISA based on biotinylated Vi (n = 7) and in-house ELISAs (n = 7). Valid estimates were obtained for the potency of all samples in the commercial ELISA, and the commutability of 16/138 and Vi-IgGR1, 2011 was evident for the commercial ELISA and in-house ELISAs based on a coating of Vi and protein. The WHO Expert Committee on Biological Standardization established 16/138 as the first IS for anti-Vi IgG with 100 IU per ampoule and assigned 163 IU per vial of Vi-IgGR1, 2011.

Published
2018

7. International Collaborative Study: Evaluation of Proposed International Reference Reagent of Pertussis Antiserum (Mouse) 97/642

Author

Gaines Das, Rose, Xing, Dorothy, Rigsby, Peter, Newland, Penny, and Corbel, Michael

Abstract

A freeze dried preparation of mouse serum in vials coded 97/642 containing antibodies to five pertussis antigens [pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae type 2 and 3 (Fim 2 and 3)] has been assessed for its suitability as an international reference reagent in an international collaborative study by thirteen laboratories in nine countries. This serum has been compared with U.S. Standard Pertussis Antiserum (mouse) Lot No. 1 (US Lot 1), which has been in use since 1995, for antibodies for each antigen. Calibration of the proposed International Reference Reagent of Pertussis Antiserum (pIRR) in terms of US Lot 1 gives results which are broadly consistent between laboratories for antibodies to each antigen, although the between-laboratory differences are larger than those seen for comparison of identical sera. Calibration of two positive control sera in terms of the pIRR gave similar between laboratory variability of estimates to that obtained when the same sera were calibrated in terms of US Lot 1. Overall continuity of estimates is maintained if units are assigned to the pIRR based on its calibration in terms of US Lot 1 in this study. Data presently available indicate that the pIRR is sufficiently stable to serve as a reference reagent. It was therefore recommended, with the agreement of all participants, that the preparation in vials coded 97/642 be established as the First International Reference Reagent for Pertussis Antiserum, mouse, with assigned unitages 16 units of anti-PT per vial, 143 units of anti-FHA per vial and 30 units of anti-PRN per vial based on its calibration in terms of US Lot 1. These unitages are also consistent with calibration of 97/642 in terms of the Japanese preparations JNIH-11 for anti-FHA and of JNIH-12 for anti-PT. Purified antigens for Fim 2 and Fim 3 are not readily available and an arbitrary value of 32 units per vial is suggested for anti-Fim 2 and 3 mixture. These recommendations were agreed by the Expert Committee on Biological Standardization of the World Health Organization.

Published
2001
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