Multiplex immunoassay for in vitro characterization of acellular pertussis antigens in combination vaccines |
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| Affiliation: | 1. Novartis Vaccines and Diagonstics SrL (a GSK Company), Via Fiorentina 1, 53100 Siena, Italy;2. Università degli Studi di Padova, 35129 Padova, Italy;3. Università di Siena, 53100 Siena, Italy;4. GlaxoSmithKline (former Novartis Vaccines), 350 Massachusetts Ave, Cambridge, 02139 MA, USA;1. Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China;2. Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China;3. Shenzhen Kangtai Biological Products Co., LTD., Shenzhen 518057, Guangdong, China;4. Guangxi Provincial Centers for Disease Control and Prevention, Nanning 530028, Guangxi, China;1. Institute of Veterinary Pathology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland;2. Division of Swine Medicine of the Department for Farm Animals, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland;3. Division of Veterinary Epidemiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland;1. Laboratorio VacSal, Instituto de Biotecnología y Biología Molecular (IBBM), Facultad de Ciencias Exactas, Universidad Nacional de La Plata, CCT-CONICET La Plata, Calles 50 y 115, 1900 La Plata, Argentina;2. Instituto de Estudios Inmunológicos y Fisiopatológicos (IIFP), Facultad de Ciencias Exactas, Universidad Nacional de La Plata, CCT-CONICET La Plata, 47 y 115, 1900 La Plata, Argentina;1. Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Australia;2. Murdoch Childrens Research Institute, Royal Childrens Hospital, Parkville, Australia;3. School of Mathematics and Statistics, The University of Melbourne, Parkville, Australia;4. National Centre for Immunisation Research and Surveillance, The Children''s Hospital at Westmead, Westmead, Australia;1. Laborartorio VacSal, Instituto de Biotecnología y Biología Molecular, Facultad de Ciencias Exactas, Universidad Nacional de La Plata, CCT La Plata CONICET, Argentina;2. Laboratorio de Investigaciones del Sistema Inmune, Facultad de Ciencias Exactas, Universidad Nacional de La Plata, Argentina;3. Laboratorio Central Subsecretaría de Salud de Neuquén, Neuquén, Argentina;1. Center for Infectious Disease Control, National Institute of Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands;2. Emory University, Rollins School of Public Health, Grace Crum Rollins Building, 1518 Clifton Road, Atlanta, GA 30322, USA;3. Laboratorium voor Infectieziekten, Van Swietenlaan 2, 9728 NZ Groningen, The Netherlands;4. Groene Hart Ziekenhuis, Graaf Florisweg 77-79, 2805 AH Gouda, The Netherlands |
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| Abstract: | Vaccines characterization is required to ensure physical, chemical, and biological integrity of antigens and adjuvants. Current analytical methods mostly require complete antigen desorption from aluminum-based adjuvants and are not always suitable to distinguish individual antigens in multivalent formulations. Here, Luminex technology is proposed to improve the analytics of vaccine characterization. As proof of concept, TdaP (tetanus, diphtheria and acellular pertussis) combination, adjuvanted with aluminum hydroxide, was chosen as model formulation to quantify and determine the level of adsorption of acellular pertussis (aP) antigens onto adjuvant surface at the same time. The assay used specific antibodies bound to magnetic microspheres presenting unique digital signatures for each pertussis antigen, allowing the simultaneous recognition of respective antigens in the whole vaccine, avoiding laborious procedures for adjuvant separation. Accurate and reproducible quantification of aP antigens in TdaP vaccine has been achieved in the range 0.78–50 ng/mL, providing simultaneously information on antigen identity, quantity, and degree of adsorption to aluminum hydroxide. The current study could further be considered as a model to set up in vitro potency assays thus supporting the replacement of animal tests accordingly to the 3Rs concept. |
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| Keywords: | Luminex technology Multiplex Aluminum hydroxide Combination vaccine Acellular pertussis aP" },{" #name" :" keyword" ," $" :{" id" :" kw0035" }," $$" :[{" #name" :" text" ," _" :" acellular pertussis AlOH" },{" #name" :" keyword" ," $" :{" id" :" kw0045" }," $$" :[{" #name" :" text" ," _" :" aluminum hydroxide TdaP" },{" #name" :" keyword" ," $" :{" id" :" kw0055" }," $$" :[{" #name" :" text" ," _" :" tetanus–diphtheria–acellular pertussis vaccine TT" },{" #name" :" keyword" ," $" :{" id" :" kw0065" }," $$" :[{" #name" :" text" ," _" :" tetanus toxoid DT" },{" #name" :" keyword" ," $" :{" id" :" kw0075" }," $$" :[{" #name" :" text" ," _" :" diphtheria toxoid PT" },{" #name" :" keyword" ," $" :{" id" :" kw0085" }," $$" :[{" #name" :" text" ," _" :" -9K/129Ggenetically detoxified pertussis toxin FHA" },{" #name" :" keyword" ," $" :{" id" :" kw0095" }," $$" :[{" #name" :" text" ," _" :" filamentous haemagglutinin PRN" },{" #name" :" keyword" ," $" :{" id" :" kw0105" }," $$" :[{" #name" :" text" ," _" :" pertactin |
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