Abstract
Inactivated poliovirus vaccine (IPV) plays an instrumental role in the Global Poliovirus Eradication Initiative (GPEI). The quality of IPV is controlled by assessment of the potency of vaccine batches. The potency of IPV can be assessed by both in vivo and in vitro methods. In vitro potency assessment is based upon the assessment of the quantity of the D-Antigen (D-Ag) units in an IPV. The D-Ag unit is used as a measure of potency as it is largely expressed on native infectious virions and is the protective immunogen. The most commonly used in vitro test is the indirect ELISA which is used to ensure consistency throughout production.
A range of in vivo assays have been developed in monkeys, chicks, guinea pigs, mice, and rats to assess the potency of IPV. All are based on assessment of the neutralizing antibody titer within the sera of the respective animal model. The rat potency test has become the favored in vivo potency test as it shows minimal variation between laboratories and the antibody patterns of rats and humans are similar. With the development of transgenic mice expressing the human poliovirus receptor, immunization-challenge tests have been developed to assess the potency of IPVs. This chapter describes in detail the methodology of these three laboratory tests to assess the quality of IPVs.
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References
Enders JF, Weller TH, Robbins FC (1949) Cultivation of the Lansing strain of poliomyelitis virus in cultures of various human embryonic tissues. Science 109(2822):85–87
Salk JE, Krech U, Youngner JS, Bennett BL, Lewis LJ, Bazeley PL (1954) Formaldehyde treatment and safety testing of experimental poliomyelitis vaccines. Am J Public Health Nations Health 44(5):563–570
Sabin AB (1985) Oral poliovirus vaccine: history of its development and use and current challenge to eliminate poliomyelitis from the world. J Infect Dis 151(3):420–436
Furesz J (2006) Developments in the production and quality control of poliovirus vaccines—historical perspectives. Biologicals 34(2):87–90
Robbins FC (2004) The history of polio vaccine development. In: Plotkin SA, Orenstein WA (eds) Vaccines. Saunders, Philadelphia, pp 17–30
Plotkin SA, Vidor E (2008) Poliovirus vaccine—inactivated. In: Plotkin SA, Orenstein WA, Offit PA (eds) Vaccine. Saunders Elsevier, Philadelphia, pp 605–629
van Wezel AL (1967) Growth of cell-strains and primary cells on micro-carriers in homogeneous culture. Nature 216(5110):64–65
Ferguson M, Wood DJ, Minor PD (1993) Antigenic structure of poliovirus in inactivated vaccines. J Gen Virol 74(Pt 4):685–690
Nathanson N, Langmuir AD (1963) The Cutter incident: poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to Cutter vaccine. Am J Epidemiol 78:29.6–60.6
European Pharmacopoeia, 2.7.20 (2011) In vivo assay of poliomyelitis vaccine (inactivated). In: European Pharmacopoeia 7.0. pp 226–227
Beale AJ, Mason PJ (1962) The measurement of the D-antigen in poliovirus preparations. J Hyg (Lond) 60:113–121
Souvras M, Montagnon BJ, Fanget B, Van Wezel AL, Hazendonk AG (1980) Direct enzyme-linked immunosorbent assay (ELISA) for quantification of poliomyelitis virus D-antigen. Dev Biol Stand 46:197–202
United States Department of Health Education and Welfare (1968) Biological Products Public Health Service, in 42, Public Health Service (ed). Division of Biological Standards National Institutes of Health, Maryland. pp 32–44
Gard S, Wesslen T, Fagraeus A, Svedmyr A, Olin G (1956) The use of guinea pigs in tests for immunogenic capacity of poliomyelitis virus preparations. Arch Gesamte Virusforsch 6(5):401–411
Timm EA, Rope EZ, Mc LI Jr (1958) Chick potency tests of poliomyelitis vaccine: basic studies on response. J Immunol 80(5):407–414
van Steenis G, van Wezel AL, Sekhuis VM (1981) Potency testing of killed polio vaccine in rats. Dev Biol Stand 47:119–128
Wood DJ, Heath AB (1995) A WHO collaborative study of immunogenicity assays of inactivated poliovirus vaccines. Biologicals 23(4):301–311
European Pharmacopoeia (2014) In vivo assay of poliomyelitis vaccine (inactivated): test in rats. In: European Pharmacopoeia 8.0. Strasbourg, France
Martin J, Crossland G, Wood DJ, Minor PD (2003) Characterization of formaldehyde-inactivated poliovirus preparations made from live-attenuated strains. J Gen Virol 84(Pt 7):1781–1788
Taffs RE, Chernokhvostova YV, Dragunsky EM, Nomura T, Hioki K, Beuvery EC, Fitzgerald EA, Levenbook IS, Asher DM (1997) Inactivated poliovirus vaccine protects transgenic poliovirus receptor mice against type 3 poliovirus challenge. J Infect Dis 175(2):441–444
Jason-Moller L, Murphy M, Bruno J (2006) Overview of Biacore systems and their applications. Curr Protoc Protein Sci. Chapter 19:Unit 19 13
Pattnaik P (2005) Surface plasmon resonance: applications in understanding receptor-ligand interaction. Appl Biochem Biotechnol 126(2):79–92
Westdijk J, Brugmans D, Martin J, Van’t Oever A, Bakker WA, Levels L, Kersten G (2011) Characterization and standardization of Sabin based inactivated polio vaccine: proposal for a new antigen unit for inactivated polio vaccines. Vaccine 29(18):3390–3397
Kersten G, Hazendonk T, Beuvery C (1999) Antigenic and immunogenic properties of inactivated polio vaccine made from Sabin strains. Vaccine 17(15–16):2059–2066
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Wilton, T. (2016). Methods for the Quality Control of Inactivated Poliovirus Vaccines. In: MartÃn, J. (eds) Poliovirus. Methods in Molecular Biology, vol 1387. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3292-4_15
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DOI: https://doi.org/10.1007/978-1-4939-3292-4_15
Publisher Name: Humana Press, New York, NY
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