ESTUDIAN LA EFICACIA DE NUEVAS VACUNAS ANTIPOLIOVIRUS





ESTUDIAN LA EFICACIA DE NUEVAS VACUNAS ANTIPOLIOVIRUS

(especial para SIIC © Derechos reservados)
El modelo de inmunización y provocación en ratones transgénicos puede ser útil para determinar la inmunogenicidad y la protección conferidas por las nuevas vacunas con virus inactivados cuando el estudio en seres humanos no es posible.
ivanov9.jpg Autor:
Alexander Ivanov
Columnista Experto de SIIC

Institución:
Center for Biologics Evaluation and Research, US FDA


Artículos publicados por Alexander Ivanov
Coautores
Eugenia Dragunsky* Konstantin Chumakov** 
MD, PhD, Center for Biologics Evaluation and Research, US FDA, Rockville, EE.UU.*
PhD, ScD, Center for Biologics Evaluation and Research, US FDA, Rockville, EE.UU.**
Recepción del artículo
13 de Julio, 2006
Aprobación
25 de Julio, 2006
Primera edición
21 de Diciembre, 2006
Segunda edición, ampliada y corregida
7 de Junio, 2021

Resumen
En esta revisión se analizan los abordajes metodológicos para valorar las propiedades protectoras de las nuevas vacunas con poliovirus inactivado (VPI) mediante el uso de ratones transgénicos susceptibles a poliovirus. Las vacunas incluyen una nueva generación de VPI elaborada a partir de cepas Sabin atenuadas (VPIs) así como una combinación de productos que consisten en otros antígenos protectores. Los autores describen sus propios resultados y los datos publicados por otros grupos con la finalidad de brindar una perspectiva completa de esta valoración. La prueba en ratones transgénicos se basa en la inmunización y la provocación (parte funcional de la prueba) e incluye determinación serológica. La comparación de la VPI convencional (VPIc) y de la VPIs de tipo I mostró que la VPIs tipo I tiene una excelente antigenicidad e induce un amplio efecto protector en ratones transgénicos. Se encontró que la VPIs tipo 2 inducía niveles más bajos de anticuerpos neutralizantes y menos protección que la VPIc tipo 2 en la prueba de provocación con el poliovirus salvaje. Los autores concluyen que la prueba en ratones transgénicos para determinar la inmunogenicidad y el efecto protector de la nueva VPIs es un método sustituto eficaz en situaciones en las cuales los trabajos de eficacia clínica en seres humanos son imposibles.

Palabras clave
vacuna contra poliovirus, modelo animal, protección, pruebas serológicas


Artículo completo

(castellano)
Extensión:  +/-8.62 páginas impresas en papel A4
Exclusivo para suscriptores/assinantes

Abstract
This review concerns methodological approaches to assessment of protective properties of new inactivated poliovirus vaccines (IPV) using transgenic mice susceptible to poliovirus. Vaccines include a new generation of IPV that is made from attenuated Sabin strains (sIPV), as well as combination products that include other protective antigens. Authors describe their own results and data published by others in order to present comprehensive picture of this assessment. The transgenic mouse test is based on immunization-challenge (functional part of the test) and includes serological assessment. Comparison of conventional IPV (cIPV) and sIPV of type 1 showed that type 1 sIPV possesses excellent immunogenicity and protectivity in Tg-mice. It was found that sIPV of type 2 induced lower levels of neutralizing antibodies and was less protective than type 2 cIPV against challenge with wild-type poliovirus. Authors conclude that transgenic mouse test for evaluation of immunogenicity and protectivity of new IPVs is an effective surrogate method in situation when clinical efficacy trials in people are impossible.

Key words
poliovirus vaccine, animal model, protectivity, serological tests


Full text
(english)
para suscriptores/ assinantes

Clasificación en siicsalud
Artículos originales > Expertos del Mundo >
página   www.siicsalud.com/des/expertocompleto.php/

Especialidades
Principal: Inmunología
Relacionadas: Bioética, Bioquímica, Infectología, Medicina Interna, Neurología, Pediatría



Comprar este artículo
Extensión: 8.62 páginas impresas en papel A4

file05.gif (1491 bytes) Artículos seleccionados para su compra



Enviar correspondencia a:
Alexander Ivanov, Center for Biologics Evaluation and Research, US FDA, MD 20852, 1401 Rockville Pike, Rockville, EE.UU.
Bibliografía del artículo
1. Center for Diseases Control and Prevention. Global Progress toward certifying polio eradication and laboratory containment of wild polioviruses, 2003. MMWR Morb Mortal WKLY Rep 2003, 52:1158-1160.
2. Dowdle WR, De Gourville E, Kew OM, Pallansch MA, Wood DJ. Polio eradication: the OPV paradox. Rev Med Virol 2003; 13:277-291.
3. Wood DJ, Sutter RW, Dowdle WR. Stopping poliovirus vaccination after eradication:issues and challngees. Bull World Health Organ 2000; 78:347-357.
4. World Health Organization (WHO). WHO global action plan for laboratory containment of wild polioviruses. 2nd ed. Geneva: WHO, 2002.
5. Doi Y, Abe S, Yamamoto H, et al. Progress with inactivated poliovirus vaccine derived from the Sabin strains. Dev Biol (Basel) 2001; 105:163-169.
6. . Dragunsky E, Gardner D, Taffs R, Levenbook I. Transgenic PVR Tg-1 mice for testing of poliovirus type 3 neurovirulence: comparison with monkey test. Biologicals 1993, 21:233-237.
7. Dragunsky E, Taffs R, Chernokhvostova Y, Nomura T, Hioki K, Gardner D, Norwood L, Levenbook I. Poliovirus-susceptible transgenic mouse model as a possible replacement of the monkey neurovirulence test for oral poliovirus vaccine. Biologicals 1996, 24:77-86.
8. Dragunsky E, Chernokhvostova Y, Taffs R, Chumakov K, Gardner D, Asher D, Nomura T, Hioki K, Levenbook I. TgPVR21 mice for testing type-3 oral poliovirus vaccines: role of clinical observation and histological examination. Vaccine 1997, 1:1863-1866.
9. Dragunsky E, Nomura T, Karpinski K, Furesz J, Wood DJ, Pervikov Y, Abe T, Kurata T, Vanloocke O, Karganova G, Taffs R, Heath A, Ivshina A, Levebook I. Transgenic mice as an alternative to monkeys for the neurovirulence test of live oral poliovirus vaccine: validation by a WHO collaborative study. Bulletin of the WHO 2003; 81(4):251-260.
10. Dragunsky E, Ivanov A, Abe S, Rezapkin G, Potapova S, Wells V, Ivshina A, Enterline J, Hashizume So, Chumakov K. Evaluation of immunogenicity and protective properties of Inactivated Poliovirus Vaccine: A new surrogative method for predicting vaccine efficacy. J Infect Dis 2004; 190:1404-1412.
11. Levenbook I, Dragunsky E, Chumakov K, Taffs R, Chernokhvostova Y, Nomura T, Hioki K, Gardner D, Cogan J, Asher D. Transgenic mice and a molecular assay as alternatives to the monkey neurovirulence test of oral poliovirus vaccine. In: "Animal Alternatives, Welfare and Ethics", ed. L.F.M. van Zutphen and M. Balls. Elsevier Science B.V. 1997, p. 1013-1016.
12. Levenbook I, Dragunsky E, Pervikov Y. Development of a transgenic mouse neurovirulence test for oral poliovirus vaccine: international collaborative study 1993-1999. Vaccine 2001; 19(2-3):163-166.
13. Ren R, Costantini F, Gorgacz EJ, Lee JJ, Racaniello VR. Transgenic mice expressing a human poliovirus receptor: a new model for poliomielitis. Cell 1990, 63:352-362.
14. Koike S, Taya S, Kurata T, Abe S, Ise I, Yonekawa H, Nomoto A. Transgenic mice susceptible to poliovirus. Proc Natl Acad Sci USA 1991, 88:951-955.
15. Horie H, Koike S, Kurata T, Saito-Yoshida Y, Ise I, Ota Y, Abe S, Hioki K, Kato H, Taya C, Nomura T, Hashizume S, Yonekawa H, Nomoto A. Transgenic mice carrying the human poliovirus receptor: new animal model for study of poliovirus neurovirulence. J Virol 1994, 68:681-688.
16. Abe S, Ota Y, Doi Y, Nomoto A, Nomura T. Chumakov KM, Hashizume S. Studies on neurovirulence in poliovirus-sensitive transgenic mice and cynomolgus monkeys for the different temperature-sensitive viruses derived from the Sabin type 3 virus. Virology 1995, 210:160-166.
17. Abe S, Ota Y, Koike S, Kurata T, Horie H, Nomura T, Hashizume S, Nomoto A. Neurovirulence test for oral live poliovaccines using poliovirus-sensitive transgenic mice. Virology 1995, 206:1075-1083.
18. World Health Organization (WHO). Maintenance and distribution of transgenic mice susceptible to human viruses. Bull World Health Organ 1993; 71:497-509.
19. Dragunsky E, Ivanov A, Abe S, Potapova S, Enterline J, Hashizume So, Chumakov K. Further development of new transgenic mouse test for evaluation of immunogenicity and protective properties of inactivated poliovirus vaccine. JID 2006 - in press.
20. Ivanov AP and Dragunsky EM. ELISA as a possible alternative to the neutralization test for evaluating the immune response to poliovirus vaccines. Expert Rev Vaccines 2005; 4(2):167-172.
21. Lamb GA, Plexico K, Glezen WP, Chin TDY. Use of microtechnique for serum neutralization and virus identification. Public Health Rep 1965; 80:463-466.
22. World Health Organization (WHO). Manual for the virological investigation of polio [WHO/EPI/GEN97.01]. Geneva: WHO, 1997.
23. Hagenaars AM, Van Delft RW, Nagel J, Van Steenis G, and Van Wezel AL. A modified ELISA technique for the titration of antibodies to polio virus as an alternative to a virus neutralization test. J Virol Methods 1983; 6:233-239.
24. Rezapkin G, Dragunsky E, Chumakov K. Improved ELISA test for determination of potency of Inactivated Poliovirus Vaccine (IPV) Biologicals, 2005; 33:17-27.
25. Rezapkin G, Martin J, Chumakov K. Analysis of antigenic profiles of inactivated poliovirus vaccine and vaccine-derived polioviruses by block-ELISA method. Biologicals 2005; 33:29-39.
26. Edevåg G, Wahren B, Osterhaus ADME, Sundquist V-A, and Grandström M. Enzyme-linked immunosorbent assay-based inhibition test for neutralizing antibodies as an alternative to the neutralization test in tissue culture. J Clin Microbiol 1995; 33:2927-2930.
27. Herremans MMPT, Reimerink JHJ, Ras A, Van der Avoort HGAM, Kimman TG, Van Loon AM, Conynn-Van Spaendonk MAE, and Koopmans MPG. Evaluation of a poliovirus-binding inhibition assay as an alternative to the virus neutralization test. Clin Diagn Lab Immunol 1997; 4:659-664.
29. Hashido M, Horie H, Abe S, Doi Y, Hashizume S, Agboatwala M, Isomura S, Nishio O, Hagiwara A, and Inouye S. Evaluation of an enzyme-linked immunosorbent assay based on binding inhibition for type-specific quantification of poliovirus neutralization-relevant antibodies. Microbiol Immunol 1999; 43:73-77.
29. Ivanov AP, Dragunsky EM, Ivanova OE, Rezapkin GV, Potapova SG, Chumakov KM. Poliovirus-binding inhibition ELISA for evaluation of immune response to oral poliovirus vaccine: a possible alternative to the neutralization test. Human Vaccines 2005; 1(3):102-105.
30. Klasse PJ and Sattentau QJ. Mechanisms of virus neutralization by antibodies. Curr Top Microbiol Immunol 2001; 260:87-108.
31. Ivanov AP, Tkachenko EA, Petrov VI et al. Enzyme immuno assay for the detection of virus specific IgG and IgM antibody in patients with HFRS. Arch Virol 1988; 100:1-7.
32. Ivanov A, Dragunsky E, Ivanova O, Rezapkin G, Potapova S, Chumakov K. Determination of poliovirus-specific IgA in saliva of oral poliovirus vaccine recipients by three ELISA tests. J Virol Meth 2005; 126:45-52.
33. Valtanen S, Roivainen M, Piirainen L, Stenvik M, Hovi T. Poliovirus-specific intestinal antibody responses coincide with decline of poliovirus excretion. J Infect Dis 2000; 182:1-5.
34. Samoilovich E, Roivainen M, Titov LP, Hovi T. Serotype-specific mucosal immune response and subsequent poliovirus replication in vaccinated children. J Med Virol 2003; 71:274-280.
35. Hammon WM, Coriell LL, Wehrle PF, Stokes J Jr. Evaluation of Red Cross gamma globulin as a prophylactic agent for poliomyelitis. IV. Final report of results based on clinical diagnises. JAMA 1953; 151:1272-1285.

 
 
 
 
 
 
 
 
 
 
 
 
Está expresamente prohibida la redistribución y la redifusión de todo o parte de los contenidos de la Sociedad Iberoamericana de Información Científica (SIIC) S.A. sin previo y expreso consentimiento de SIIC.
ua31618