Plaque purification as a method to mitigate the risk of adventitious-agent contamination in influenza vaccine virus seeds

Vaccine

Volumn 29, Issue 17, 2011, Pages 3155-3161

  Murata, Haruhiko ^a   Macauley, Juliete ^a   Lewis, Andrew M ^a   Peden, Keith ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Adventitious agent; Influenza vaccine; Plaque purification; Seed virus

Indexed keywords

INFLUENZA VACCINE;

ANIMAL CELL; ARTICLE; CANINE ADENOVIRUS; CANINE ADENOVIRUS 1; CELL STRAIN; CELL STRAIN CV 1; CONTROLLED STUDY; INFLUENZA VIRUS A; NONHUMAN; PRIORITY JOURNAL; PURIFICATION; SEASONAL INFLUENZA; SIMIAN VIRUS 40; UNITED STATES; VACCINE PRODUCTION; VIRAL CONTAMINATION; VIRUS CULTURE; VIRUS INFECTION; VIRUS INFECTIVITY; VIRUS ISOLATION; VIRUS REPLICATION; VIRUS STRAIN;

ANIMALS; CELL LINE; DOGS; DRUG CONTAMINATION; HUMANS; INFLUENZA VACCINES; ORTHOMYXOVIRIDAE; VIRUS CULTIVATION;

EID: 79954578647     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.02.041     Document Type: Article

References (29)

1. Minor P.D. Vaccines against seasonal and pandemic influenza and the implications of changes in substrates for virus production. Clin Infect Dis 2010, 50:560-565.
2. Govorkova E.A., Murti G., Meignier B., de Taisne C., Webster R.G. African green monkey kidney (Vero) cells provide an alternative host cell system for influenza A and B viruses. J Virol 1996, 70:5519-5524.
3. Reina J., Fernandez-Baca V., Blanco I., Munar M. Comparison of Madin-Darby canine kidney cells (MDCK) with a green monkey continuous cell line (Vero) and human lung embryonated cells (MRC-5) in the isolation of influenza A virus from nasopharyngeal aspirates by shell vial culture. J Clin Microbiol 1997, 35:1900-1901.
4. Stevens J., Chen L.M., Carney P.J., Garten R., Foust A., Le J., et al. Receptor specificity of influenza A H3N2 viruses isolated in mammalian cells and embryonated chicken eggs. J Virol 2010, 84:8287-8299.
5. Mochalova L., Gambaryan A., Romanova J., Tuzikov A., Chinarev A., Katinger D., et al. Receptor-binding properties of modern human influenza viruses primarily isolated in Vero and MDCK cells and chicken embryonated eggs. Virology 2003, 313:473-480.
6. Lu B., Zhou H., Chan W., Kemble G., Jin H. Single amino acid substitutions in the hemagglutinin of influenza A/Singapore/21/04 (H3N2) increase virus growth in embryonated chicken eggs. Vaccine 2006, 24:6691-6693.
7. Rocha E.P., Xu X., Hall H.E., Allen J.R., Regnery H.L., Cox N.J. Comparison of 10 influenza A (H1N1 and H3N2) haemagglutinin sequences obtained directly from clinical specimens to those of MDCK cell- and egg-grown viruses. J Gen Virol 1993, 74:2513-2518.
8. Katz J.M., Wang M., Webster R.G. Direct sequencing of the HA gene of influenza (H3N2) virus in original clinical samples reveals sequence identity with mammalian cell-grown virus. J Virol 1990, 64:1808-1811.
9. Robertson J.S., Nicolson C., Bootman J.S., Major D., Robertson E.W., Wood J.M. Sequence analysis of the haemagglutinin (HA) of influenza A (H1N1) viruses present in clinical material and comparison with the HA of laboratory-derived virus. J Gen Virol 1991, 72:2671-2677.
10. Schild G.C., Oxford J.S., de Jong J.C., Webster R.G. Evidence for host-cell selection of influenza virus antigenic variants. Nature 1983, 303:706-709.
11. Gregersen J.P. A risk-assessment model to rate the occurrence and relevance of adventitious agents in the production of influenza vaccines. Vaccine 2008, 26:3297-3304.
12. Hartgroves L.C., Koudstaal W., McLeod C., Moncorge O., Thompson C.I., Ellis J., et al. Rapid generation of a well-matched vaccine seed from a modern influenza A virus primary isolate without recourse to eggs. Vaccine 2010, 28:2973-2979.
13. Makizumi K., Kimachi K., Fukada K., Nishimura T., Kudo Y., Goto S., et al. Timely production of A/Fujian-like influenza vaccine matching the 2003-2004 epidemic strain may have been possible using Madin-Darby canine kidney cells. Vaccine 2008, 26:6852-6858.
14. CDC Update: influenza activity-United States and worldwide, 2003-04 season, and composition of the 2004-05 influenza vaccine. MMWR Morb Mortal Wkly Rep 2004, 53:547-552.
15. Herrera G.A., Iwane M.K., Cortese M., Brown C., Gershman K., Shupe A., et al. Influenza vaccine effectiveness among 50-64-year-old persons during a season of poor antigenic match between vaccine and circulating influenza virus strains: Colorado, United States, 2003-2004. Vaccine 2007, 25:154-160.
16. Neumann G., Kawaoka Y. Reverse genetics systems for the generation of segmented negative-sense RNA viruses entirely from cloned cDNA. Curr Top Microbiol Immunol 2004, 283:43-60.
17. Palese P., Zheng H., Engelhardt O.G., Pleschka S., Garcia-Sastre A. Negative-strand RNA viruses: genetic engineering and applications. Proc Natl Acad Sci USA 1996, 93:11354-11358.
18. Rowe W.P., Baum S.G. Studies of adenovirus SV40 hybrid viruses II. Defectiveness of the hybrid particle. J Exp Med 1965, 122:955-966.
19. Lewis A.M., Prigge K.O., Rowe W.P. Studies of adenovirus-SV40 hybrid viruses. IV. An adenovirus type 2 strain carrying the infectious SV40 genome. Proc Natl Acad Sci USA 1966, 55:526-531.
20. Lewis A.M., Rowe W.P. Isolation of two plaque variants from the adenovirus type 2-simian virus 40 hybrid population which differ in their efficiency in yielding simian virus 40. J Virol 1970, 5:413-420.
21. Murata H., Teferedegne B., Lewis A.M., Peden K. A quantitative PCR assay for SV40 neutralization adaptable for high-throughput applications. J Virol Methods 2009, 162:236-244.
22. Scholtissek C. Stability of infectious influenza A viruses at low pH and at elevated temperature. Vaccine 1985, 3:215-218.
23. Sauerbrei A., Wutzler P. Testing thermal resistance of viruses. Arch Virol 2009, 154:115-119.
24. Poulin D.L., DeCaprio J.A. Is there a role for SV40 in human cancer?. J Clin Oncol 2006, 24:4356-4365.
25. Immunization safety review: SV40 contamination of polio vaccine and cancer 2003, The National Academies Press, Washington, DC. K. Stratton, D.A. Alamario, M.C. McCormick (Eds.).
26. Allander T., Andreasson K., Gupta S., Bjerkner A., Bogdanovic G., Persson M.A., et al. Identification of a third human polyomavirus. J Virol 2007, 81:4130-4136.
27. Gaynor A.M., Nissen M.D., Whiley D.M., Mackay I.M., Lambert S.B., Wu G., et al. Identification of a novel polyomavirus from patients with acute respiratory tract infections. PLoS Pathog 2007, 3:e64.
28. Voeten J.T., Brands R., Palache A.M., van Scharrenburg G.J., Rimmelzwaan G.F., Osterhaus A.D., et al. Characterization of high-growth reassortant influenza A viruses generated in MDCK cells cultured in serum-free medium. Vaccine 1999, 17:1942-1950.
29. Victoria J.G., Wang C., Jones M.S., Jaing C., McLoughlin K., Gardner S., et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol 2010, 84:6033-6040.