Application of real time RT-PCR for the genetic homogeneity and stability tests of the seed candidates for live attenuated influenza vaccine production

Journal of Virological Methods

Volumn 195, Issue , 2014, Pages 18-25

  Shcherbik, Svetlana ^a,b   Sergent, Sheila B ^a,b   Davis, William G ^a,b   Shu, Bo ^a   Barnes, John ^a   Kiseleva, Irina ^c   Larionova, Natalie ^c   Klimov, Alexander ^a   Bousse, Tatiana ^a  

^a NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES   (United States)

^b BATTELLE MEMORIAL INSTITUTE   (United States)

^c INSTITUTE OF EXPERIMENTAL MEDICINE   (Russian Federation)

Author keywords

Homogeneity test; Influenza virus; Live vaccine; Real time RT PCR; Reassortants

Indexed keywords

HEMAGGLUTININ; INFLUENZA VACCINE; SIALIDASE;

ARTICLE; DRUG SAFETY; GENE SEQUENCE; GENETIC REASSORTMENT; GENETIC STABILITY; GENOTYPE; IMMUNE RESPONSE; INFLUENZA VIRUS; INFLUENZA VIRUS A; INFLUENZA VIRUS B; PRIORITY JOURNAL; QUALITY CONTROL; REAL TIME POLYMERASE CHAIN REACTION; RNA ISOLATION; SENSITIVITY AND SPECIFICITY; SEQUENCE ANALYSIS; VACCINE PRODUCTION; VIRUS GENOME; VIRUS STRAIN;

HOMOGENEITY TEST; INFLUENZA VIRUS; LIVE VACCINE; REAL TIME RT-PCR; REASSORTANTS;

ANIMALS; CHICK EMBRYO; GENETIC VARIATION; GENOMIC INSTABILITY; HUMANS; INFLUENZA VACCINES; ORTHOMYXOVIRIDAE; QUALITY CONTROL; REAL-TIME POLYMERASE CHAIN REACTION; TECHNOLOGY, PHARMACEUTICAL; VACCINES, ATTENUATED; VIROLOGY;

EID: 84887232726     PISSN: 01660934     EISSN: 18790984     Source Type: Journal    
DOI: 10.1016/j.jviromet.2013.09.003     Document Type: Article

References (39)

1. Aleksandrova G.I. Use of the genetic recombination method for obtaining vaccinal strains of the influenza virus. Voprosy Virusologii 1977, 4:387-395.
2. Ambrose C.S., Levin M.J., Belshe R.B. The relative efficacy of trivalent live attenuated and inactivated influenza vaccines in children and adults. Influenza and Other Respiratory Viruses 2011, 5:67-75.
3. An W.Q., Yang P.H., Duan Y.Q., Luo D.Y., Tang C., Jia W.H., Xing L., Shi X.F., Zhang Y.J., Liu X.F., Wang X.L. Generation and characterization of a cold-adapted attenuated live H3N2 subtype influenza virus vaccine candidate. Chinese Medical Journal 2009, 122:2880-2885.
4. Buonagurio D.A., Bechert T.M., Yang C.F., Shutyak L., D'Arco G.A., Kazachkov Y., Wang H.P., Rojas E.A., O'Neill R.E., Spaete R.R., Coelingh K.L., Zamb T.J., Sidhu M.S., Udem S.A. Genetic stability of live, cold-adapted influenza virus components of the FluMist/CAIV-T vaccine throughout the manufacturing process. Vaccine 2006, 24:2151-2160.
5. Chen W., He B., Li C., Zhang X., Wu W., Yin X., Fan B., Fan X., Wang J. Real-time RT-PCR for H5N1 avian influenza A virus detection. Journal of Medical Microbiology 2007, 56:603-607.
6. Cox R.J., Brokstad K.A., Ogra P. Influenza virus: immunity and vaccination strategies. Comparison of the immune response to inactivated and live, attenuated influenza vaccines. Scandinavian Journal of Immunology 2004, 59:1-15.
7. Deng Y.M., Caldwell N., Barr I.G. Rapid detection and subtyping of human influenza A viruses and reassortants by pyrosequencing. PLoS ONE 2011, 6:e23400.
8. Desselberger U. Relation of virus particle counts to the hemagglutinating activity of influenza virus suspensions measured by the HA pattern test and by use of the photometric HCU method. Archives of Virology 1975, 49:365-372.
9. Donald H.B., Isaacs A. Some properties of influenza virus filaments shown by electron microscopic particle counts. Journal of General Microbiology 1954, 11:325-331.
10. Emery S.L., Erdman D.D., Bowen M.D., Newton B.R., Winchell J.M., Meyer R.F., Tong S., Cook B.T., Holloway B.P., McCaustland K.A., Rota P.A., Bankamp B., Lowe L.E., Ksiazek T.G., Bellini W.J., Anderson L.J. Real-time reverse transcription-polymerase chain reaction assay for SARS-associated coronavirus. Emerging Infectious Diseases 2004, 10:311-316.
11. Fiore A.E., Bridges C.B., Cox N.J. Seasonal influenza vaccines. Current Topics in Microbiology and Immunology 2009, 333:43-82.
12. Fulvini A.A., Ramanunninair M., Le J., Pokorny B.A., Arroyo J.M., Silverman J., Devis R., Bucher D. Gene constellation of influenza A virus reassortants with high growth phenotype prepared as seed candidates for vaccine production. PLoS ONE 2011, 6:e20823.
13. Ha S.H., Kim H.A., Kim Y.H., Kim J.S., Lee K.H., Park S.Y., Park W.J., Seong B.L. A multiplex RT-PCR method for screening of reassortant live influenza vaccine virus strains. Journal of Virological Methods 2006, 134:154-163.
14. Huprikar J., Rabinowitz S. A simplified plaque assay for influenza viruses in Madin-Darby kidney (MDCK) cells. Journal of Virological Methods 1980, 1:117-120.
15. Isaacs A. Particle counts and infectivity titrations for animal viruses. Advances in Virus Research 1957, 4:111-158.
16. Kaida A., Kubo H., Shiomi M., Kohdera U., Iritani N. Evaluation of real-time RT-PCR compared with conventional RT-PCR for detecting human metapneumovirus RNA from clinical specimens. Japanese Journal of Infectious Diseases 2008, 61:461-464.
17. Kiseleva I.V., Larionova N.V., Teley L.C., Rudenko L.G. [Restriction analysis of genome composition of live influenza vaccine]. Voprosy Virusologii 2011, 56:28-32.
18. Klimov A.I., Cox N.J. PCR restriction analysis of genome composition and stability of cold-adapted reassortant live influenza vaccines. Journal of Virological Methods 1995, 52:41-49.
19. Lee E.Y., Lee K.H., Jung E.J., Jang Y.H., Seo S.U., Kim H.A., Seong B.L. Genotyping and screening of reassortant live-attenuated influenza B vaccine strain. Journal of Virological Methods 2010, 165:133-138.
20. Maassab H.F., Bryant M.L. The development of live attenuated cold-adapted influenza virus vaccine for humans. Reviews in Medical Virology 1999, 9:237-244.
21. Maassab H.F., DeBorde D.C. Development and characterization of cold-adapted viruses for use as live virus vaccines. Vaccine 1985, 3:355-369.
22. Monne I., Ormelli S., Salviato A., De Battisti C., Bettini F., Salomoni A., Drago A., Zecchin B., Capua I., Cattoli G. Development and validation of a one-step real-time PCR assay for simultaneous detection of subtype H5, H7, and H9 avian influenza viruses. Journal of clinical microbiology 2008, 46:1769-1773.
23. Murphy B.R., Coelingh K. Principles underlying the development and use of live attenuated cold-adapted influenza A and B virus vaccines. Viral Immunology 2002, 15:295-323.
24. Nakauchi M., Yasui Y., Miyoshi T., Minagawa H., Tanaka T., Tashiro M., Kageyama T. One-step real-time reverse transcription-PCR assays for detecting and subtyping pandemic influenza A/H1N1 2009, seasonal influenza A/H1N1, and seasonal influenza A/H3N2 viruses. Journal of Virological Methods 2011, 171:156-162.
25. Osterholm M.T., Kelley N.S., Sommer A., Belongia E.A. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infectious Diseases 2012, 12:36-44.
26. Reed L.J., Muench H. A simple method for estimating fifty percent endpoints. American Journal of Hygiene 1938, 27:5.
27. Rodrigues R., Telles J.N., Essere K., Ducournau C., Roqueplo C., Levieuge A., Davoust B., Parola P., Paranhos-Baccala G., Peyrefitte C.N. Development of a one step real time RT-PCR assay to detect and quantify Dugbe virus. Journal of Virological Methods 2011, 176:74-77.
28. Rudenko L., van den Bosch H., Kiseleva I., Mironov A., Naikhin A., Larionova N., Bushmenkov D. Live attenuated pandemic influenza vaccine: clinical studies on A/17/California/2009/38 (H1N1) and licensing of the Russian-developed technology to WHO for pandemic influenza preparedness in developing countries. Vaccine 2011, 29(Suppl. 1):A40-A44.
29. Rudenko L.G., Lonskaya N.I., Klimov A.I., Vasilieva R.I., Ramirez A. Clinical and epidemiological evaluation of a live, cold-adapted influenza vaccine for 3-14-year-olds. Bulletin of the World Health Organization 1996, 74:77-84.
30. Sakamoto S., Kino Y., Oka T., Herlocher M.L., Maassab F. Gene analysis of reassortant influenza virus by RT-PCR followed by restriction enzyme digestion. Journal of Virological Methods 1996, 56:161-171.
31. Shu B., Wu K.H., Emery S., Villanueva J., Johnson R., Guthrie E., Berman L., Warnes C., Barnes N., Klimov A., Lindstrom S. Design and performance of the CDC real-time reverse transcriptase PCR swine flu panel for detection of 2009 A (H1N1) pandemic influenza virus. Journal of Clinical Microbiology 2011, 49:2614-2619.
32. Spackman E., Senne D.A., Myers T.J., Bulaga L.L., Garber L.P., Perdue M.L., Lohman K., Daum L.T., Suarez D.L. Development of a real-time reverse transcriptase PCR assay for type A influenza virus and the avian H5 and H7 hemagglutinin subtypes. Journal of Clinical Microbiology 2002, 40:3256-3260.
33. Thompson W.W., Shay D.K., Weintraub E., Brammer L., Cox N., Anderson L.J., Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA: Journal of the American Medical Association 2003, 289:179-186.
34. Tyrrell D.A., Valentine R.C. The assay of influenza virus particles by haemagglutination and electron microscopy. Journal of General Microbiology 1957, 16:668-675.
35. Wareing M.D., Marsh G.A., Tannock G.A. Preparation and characterisation of attenuated cold-adapted influenza A reassortants derived from the A/Leningrad/134/17/57 donor strain. Vaccine 2002, 20:2082-2090.
36. WHO WHO Recommendations to Assure the Quality, Safety, and Efficacy of Influenza Vaccines (Human, Live Attenuated) for Intranasal Administration 2009, WHO, Geneva.
37. Wise M.G., Suarez D.L., Seal B.S., Pedersen J.C., Senne D.A., King D.J., Kapczynski D.R., Spackman E. Development of a real-time reverse-transcription PCR for detection of newcastle disease virus RNA in clinical samples. Journal of Clinical Microbiology 2004, 42:329-338.
38. Yeolekar L.R., Dhere R.M. Development and validation of an egg-based potency assay for a trivalent live attenuated influenza vaccine. Biologicals: Journal of the International Association of Biological Standardization 2012, 40:146-150.
39. Zhao C., Li Z., Yan B., Harrison T.J., Guo X., Zhang F., Yin J., Yan Y., Wang Y. Comparison of real-time fluorescent RT-PCR and conventional RT-PCR for the detection of hepatitis E virus genotypes prevalent in China. Journal of Medical Virology 2007, 79:1966-1973.