ORIGINAL RESEARCH

Evaluation of avian adenovirus inactivation methods used in the production of influenza vaccines

About authors

1 Saint Petersburg Research Institute of Vaccines and Serums, FMBA, Russia

2 Saint Petersburg Pasteur Research Institute of Epidemiology and Microbiology, Saint Petersburg, Russia

Correspondence should be addressed: Natalya N. Savina
Svobody, 52, Krasnoye Selo, Saint Petersburg, 198320; ur.sviinbps@anivas.n.n

About paper

Author contribution: all authors have equally contributed to the methodology of the study, analysis and interpretation of the results and manuscript preparation.

Compliance with ethical standards: the study complied with the principles of the Declaration of Helsinki (1964) and its revisions.

Received: 2021-08-18 Accepted: 2021-09-12 Published online: 2021-09-26
|
  1. Guideline on Influenza vaccines — Quality module. EMA/CHMP/BWP/310834/2012 Rev.1 Committee for Medicinal Products for Human use (CHMP), 2017. Available from: https://www.ema. europa.eu/en/documents/scientific-guideline/guideline-influenzavaccines-quality-module-revision-1_en.pdf.
  2. Serija tehnicheskih dokladov VOZ, # 927, 2005 god. Prilozhenie 3. Rekomendacii po proizvodstvu i kontrolju vakcin protiv grippa (inaktivirovannyh). Russian.
  3. Sabbaghi A, Miri SM, Keshavarz M, Zargar M, Ghaemi A. Inactivation methods for whole influenza vaccine production. Rev Med Virol. 2019 Nov; 29 (6): e2074.
  4. King AMQ, Adams MJ, Carstens EB, Leftkowitc EJ, editors. Virus Taxonomy: Classification and Nomenclature of Viruses. Ninth Report of the International Committee on Taxonomy of Viruses. Elsevier, 2012; 1327 p.
  5. Qing Pan, Jing Wang, Yulong Gao, Qi Wang, Hongyu Cui, Changjun Liu, et al. Identification of chicken CAR homology as a cellular receptor for the emerging highly pathogenic fowl adenovirus 4 via unique binding mechanism, Emerging Microbes & Infections. 2020; 9 (1): 586–96.
  6. Bakulin V. A., Muryj V. A. Adenovirusnyj gepatit s vkljuchenijamigidroperikardit kur: jepizootologija, diagnostika i specificheskaja profilaktika. Bio. 2011; 12: 28–30. Russian.
  7. Borisov VV. Razrabotka sredstv i metodov diagnostiki i specificheskoj profilaktiki adenovirusnyh boleznej kur [dissertacija]. Ivanovo, 2007.
  8. Kap M, Arron GI, Loibner M, Hausleitner A, Siaulyte G, Zatloukal K, Riegman P. Inactivation of Influenza A virus, Adenovirus, and Cytomegalovirus with PAXgene Tissue Fixative and Formalin. Biopreservation and Biobanking. 2013; 11 (4): 229–34.
  9. Herrera-Rodriguez J, Signorazzi A, Holtrop M, de Vries-Idema J, Huckriede A. Inactivated or damaged? Comparing the effect of inactivation methods on influenza virions to optimize vaccine production. Vaccine. 2019; 37 (12): 1630–7.
  10. Shuo Lei, Xun Gao, Yang Sun, Xiangyong Yu, Longshan Zhao. Gas chromatography-mass spectrometry method for determination of β-propiolactone in human inactivated rabies vaccine and its hydrolysis analysis, Journal of Pharmaceutical Analysis. 2018; 8 (6): 373–7.
  11. Rukovodstvo po issledovaniju validacii virusnoj ochistki: proektirovanie, vklad i interpretacija issledovanij, ispol'zujushhih inaktivaciju i udalenie virusov. EMA CPMP/BWP/268/95; 1996. Russian.
  12. Reed LJ, Muench H. A simple method of estimating fifty percent endpoints. The American Journal of Hygiene. 1938; 27: 493–7.
  13. Haussmann C, Hauschild F, Jobst B, Novartis AG, assignee. Improvements in preparation of influenza virus vaccine antigens. United States patent US № US6986808P. 18.03.2008.
  14. Burt DS, Jones DH, Lowell GH, White GL, Torossian K, Fries LF, assignee. ID Biomedical Corp of Quebec. Proteosome influenza vaccine. United States patent US № US18247600P. 15.02.2000.
  15. Truhin VP, Evtushenko AYe, Krasilnikov IV, Savina NN, Bykov DG, Ujba SV, Vasilev AN, Ryskova EV, Nacharova EP, Arakelov SA, avtory; Federal'noe gosudarstvennoe unitarnoe predprijatie «Sankt-Peterburgskij nauchno-issledovatel'skij institut vakcin i syvorotok i predprijatie po proizvodstvu bakterijnyh preparatov» Federal'nogo mediko-biologicheskogo agentstva (FGUP SPbNIIVS FMBA Rossii), patentoobladatel'. Sposob poluchenija antigena ili antigenov dlja proizvodstva protivogrippoznoj vakciny i vakcina na ego osnove. Patent RF # RU2019118695A. 14.06.2019. Russian.