Flucelvax (Optaflu) for seasonal influenza

Expert Review of Vaccines

Volumn 14, Issue 6, 2015, Pages 789-804

  Manini, Ilaria ^a   Domnich, Alexander ^b   Amicizia, Daniela ^b   Rossi, Stefania ^a   Pozzi, Teresa ^a   Gasparini, Roberto ^b   Panatto, Donatella ^b   Montomoli, Emanuele ^a,c  

^a UNIVERSITY OF SIENA   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c VisMederi Srl   (Italy)

Author keywords

Flucelvax; influenza vaccine; MDCK cell culture; Optaflu; vaccination

Indexed keywords

INFLUENZA VACCINE; PLACEBO; PNEUMOCOCCUS VACCINE;

CARCINOGENICITY; CELL CULTURE; CLINICAL STUDY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HEADACHE; HUMAN; IMMUNOGENICITY; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H3N2; INJECTION SITE PAIN; NONHUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; SEASONAL INFLUENZA; VIRUS MUTATION; ANIMAL; CLINICAL TRIAL (TOPIC); DOG; DRUG SCREENING; IMMUNOLOGY; INFLUENZA, HUMAN; ISOLATION AND PURIFICATION; MDCK CELL LINE; PHARMACEUTICS; PROCEDURES; VACCINATION;

ANIMALS; CLINICAL TRIALS AS TOPIC; DOGS; DRUG EVALUATION, PRECLINICAL; HUMANS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MADIN DARBY CANINE KIDNEY CELLS; PRODUCT SURVEILLANCE, POSTMARKETING; TECHNOLOGY, PHARMACEUTICAL; VACCINATION;

EID: 84929297885     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.2015.1039520     Document Type: Review

References (71)

1. Fauci AS. Seasonal and pandemic influenza preparedness: science and countermeasures. J Infect Dis 2006;194(Suppl 2):S73-6.
2. Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine 2007; 25(27):5086-96.
3. Lai PL, Panatto D, Ansaldi F, et al. Burden of the 1999-2008 seasonal influenza epidemics in Italy: comparison withthe H1N1v (A/California/07/09) pandemic. Hum Vaccin 2011;7(Suppl):217-25.
4. World Health Organization (WHO). Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec 2012;87(47):461-76.
5. Mereckiene J, Cotter S, Nicoll A, et al. Seasonal influenza immunisation in Europe. Overview of recommendations and vaccination coverage for three seasons: pre-pandemic (2008/09), pandemic (2009/ 10) and post-pandemic (2010/11). Euro Surveill 2014;19(16):20780.
6. CDCs Advisory Committee on Immunization Practices (ACIP) recommends universal annual influenza vaccination. Press release. Available from: www.cdc.gov/media/pressrel/2010/r100224. htm
7. European Centre for Disease Prevention and Control (ECDC). Guidance Priority risk groups for influenza vaccination. ECDC; Stockholm: 2008.
8. Council recommendation of 22 December 2009 on seasonal influenza vaccination. Available from: http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ: L:2009:348:0071:0072:EN:PDF
9. European Centre for Disease Prevention and Control (ECDC). Influenza vaccination. Available from: www.ecdc.europa.eu/en/ healthtopics/seasonal-influenza/vaccines/ Pages/influenza-vaccination.aspx
10. Centers for Disease Control and Prevention (CDC). Influenza vaccines - United States, 2014-15 influenza season. Available from: www.cdc.gov/flu/pdf/protect/vaccine/ influenza-vaccines-table-2014-15.pdf
11. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother 2012;8(1):81-8.
12. Gasparini R, Amicizia D, Lai PL, Panatto D. Live attenuated influenza vaccine - a review. J Prev Med Hyg 2011;52(3): 95-101.
13. Fiore AE, Bridges CB, Cox NJ. Seasonal influenza vaccines. Curr Top Microbiol Immunol 2009;333:43-82.
14. Sheridan C. Production technologies change flu vaccine landscape. Nat Biotechnol 2007; 25(7):701.
15. World Health Organization (WHO). Global action plan for influenza vaccines: Global progress report: January 2006 - September 2013. WHO; Geneva: 2014.
16. Groth N, Montomoli E, Gentile C, et al. Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial. Vaccine 2009;27(5):786-91.
17. Wong SS, Webby RJ. Traditional and new influenza vaccines. Clin Microbiol Rev 2013;26(3):476-92.
18. European Medicines Agency (EMA). Optaflu. Authorization details. Available from: www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/ 000758/human-med-000952. jsp&mid=WC0b01ac058001d124.
19. Food and Drug Administration (FDA). Approval letter - Flucelvax. Available from: www.fda.gov/biologicsbloodvaccines/ vaccines/approvedproducts/ucm328684.htm
20. Noh JY, Kim WJ. Influenza vaccines: unmet needs and recent developments. Infect Chemother 2013;45(4):375-86.
21. Kresse H, Rovini H. Influenza vaccine market dynamics. Nat Rev Drug Discov 2009;8(11):841-2.
22. Frey S, Vesikari T, Szymczakiewicz-Multanowska A, et al. Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis 2010;51(9):997-1004.
23. Alexander DJ. An overview of the epidemiology of avian influenza. Vaccine 2007;25(30):5637-44.
24. Montomoli E, Khadang B, Piccirella S, et al. Cell culture-derived influenza vaccines from Vero cells: a new horizon for vaccine production. Expert Rev Vaccines 2012; 11(5):587-94.
25. Gregersen JP. A risk-assessment model to rate the occurrence and relevance of adventitious agents in the production of influenza vaccines. Vaccine 2008;26(26): 3297-304.
26. Donis RO; Influenza Cell Culture Working Group; Influenza Cell Culture Working Group. Performance characteristics of qualified cell lines for isolation and propagation of influenza viruses for vaccine manufacturing. Vaccine 2014;32(48): 6583-90.
27. Ampofo WK, Bachtiar NS, Bakamutumaho B, et al. Improving influenza vaccine virus selection: report of a WHO informal consultation held at WHO headquarters, Geneva, Switzerland, 14-16 June 2010. Influenza Other Respir Viruses 2012;6(2):142-52.
28. Neuzil KM, Bright RA. Influenza vaccine manufacture: keeping up with change. J Infect Dis 2009;200(6):835-7.
29. Zeiger RS. Current issues with influenza vaccination in egg allergy. J Allergy Clin Immunol 2002;110(6):834-40.
30. Nwaru BI, Hickstein L, Panesar SS, et al. Prevalence of common food allergies in Europe: a systematic review and meta-analysis. Allergy 2014;69(8):992-1007.
31. Onions D, Egan W, Jarrett R, et al. Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine. Biologicals 2010;38(5): 544-51.
32. Medema JK, Wijnands DT, Palache AM. The role of MDCK-based influenza vaccine Influvac TC in (inter) pandemics. Int Congr Ser 2004;1263:822-5.
33. Dormitzer PR. Cell culture-derived influenza vaccines. In: Del Giudice G, Rappuoli R, editors. Influenza vaccines for the future, 2nd edition. Springer Basel AG, 2011.
34. Yasuda Y, Komatsu R, Matsushita K, et al. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Adv Ther 2010;27(7):444-57.
35. Clark TW, Pareek M, Hoschler K, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009;361(25):2424-35.
36. Reynales H, Astudillo P, de Vallière S, et al. A prospective observational safety study on MF59(-) adjuvanted cell culture-derived vaccine, Celtura(-) during the A/H1N1. (2009) influenza pandemic. Vaccine 2012; 30(45):6436-43.
37. Chan CY, Tambyah PA. Preflucel-: a Vero-cell culture-derived trivalent influenza vaccine. Expert Rev Vaccines 2012;11(7):759-73.
38. European Medicines Agency (EMA). Questions and answers on the review of Preflucel and associated names (influenza vaccine, purified antigen). Available from: www.ema.europa.eu/docs/en-GB/ document-library/Referrals-document/ Preflucel/WC500130157.pdf
39. Yang LP. Recombinant trivalent influenza vaccine (flublok(-)): a review of its use in the prevention of seasonal influenza in adults. Drugs 2013;73(12):1357-66.
40. Traynor K. First recombinant flu vaccine approved. Am J Health Syst Pharm 2013; 70(5):382.
41. Doroshenko A, Halperin SA. Trivalent MDCK cell culture-derived influenza vaccine Optaflu (Novartis Vaccines). Expert Rev Vaccines 2009;8(6):679-88.
42. Food and Drug Administration (FDA). Flucelvax clinical review. Available from: www.fda.gov/downloads/ BiologicsBloodVaccines/Vaccines/ ApprovedProducts/UCM332069.pdf
43. Suphaphiphat P, Keiner B, Trusheim H, et al. Human RNA polymerase I-driven reverse genetics for influenza a virus in canine cells. J Virol 2010;84(7):3721-5.
44. Peck H, Dodin J, Baas C, et al. Evaluation of growth, genetic, and antigenic characteristics of pandemic H1N1 viruses isolated and passaged in qualified MDCK suspension cells (MDCK33016PF) and embryonated hen eggs. Influenza Other Respir Viruses 2011;5(Suppl 1):366-9.
45. Roth B, Mohr H, Enders M, et al. Isolation of influenza viruses in MDCK 33016PF cells and clearance of contaminating respiratory viruses. Vaccine 2012;30(3): 517-22.
46. Polovic N, Waden K, Binnmyr J, et al. Dog saliva - an important source of dog allergens. Allergy 2013;68(5):585-92.
47. Wanich N, Bencharitiwong R, Tsai T, Nowak-Wegrzyn A. In vitro assessment of the allergenicity of a novel influenza vaccine produced in dog kidney cells in individuals with dog allergy. Ann Allergy Asthma Immunol 2010;104(5):426-33.
48. Bencharitiwong R, Leonard S, Tsai T, Nowak-We?grzyn A. In vitro assessment of the allergenicity of novel MF59-adjuvanted pandemic H1N1 influenza vaccine produced in dog kidney cells. Hum Vaccin Immunother 2012;8(7):863-5.
49. Note for guidance on harmonisation of requirements for influenza vaccines. Available from: www.ema.europa.eu/docs/ en-GB/document-library/ Scientific-guideline/2009/09/ WC500003945.pdf
50. Food and Drug Administration (FDA). Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines. Available from: www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/Vaccines/ ucm074794.htm
51. Reisinger KS, Block SL, Izu A, et al. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis 2009;200(6): 849-57.
52. Vesikari T, Block SL, Guerra F, et al. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J 2012;31(5):494-500.
53. Ambrozaitis A, Groth N, Bugarini R, et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine 2009;27(43): 6022-9.
54. Szymczakiewicz-Multanowska A, Groth N, Bugarini R, et al. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis 2009;200(6):841-8.
55. Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, et al. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother 2012; 8(5):645-52.
56. Vinnemeier CD, Fischer-Herr J, Meyer S, et al. Immunogenicity and safety of an inactivated 2012/2013 trivalent influenza vaccine produced in mammalian cell culture (Optaflu): an open label, uncontrolled study. Hum Vaccin Immunother 2014; 10(2):441-8.
57. Loebermann M, Voss U, Meyer S, et al. Clinical trial to evaluate the safety and immunogenicity of a trivalent surface antigen seasonal influenza vaccine produced in mammalian cell culture and administered to young and elderly adults with and without A(H1N1) pre-vaccination. PLoS One 2013;8(8):e70866.
58. Perez-Rubio A, Bouza JM. [An experience of the use of cell culture-derived influenza vaccines in an influenza vaccination campaign]. Gac Sanit 2014;28(1):88-9.
59. Belsey MJ, de Lima B, Pavlou AK, Savopoulos JW. Influenza vaccines. Nat Rev Drug Discov 2006;5(3):183-4.
60. Willyard C. Cell-based vaccines yield only modest advances for seasonal flu. Nat Med 2013;19(1):4.
61. Flucelvax pregnancy registry: an observational study on the safety of Flucelvax exposure in pregnant women and their offspring. Available from: www. clinicaltrials.gov/ct2/show/NCT02258178.
62. Safety, tolerability, and immunogenicity of GC3106 (quadrivalent cell-culture based influenza vaccine). Available from: www. clinicaltrials.gov/ct2/show/NCT02249221.
63. Study of the safety and immunogenicity of an influenza vaccine administered to healthy adults. Available from: https://clinicaltrials. gov/ct2/show/NCT00264576.
64. Safety and immunogenicity of a cell culture-derived influenza vaccine in healthy adults and elderly. Available from: https:// clinicaltrials.gov/ct2/show/NCT00492063.
65. Comparison of safety, tolerability and immunogenicity of influenza vaccines in adults and elderly. Available from: https:// clinicaltrials.gov/ct2/show/NCT00306527.
66. Safety and immunogenicity of 3 lots of cell-derived subunit influenza vaccine as compared to 1 lot to egg-derived subunit influenza vaccine in healthy adults (18 to 60). Available from: https://clinicaltrials. gov/ct2/show/NCT00310804.
67. Second extension study to evaluate safety and tolerability of influenza vaccines in adults and elderly, and to evaluate immunogenicity and concomitant vaccination with pneumococcal vaccine in a subgroup. Available from: https:// clinicaltrials.gov/ct2/show/NCT00579345.
68. Pediatric safety and immunogenicity study of cell-culture derived and egg-based subunit influenza vaccines in healthy children and adolescents. Available from: https:// clinicaltrials.gov/ct2/show/NCT00645411.
69. Efficacy study of two influenza vaccines and placebo in healthy adult subjects. Available from: https://clinicaltrials.gov/ct2/show/ NCT00630331.
70. Safety and immunogenicity of one dose of a surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture administered to adult and elderly subjects. Available from: https://clinicaltrials.gov/ct2/ show/NCT01422512.
71. Safety and immunogenicity of a cell derived subunit trivalent nonadjuvated influenza study vaccine in adults aged 18 years and above. Available from: https://clinicaltrials. gov/ct2/show/NCT01640314.