Preflucel®: A Vero-cell culture-derived trivalent influenza vaccine

Expert Review of Vaccines

Volumn 11, Issue 7, 2012, Pages 759-773

  Yuen, Candice ^a   Chan, Yue ^a   Tambyah, Paul Anantharajah ^a  

^a Genome Institute of Singapore   (Singapore)

Author keywords

cell culture; H1N1; H3N2; H5N1; influenza; preflucel; prevention of influenza; trivalent; vaccine

Indexed keywords

AMANTADINE; AVIAN INFLUENZA VACCINE; INFLUENZA VACCINE; OSELTAMIVIR; PLACEBO; ZANAMIVIR;

2009 H1N1 INFLUENZA; ANOREXIA; ANTIGEN STRUCTURE; ANTIGENIC VARIATION; ANTIGENICITY; AVIAN INFLUENZA VIRUS; BACTERIAL INFECTION; CELL CULTURE; CELL STRAIN; CHICKEN; CHILL; CHRONIC LUNG DISEASE; COUGHING; CROUP; DRUG EFFICACY; DRUG FORMULATION; DRUG TOLERANCE; EUROPEAN UNION; FATIGUE; FEVER; HEADACHE; HUMAN; HYPERHIDROSIS; HYPERTENSIVE CRISIS; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOGENICITY; INCIDENCE; INFLUENZA; INFLUENZA A; INFLUENZA B; INFLUENZA VIRUS A; INFLUENZA VIRUS B; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; LABORATORY DIAGNOSIS; LICENCE; LIFE CYCLE; MALAISE; MAMMAL CELL; MYALGIA; NONHUMAN; OROPHARYNX PAIN; PANDEMIC INFLUENZA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; SEASONAL INFLUENZA; SECONDARY INFECTION; SIMIAN VIRUS 40; UNITED STATES; VACCINATION; VERO CELL; VIRAL RESPIRATORY TRACT INFECTION; VIRUS PNEUMONIA;

ANIMALS; ANTIGENS, VIRAL; CERCOPITHECUS AETHIOPS; HUMANS; INFLUENZA A VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; TREATMENT OUTCOME; VACCINATION; VACCINES, SYNTHETIC; VERO CELLS;

EID: 84865414271     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/erv.12.55     Document Type: Review

References (53)

1. Stephenson I, Nicholson KG, Wood JM, Zambon MC, Katz JM. Confronting the avian influenza threat: Vaccine development for a potential pandemic. Lancet Infect. Dis. 4(8), 499-509 (2004). (Pubitemid 39077920)
2. Treanor JJ. Influenza viruses, including avian influenza and swine influenza. In: Manell, Douglas, and Bennett's Principles and Practice of Infectious Diseases (7th Edition). Mandell GL, Bennett JE, Dolin R (Eds). Churchill Livingstone, PA, USA, 2265-2288 (2009).
3. Wang S, Le TQ, Kurihara N et al. Influenza virus-cytokine-protease cycle in the pathogenesis of vascular hyperpermeability in severe influenza. J. Infect. Dis. 202(7), 991-1001 (2010).
4. Zimmer SM, Burke DS. Historical perspective-emergence of influenza A (H1N1) viruses. N. Engl. J. Med. 361(3), 279-285 (2009).
5. Ferguson NM, Cummings DA, Fraser C, Cajka JC, Cooley PC, Burke DS. Strategies for mitigating an influenza pandemic. Nature 442(7101), 448-452 (2006). (Pubitemid 44264793)
6. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb. Mortal. Wkly Rep. 60, 1128-1132 (2011).
7. Wood JM, Williams MS. History of inactivated vaccines. In: Textbook of Influenza. Nicholson KG, Webster RG, Hay AJ (Eds). Blackwell Science, Oxford, UK, 317-323 (1998).
8. Kistner O, Barrett PN, Mundt W, Reiter M, Schober-Bendixen S, Dorner F. Development of a mammalian cell (Vero) derived candidate influenza virus vaccine. Vaccine 16(9-10), 960-968 (1998). Early development of a Vero-cell system for influenza vaccine production on an industrial scale. (Pubitemid 28276008)
9. Ehrlich HJ, Müller M, Fritsch S et al. A cell culture (Vero)-derived H5N1 whole-virus vaccine induces cross-reactive memory responses. J. Infect. Dis. 200(7), 1113-1118 (2009). Study to determine the effectiveness of a booster vaccination for H5N1 influenza using Vero-cell culture vaccine.
10. Ehrlich HJ, Müller M, Oh HM et al.; Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N. Engl. J. Med. 358(24), 2573-2584 (2008). Initial Phase I and II randomized controlled trial to study Vero-cell culture-derived H5N1 vaccine in healthy adults aged 18-45 years. (Pubitemid 351831358)
11. Pandey A, Singh N, Sambhara S, Mittal SK. Egg-independent vaccine strategies for highly pathogenic H5N1 influenza viruses. Hum. Vaccin. 6(2), 178-188 (2010).
12. Audsley JM, Tannock GA. Cell-based influenza vaccines: Progress to date. Drugs 68(11), 1483-1491 (2008). (Pubitemid 352001186)
13. Engels EA. Cancer risk associated with receipt of vaccines contaminated with simian virus 40: Epidemiologic research. Expert Rev. Vaccines 4(2), 197-206 (2005). (Pubitemid 40525061)
14. Engels EA, Viscidi RP, Galloway DA et al. Case-control study of simian virus 40 and non-Hodgkin lymphoma in the United States. J. Natl Cancer Inst. 96(18), 1368-1374 (2004). (Pubitemid 39406170)
15. Strickler HD, Rosenberg PS, Devesa SS, Hertel J, Fraumeni JF Jr, Goedert JJ. Contamination of poliovirus vaccines with simian virus 40 (1955-1963) and subsequent cancer rates. JAMA 279(4), 292-295 (1998). (Pubitemid 28071020)
16. Poulin DL, DeCaprio JA. Is there a role for SV40 in human cancer? J. Clin. Oncol. 24(26), 4356-4365 (2006). (Pubitemid 46630795)
17. Glezan WP. Cell-culture-derived influenza vaccine production. Lancet 377 (9767), 698-700 (2011).
18. Pandey A, Singh N, Mittal SK. Eggindependent vaccine strategies for highly pathogenic H5N1 influenza viruses. Hum. Vaccin. doi:10.4161/hv.6.2.9899 (2010) (Epub ahead of print).
19. Katz JM, Webster RG. Efficacy of inactivated influenza A virus (H3N2) vaccines grown in mammalian cells or embryonated eggs. J. Infect. Dis. 160(2), 191-198 (1989). Early study in ferrets suggests that the human influenza viruses grown in mammalian cells may be antigenically similar to human influenza viruses and more efficacious as vaccines than variants selected in eggs. (Pubitemid 19189009)
20. Palache AM, Scheepers HS, de Regt V et al. Safety, reactogenicity and immunogenicity of Madin Darby canine kidney cell-derived inactivated influenza subunit vaccine. A meta-analysis of clinical studies. Dev. Biol. Stand. 98, 115-125; discussion 133 (1999).
21. Percheson PB, Trépanier P, Dugré R, Mabrouk T. A Phase I, randomized controlled clinical trial to study the reactogenicity and immunogenicity of a new split influenza vaccine derived from a non-tumorigenic cell line. Dev. Biol. Stand. 98, 127-132; discussion 133 (1999). Early randomized controlled trial of Madin-Darby canine kidney cell (MDCK) culture-derived influenza vaccine showed that the vaccine is safe and immunogenic in healthy adults.
22. Palache AM, Brands R, van Scharrenburg GJ. Immunogenicity and reactogenicity of influenza subunit vaccines produced in MDCK cells or fertilized chicken eggs. J. Infect. Dis. 176(Suppl. 1), S20-S23 (1997). Prospective, randomized, double-blind study that compared MDCK-or eggderived influenza subunit vaccines in healthy volunteers. Both vaccines are well tolerated and meet European Committee for Medicinal Products for Human Use (EU CHMP) requirements for influenza vaccines. (Pubitemid 27315341)
23. Halperin SA, Nestruck AC, Eastwood BJ. Safety and immunogenicity of a new influenza vaccine grown in mammalian cell culture. Vaccine 16(13), 1331-1335 (1998). Phase I randomized controlled study in 112 healthy adults to determine the safety and immunogenicity of a split virion influenza vaccine derived from MDCK cells compared with egg-derived vaccine. Cell culture vaccine was shown to be safe and immunogenic. (Pubitemid 28308415)
24. Groth N, Montomoli E, Gentile C, Manini I, Bugarini R, Podda A. Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: A sequential Phase I and Phase II clinical trial. Vaccine 27(5), 786-791 (2009). Phase I and II randomized controlled trial in 240 adults to determine the safety and immunogenicity of MDCK cellderived vaccine compared with trivalent influenza vaccine. Safety, tolerability were equivalent. Both vaccines met all EU CHMP criteria.
25. Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine 27(43), 6022-6029 (2009). Phase I and II randomized controlled study in 240 healthy adults showed equivalent safety and tolerability profiles between MDCK cell-derived vaccine and control vaccines.
26. 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. 200(6), 841-848 (2009). Phase III study in 2654 healthy adults to determine safety and immunogenicity of MDCK cell-culture vaccine versus egg-produced vaccine showed that both vaccines were well tolerated and could achieve EU CHMP criteria for licensure.
27. Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: Comparison of safety, reactogenicity, and immunogenicity. J. Infect. Dis. 200(6), 849-857 (2009). Randomized controlled study of MDCK cell-culture vaccine versus egg-produced vaccine showed that both vaccines were comparable in terms of immunogenicity and safety.
28. 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. 27(7), 444-457 (2010).
29. Keitel W, Groth N, Lattanzi M et al. Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: Safety and immunogenicity of a Phase 1/2 clinical trial. Vaccine 28(3), 840-848 (2010). Study showed that immunogenicity of MDCK cell-culture H5N1 vaccine could be enhanced by addition of an adjuvant.
30. 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. 51(9), 997-1004 (2010). Largest randomized trial of 11,404 healthy adults, compared MDCK cell-derived vaccine versus egg-culture vaccine and placebo. Results show that MDCK vaccine was superior to trivalent influenza vaccine for protective efficacy.
31. Kistner O, Howard MK, Spruth M et al. Cell culture (Vero) derived whole virus (H5N1) vaccine based on wild-type virus strain induces cross-protective immune responses. Vaccine 25(32), 6028-6036 (2007). (Pubitemid 47077543)
32. Waddington CS, Walker WT, Oeser C et al. Safety and immunogenicity of AS03B adjuvanted split virion versus nonadjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: Open label, randomised, parallel group, multicentre study. BMJ 340, c2649 (2010). Randomized controlled Phase II clinical study in 943 healthy children compared unadjuvanted Vero-cell-derived vaccine with adjuvanted egg vaccine. Adjuvanted egg vaccine was more immunogenic and reactogenic.
33. Barrett PN, Berezuk G, Fritsch S et al. Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: A multicentre, double-blind, randomised, placebo-controlled trial. Lancet 377(9767), 751-759 (2011). Largest randomized controlled Phase III study on Vero-cell-culture vaccine compared with placebo. Vero-cell trivalent vaccine was protective against influenza infection and well tolerated. Immunogenicity, seroprotecion and seroconversion rates of all three vaccine strains fulfilled requirements of the Committee for Proprietary Medicinal Products and the US FDA.
34. Nicholson KG, Abrams KR, Batham S et al. Immunogenicity and safety of a two-dose schedule of whole-virion and AS03A-adjuvanted 2009 influenza A (H1N1) vaccines: A randomised, multicentre, age-stratified, head-to-head trial. Lancet Infect. Dis. 11(2), 91-101 (2011).
35. Keitel WA, Dekker CL, Mink C et al. Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults. Vaccine 27(47), 6642-6648 (2009).
36. Howard MK, Kistner O, Barrett PN. Pre-clinical development of cell culture (Vero)-derived H5N1 pandemic vaccines. Biol. Chem. 389(5), 569-577 (2008). Preclinical study shows that the vaccine induces cross-neutralizing antibody not only against the homologous virus but also against other H5N1 strains (including those from other clades). Suggests cell culture-type virus allows rapid-yield production of a candidate pandemic vaccine. (Pubitemid 351874194)
37. Belongia EA, Kieke BA, Donahue JG et al.; Marshfield Influenza Study Group. Effectiveness of inactivated influenza vaccines varied substantially with antigenic match from the 2004-2005 season to the 2006-2007 season. J. Infect. Dis. 199(2), 159-167 (2009).
38. Beran J, Wertzova V, Honegr K et al. Challenge of conducting a placebocontrolled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: A concrete example. BMC Infect. Dis. 9, 2 (2009).
39. Ohmit SE, Victor JC, Rotthoff JR et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N. Engl. J. Med. 355(24), 2513-2522 (2006). (Pubitemid 44917499)
40. Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst. Rev. 7, CD001269 (2010). A meta-analysis of 50 randomized controlled trials or quasi-randomized controlled trials from 1966 to 2010 of over 70,000 people comparing influenza vaccines with placebo or no intervention in naturally occurring influenza in healthy adults aged 16-65 years. The author concludes that influenza vaccines have a modest effect in reducing influenza symptoms and working days lost.
41. Lagler H, Wenisch JM, Tobudic S et al. Pandemic influenza A H1N1 vaccine in recipients of solid organ transplants: Immunogenicity and tolerability outcomes after vero cell derived, non-adjuvanted, whole-virion vaccination. Vaccine 29(40), 6888-6893 (2011).
42. Gregerson JP. A risk assessment model to rate the occurrence and relevance of adventitious agents in the production of influenza vaccines. Vaccine 26(26), 3297-3304 (2008).
43. Cox RJ, Madhun AS, Hauge S et al. A Phase I clinical trial of a PER.C6 cell grown influenza H7 virus vaccine. Vaccine 27(13), 1889-1897 (2009).
44. Centres for Disease Control and Prevention (CDC). Update: Influenza activity-United states and worldwide, 2003-04 season, and composition of the 2004-5 influenza vaccine. MMWR Morb. Mortal. Wkly Rep. 53(25), 547-552 (2004).
45. Centres for Disease Control and Prevention (CDC). Update: Influenza activity-United states, 2010-11 season, and composition of the 2011-12 influenza vaccine. MMWR Morb. Mortal. Wkly Rep. 60(21), 705-712 (2011).
46. Minor PD, Engelhardt OG, Wood JM et al. Current challenges in implementing cell-derived influenza vaccines: Implications for production and regulation, July 2007, NIBSC, Potters Bar, UK. Vaccine 27(22), 2907-2913 (2009).
47. George M, Farooq M, Dang T, Cortes B, Liu J, Maranga L. Production of cell culture (MDCK) derived live attenuated influenza vaccine (LAIV) in a fully disposable platform process. Biotechnol. Bioeng. 106(6), 906-917 (2010).
48. Stech J, Garn H, Herwig A et al. Influenza B virus with modified hemagglutinin cleavage site as a novel attenuated live vaccine. J. Infect. Dis. 204(10), 1483-1490 (2011).
49. Masic A, Babiuk LA, Zhou Y. Reverse genetics-generated elastase-dependent swine influenza viruses are attenuated in pigs. J. Gen. Virol. 90(Pt 2), 375-385 (2009).
50. Gabriel G, Garn H, Wegmann M et al. The potential of a protease activation mutant of a highly pathogenic avian influenza virus for a pandemic live vaccine. Vaccine 26(7), 956-965 (2008).
51. Wressnigg N, Voss D, Wolff T et al. Development of a live-attenuated influenza B DeltaNS1 intranasal vaccine candidate. Vaccine 27(21), 2851-2857 (2009).
52. Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database Syst. Rev. 2, CD004879 (2008). A meta analysis of 51 studies with 294,159 people. Influenza vaccines are efficacious in children older than 2 years of age, but little evidence is available for children under 3 years of age. No safety comparisons could be carried out. Limited evidence is available in children under 3 years of age.
53. Jefferson T, Di Pietrantonj C, Al-Ansary LA, Ferroni E, Thorning S, Thomas RE. Vaccines for preventing influenza in the elderly. Cochrane Database Syst. Rev. 2, CD004876 (2010).