A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine

Vaccine

Volumn 27, Issue 43, 2009, Pages 6022-6029

  Ambrozaitis, Arvydas ^a   Groth, Nicola ^b   Bugarini, Roberto ^b   Sparacio, Vittoria ^b   Podda, Audino ^b   Lattanzi, Maria ^b  

^a VILNIUS UNIVERSITY   (Lithuania)

^b NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

Cell culture; Influenza; Lot to lot consistency

Indexed keywords

ANALGESIC AGENT; ANTIPYRETIC AGENT; HEMAGGLUTINATION INHIBITING ANTIBODY; INFLUENZA VACCINE; VIRUS ANTIGEN;

ADULT; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BLOOD SALVAGE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECCHYMOSIS; ERYTHEMA; FATIGUE; FEMALE; HUMAN; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H3N2; INFLUENZA VIRUS B; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALAISE; MALE; MAMMAL CELL; MULTICENTER STUDY; MYALGIA; PHASE 3 CLINICAL TRIAL; PHYSICIAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SIDE EFFECT; SKIN INDURATION; SWEATING;

ADULT; ANTIBODIES, VIRAL; CELL CULTURE TECHNIQUES; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; QUALITY CONTROL; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 70349265936     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.07.083     Document Type: Article

References (20)

1. WHO Consultation on the composition of influenza vaccine for the Southern Hemisphere 2007. Geneva: WHO. Available from http://www.who.int/csr/disease/influenza/vaccinerecommendations1/en/; 2006 [accessed March 09, 2009].
2. Ulmer J.B., Valley U., and Rappuoli R. Vaccine manufacturing: challenges and solutions. Nat Biotechnol 24 11 (2006) 1377-1383
3. Govorkova E.A., Kodihalli S., Alymova I.V., Fanget B., and Webster R.G. Growth and immunogenicity of influenza viruses cultivated in Vero or MDCK cells and in embryonated chicken eggs. Dev Biol Stand 98 (1999) 39-51
4. Kessler N., Thomas-Roche G., Gerentes L., and Aymard M. Suitability of MDCK cells grown in a serum-free medium for influenza virus production. Dev Biol Stand 98 (1999) 13-21
5. Mabrouk T., and Ellis R.W. Influenza vaccine technologies and the use of the cell-culture process (cell-culture influenza vaccine). Dev Biol (Basel) 110 (2002) 125-134
6. Audsley J.M., and Tannock G.A. Cell-based influenza vaccines: progress to date. Drugs 68 11 (2008) 1483-1491
7. Brands R., Visser J., Medema J., Palache A.M., and van Scharrenburg G.J. Influvac: a safe Madin Darby Canine Kidney (MDCK) cell culture-based influenza vaccine. Dev Biol Stand 98 (1999) 93-100
8. Robertson J.S., Cook P., Attwell A.M., and Williams S.P. Replicative advantage in tissue culture of egg-adapted influenza virus over tissue-culture derived virus: implications for vaccine manufacture. Vaccine 13 16 (1995) 1583-1588
9. US Department of Health and Human Services. Vaccine production in cells. Available from http://www.pandemicflu.gov/vaccine/vproductioncells.html; 2006 [accessed March 09, 2009].
10. Palache A.M., Scheepers H.S., de Regt V., van Ewijk P., Baljet M., Brands R., 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 (1999) 115-125
11. Groth N., Montomoli E., Gentile C., Manini I., Bugarini R., and 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 (2009) 786-791
12. Szymczakiewicz-Multanowska A., Groth N., Bugarini R., Lattanzi M., Casula D., Hilbert A., et al. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis 200 6 (2009)
13. Reisinger K.S., Block S.L., Izu A., Groth N., and Holmes S.J. Subunit influenza vaccines produced from cell culture or in embryonated chicken-eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis 200 6 (2009)
14. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines. CPMP/BWP/214/96. Available from http://www.emea.europa.eu/pdfs/human/bwp/021496en.pdf; 12 March, 1997 [accessed February 25, 2009].
15. Bridges C.B., Katz J.M., Levandowski R.A., and Cox N.J. Inactivated influenza vaccines. In: Plotkin S.A., Orenstein W.A., and Offit P.A. (Eds). Vaccines. 5th edn. (2008), Saunders, Philadelphia 258-290
16. European Influenza Surveillance Scheme (EISS). Annual report 2005-2006 influenza season. March 2007. Available from http://www.eiss.org/documents/eiss_annual_report_2005-2006.pdf [accessed March 9, 2009].
17. Nauta J. Statistical analysis of influenza vaccine lot consistency studies. J Biopharm Stat 16 4 (2006) 443-452
18. Halperin S.A., Smith B., Mabrouk T., Germain M., Trépanier P., Hassell T., et al. Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children. Vaccine 20 7-8 (2002) 1240-1247
19. Zangwill K.M., Droge J., Mendelman P., Marcy S.M., Partridge S., Chiu C.Y., et al. Prospective, randomised, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children. Pediatr Infect Dis J 20 8 (2001) 740-746
20. Nolan T., Lee M.S., Cordova J.M., Cho I., Walker R.E., August M.J., et al. Safety and immunogenicity of a live-attenuated influenza vaccine blended and filled at two manufacturing facilities. Vaccine 21 11-12 (2003) 1224-1231