Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: A sequential Phase I and Phase II clinical trial

Vaccine

Volumn 27, Issue 5, 2009, Pages 786-791

  Groth, N ^a   Montomoli, E ^b   Gentile, C ^b   Manini, I ^b   Bugarini, R ^a   Podda, A ^a  

^a NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^b UNIVERSITY OF SIENA   (Italy)

Author keywords

Cell culture; Influenza; Vaccine

Indexed keywords

CELL CULTURE DERIVED INFLUENZA VACCINE; INFLUENZA VACCINE; UNCLASSIFIED DRUG;

ADULT; AGED; ARTHRALGIA; ARTICLE; CELL STRAIN; CELL STRAIN MDCK 33016 PF; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; ECCHYMOSIS; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; MALAISE; MALE; MYALGIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SWEATING;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANIMALS; ANTIBODIES, VIRAL; CELL CULTURE TECHNIQUES; CELL LINE; DOGS; HUMANS; INFLUENZA VACCINES; MIDDLE AGED; YOUNG ADULT;

EID: 58149494369     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.11.003     Document Type: Article

References (31)

1. World Health Organization. Influenza vaccines. WHO position paper. Wkly Epidemiol Rec 2005;33:279-87.
2. Sprenger M.J., Mulder P.G., Beyer W.E., Van Strik R., and Masurel N. Impact of influenza on mortality in relation to age and underlying disease, 1967-1989. Int J Epidemiol 22 (1993) 334-340
3. Thompson W.W., Shay D.K., Weintraub E., Brammer L., Cox N., Anderson L.J., et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 289 (2003) 179-186
4. Szucs T.D. Influenza: the role of burden-of-illness research. Pharmacoeconomics 16 (1999) S27-32
5. Szucs T.D. Medical economics in the field of influenza-past, present and future. Virus Res 103 (2004) 25-30
6. Keech M., Scott A.J., and Ryan P.J. The impact of influenza and influenza-like illness on productivity and healthcare resource utilization in a working population. Occup Med (Lond) 48 (1998) 85-90
7. Treanor J. Influenza vaccine-outmaneuvering antigenic shift and drift. NEJM 350 (2004) 218-220
8. Zambon M.C. Epidemiology and pathogenesis of influenza. J Antimicrob Chemother 44 Suppl. B (1999) 3-9
9. Monto A. Epidemiology and virology of influenza illness. Am J Manage Care 6 (2000) S255-S264
10. Mabrouk T., and Ellis R.W. Influenza vaccine technologies and the use of cell-culture processes (cell-culture influenza vaccine). Dev Biol (Basel) 110 (2002) 125-134
11. Kistner O., Barrett P.N., Mundt W., Reiter M., Schober-Bendixen S., and Dorner F. Development of a mammalian cell (Vero) derived candidate influenza virus vaccine. Vaccine 16 (1998) 960-968
12. 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
13. 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 (2002) 1240-1247
14. Treanor J.J., Schiff G.M., Hayden F.G., Brady R.C., Hay C.M., Meyer A.L., et al. Safety and immunogenicity of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA 297 (2007) 1577-1582
15. 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
16. 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
17. 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
18. Genzel Y., Behrendt I., Konig S., Sann H., and Reichl U. Metabolism of MDCK cells during cell growth and influenza virus production in large-scale microcarrier culture. Vaccine 22 (2004) 2202-2208
19. Trusheim H., Roth B., Wilms R., Jung S., Muth R., Eggers M., et al. The MDCK 33016-PF cell-line is not only suitable for the production of cell-based influenza vaccine but it also an ideal substrate for influenza virus isolation. Poster Presented at Options for the Control of Influenza VI. Toronto, Canada, 17-23 June (2007)
20. World Health Organization. Recommended composition of influenza virus vaccines for use in the 2001-2002 season. Wkly Epidemiol Rec 76 (2001) 58-60
21. Oxford J.S., Yetts R., and Schild G.C. Quantitation and analysis of the specificity of post-immunization antibodies to influenza B viruses using single radial haemolysis. J Hyg (Lond) 88 (1982) 325-333
22. Schild G.C., Pereira M.S., and Chakraverty P. Single-radial-hemolysis: a new method for the assay of antibody to influenza haemagglutinin. Applications for diagnosis and seroepidemiologic surveillance of influenza. Bull World Health Organ 52 (1975) 43-50
23. Cooper C.L., Davis H.L., Morris M.L., Efler S.M., Krieg A.M., Li Y., et al. Safety and immunogenicity of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine. Vaccine 22 (2004) 3136-3143
24. ®. Vaccine 24 (2006) 1586-1592
25. Palache A.M., Brands R., and van Scharrenburg G.J. Immunogenicity and reactogenicity of influenza subunit vaccines produced in MDCK cells or fertilized chicken eggs. J Infect Dis 176 (1997) S20-S23
26. Halperin S.A., Nestruck A.C., and Eastwood B.J. Safety and immunogenicity of a new influenza vaccine grown in mammalian cell culture. Vaccine 16 (1998) 1331-1335
27. Percheson P.B., Trépanier P., Dugré R., and 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 (1999) 127-132
28. US Department of Health and Human Services. Vaccine production in cells. 2006. Available from URL: http://www.pandemicflu.gov/vaccine/vproductioncells.html [accessed 31 July, 2007].
29. Robertson J.S., Cook P., Attwell A., and Williams S.P. Replicative advantage in tissue culture of egg-adapted influenza virus over tissue-culture derived virus: implications for vaccine manufacture. Vaccine 16 (1995) 1583-1588
30. Harmon M.W., Rota P.A., Walls H.H., and Kendal A.P. Antibody response in humans to influenza virus type B host-cell-derived variants after vaccination with standard (egg-derived) vaccine or natural infection. J Clin Microbiol 26 (1988) 333-337
31. Katz J.M., Wang M., and Webster R.G. Direct sequencing of the HA gene of influenza (H3N2) virus in original clinical samples reveals sequence identity with mammalian cell-grown virus. J Virol 64 (1990) 1808-1811