370
Views
53
CrossRef citations to date
0
Altmetric
Drug Evaluations

MF59-adjuvanted vaccine: a safe and useful tool to enhance and broaden protection against seasonal influenza viruses in subjects at risk

, MD PhD, , MD & , MD
Pages 639-651 | Published online: 11 Mar 2010

Bibliography

  • Nguyen-van-Tam JS, Nicholson KG. Influenza deaths in Leicestershire during the1989-90 epidemic: implications for prevention. Epidemiol Infect 1992;108:537-45
  • Sprenger MJ, Mulder PG, Beyer WE, Impact of influenza on mortality in relation to age and underlying disease, 1967-1989. Int J Epidemiol 1993;22:334-40
  • Thompson WW, Shay DK, Weintraub E, Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003;289:179-86
  • Yoshikawa TT. Epidemiology and unique aspects of aging and infectious diseases. Clin Infect Dis 2000;30:931-3
  • World Health Organization (WHO). Influenza vaccines. Wkly Epidemiol Rec 2005;80:279-87
  • Centers for Disease Control and Prevention (CDC). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;6:1-40
  • Centers for Disease Control and Prevention (CDC). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2009;58:RR-8
  • Neuzil KM, Wright PF, Mitchel EF, The burden of influenza illness in children with asthma and other chronic medical conditions. J Pediatr 2000;137:856–64
  • Neuzil KM, Mellen BG, Wright PF, The effect of influenza on hospitalizations, outpatient visits, and courses of antibiotics in children. N Engl J Med 2000;342:225–31
  • Izurieta HS, Thompson WW, Kramarz P, Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med 2000;342:232–9
  • World Health Organization (WHO). Fact sheet 2003;21. Available from: http://www.who.int/mediacentre/factsheets/fs211/en
  • Molinari NA, Ortega-Sanchez IR, Messonnier ML, The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine 2007;25:5086-96
  • Gasparini R, Lucioni C, Lai P, Cost-benefit evaluation of influenza vaccination in the elderly in the Italian region of Liguria. Vaccine 2002;20:B50-4
  • Italian Ministry of Welfare, Health and Social policies. Circular 23 July 2009 Prevenzione e controllo dell'influenza: raccomandazioni per la stagione 2009-2010. Available from: http://www.normativasanitaria.it/normsan-pdf/0000/29731_1.pdf. [Last accessed 10 February 2010]
  • Thompson WW, Shay DK, Weintraub E, Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003;289:179-86
  • Heikkinen T, Ruuskanen O. Effectiveness of influenza vaccine to prevent acute otitis media. JAMA 2004;291:692-3
  • Principi N, Esposito S, Marchisio P, Socioeconomic impact of influenza on healthy children and their families. Pediatr Infect Dis J 2003;22:S207-10
  • Gasparini R, Durando P, Ansaldi F, Influenza and respiratory syncytial virus in infants and children: relationship with attendance at a paediatric emergency unit and characteristics of the circulating strains. Eur J Clin Microbiol Infect Dis 2007;26:619-28
  • Poehling KA, Edwards KM, Weinberg GA, The underrecognized burden of infuenza in young children. N Engl J Med 2006;355:31–40
  • Nichol KL. The efficacy, effectiveness and cost-effectiveness of inactivated influenza virus vaccines. Vaccine 2003;21:1769-75
  • Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-8
  • Vu T, Farish S, Jenkins M, A meta-analysis of effectiveness of influenza vaccine in persons aged 65 years and over living in the community. Vaccine 2002;20:1831-6
  • Monto AS, Ansaldi F, Aspinall R, Influenza control in the 21st century: optimizing protection of older adults. Vaccine 2009;27:5043-53
  • Lazuardi L, Jenewein B, Wolf AM, Age-related loss of naïve T cells and dysregulation of T-cell/B-cell interactions in human lymph nodes. Immunology 2005;114:37-43
  • Podda A, Del Giudice G. MF59-adjuvanted vaccines: increased immunogenicity with an optimal safety profile. Expert Rev Vaccines 2003;2:197-203
  • Saurwein-Teissl M, Lung TL, Marx F, Lack of antibody production following immunization in old age: association with CD8(+)CD28(-) T cell clonal expansions and an imbalance in the production of Th1 and Th2 cytokines. J Immunol 2002;168:5893-9
  • Jefferson T. Influenza vaccination: policy versus evidence. BMJ 2006;333:912-5
  • Durando P, Fenoglio D, Boschini A, Safety and immunogenicity of two influenza virus subunit vaccines, with or without MF59 adjuvant, administered to human immunodeficiency virus type 1-seropositive and -seronegative adults. Clin Vaccine Immunol 2008;15:253-9
  • Iorio AM, Francisci D, Camilloni B, Antibody responses and HIV-1 viral load in HIV-1-seropositive subjects immunised with either the MF59-adjuvanted influenza vaccine or a conventional non-adjuvanted subunit vaccine during highly active antiretroviral therapy. Vaccine 2003;21:3629-37
  • Paschke R, Pollok M, Geiger H, Increased immunogenicity with an MF59-adjuvanted influenza vaccine compared to a conventional subunit vaccine in renal transplant recipients, J Prev Med Hyg 2003;44:79–84
  • Blumberg EA, Albano C, Pruett T, The immunogenicity of influenza virus vaccine in solid organ transplant recipients. Clin Infect Dis 1996;22:295-302
  • European Centre for Disease Prevention and Control (ECDC). Technical report on the scientific panel on vaccines and immunization. Infant and children seasonal immunization against infuenza on a routine basis during inter-pandemic period. Stockholm, 2007. Available from: http://www.ecdc.europa.eu/documents/pdf/Flu_vacc_18_Jan.pdf. [Last accessed 10 February 2010]
  • T. Jefferson, A. Rivetti, A. Harnden, Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev 2008;2:CD004879
  • Treanor JJ. Influenza vaccine—outmaneuvering antigenic shift and drift. N Engl J Med 2004;350:218-20
  • Carrat F, Flahault A. Influenza vaccine: the challenge of antigenic drift. Vaccine 2007;25:6852-62
  • Ansaldi F, Icardi G, Gasparini R, New A/H3N2 influenza variant: a small genetic evolution but a heavy burden on the Italian population during the 2004-2005 season. J Clin Microbiol 2005;43:3027-9
  • Ansaldi F, Bacilieri S, Durando P, Cross-protection by MF59-adjuvanted influenza vaccine: neutralizing and hemagglutination-inhibiting antibody activity against A(H3N2) drifted influenza viruses. Vaccine 2008;26:1525-9
  • Ansaldi F, Canepa P, Parodi V, Adjuvanted seasonal influenza vaccines and perpetual viralmetamorphosis: the importance of cross-protection. Vaccine 2009;27:3345-8
  • De Jong JC, Beyer WE, Palache AM, Mismatch between the 1997/1998 influenza vaccine and the major epidemic A(H3N2) virus strain as the cause of an inadequate vaccine-induced antibody response to this strain in the elderly. J Med Virol 2000;61:94-9
  • Legrand J, Vergu E, Flahault A. Real-time monitoring of the influenza vaccine field effectiveness. Vaccine 2006;24:6605-11
  • Skowronski DM, Masaro C, Kwindt TL, Estimating vaccine effectiveness against laboratory-confirmed influenza using a sentinel physician network: results from the 2005-2006 season of dual A and B vaccine mismatch in Canada. Vaccine 2007;25:2842-51
  • Centers for Disease Control and Prevention (CDC). Influenza. In: Atkinson W, Hamborsky J, McIntyre L, Wolfe S, editors. Epidemiology and prevention of vaccine-preventable diseases. 10th edition. Public Health Foundation, Washington, DC; 2007b. p. 235-56
  • Fedson DS. Preparing for pandemic vaccination: an international policy agenda for vaccine development. J Public Health Policy 2005;26:4-29
  • Doherty PC, Kelso A. Toward a broadly protective influenza vaccine. J Clin Invest 2008;118:3273-5
  • Belshe RB, Nichol KL, Black SB, Safety, efficacy, and effectiveness of live, attenuated, cold-adapted influenza vaccine in an indicated population aged 5-49 years. Clin Infect Dis 2004;39:920-7
  • Holland D, Booy R, De Looze F, Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis 2008;198:650-8
  • Keitel WA, Atmar RL, Cate TR, Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med 2006;166:1121-7
  • de B, Zanasi A, Ragusa S, An open-label comparison of the immunogenicity and tolerability of intranasal and intramuscular formulations of virosomal influenza vaccine in healthy adults. Clin Ther 2002;24:100-11
  • Arnou R, Icardi G, De Decker M, Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. Vaccine 2009;27:7304-12
  • Mutsch M, Zhou W, Rhodes P, Use of the inactivated intranasal influenza vaccine and the risk of Bell's palsy in Switzerland. N Engl J Med 2004;350:896-903
  • Belshe RB, Edwards KM, Vesikari T, Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 2007;356:685-96
  • Ohmit SE, Victor JC, Rotthoff JR, Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med 2006;355:2513-22
  • Beran J, Ambrozaitis A, Laiskonis A, Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med 2009;7:13
  • Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/intanza/H-957-en6.pdf. [Last accessed 10 February 2010]
  • Bruzzone B, Crovari P, Durando P, Influenza vaccination: advantages of new generation carriers. Ann Ig 2002;14:11-8
  • Herzog C, Hartmann K, Künzi V, Eleven years of Inflexal V-a virosomal adjuvanted influenza vaccine. Vaccine 2009;27:4381-7
  • Conne P, Gauthey L, Vernet P, Immunogenicity of trivalent subunit versus virosome-formulated influenza vaccines in geriatric patients. Vaccine 1997;15:1675-9
  • Glück R, Mischler R, Finkel B, Immunogenicity of new virosome influenza vaccine in elderly people. Lancet 1994;344:160-3
  • Ruf BR, Colberg K, Frick M, Open, randomized study to compare the immunogenicity and reactogenicity of an influenza split vaccine with an MF59-adjuvanted subunit vaccine and a virosome-based subunit vaccine in elderly. Infection 2004;32:191-8
  • Baldo V, Menegon T, Bonello C, Comparison of three different influenza vaccines in institutionalised elderly. Vaccine 2001;19:3472-5
  • Pregliasco F, Mensi C, Serpilli W, Immunogenicity and safety of three commercial influenza vaccines in institutionalized elderly. Aging 2001;13:38-43
  • de Bruijn IA, Meyer I, Gerez L, Antibody induction by virosomal, MF59-adjuvanted, or conventional influenza vaccines in the elderly. Vaccine 2007;26:119-27
  • de Bruijn IA, Nauta J, Cramer WC, Clinical experience with inactivated, virosomal influenza vaccine. Vaccine 2005;23:S39-49
  • Huckriede A, Bungener L, Stegmann T, The virosome concept for influenza vaccines. Vaccine 2005;23:S26-38
  • Kanra G, Marchisio P, Feiterna-Sperling C, Comparison of immunogenicity and tolerability of a virosome-adjuvanted and a split influenza vaccine in children. Pediatr Infect Dis J 2004;23:300-6
  • Baldo V, Baldovin T, Floreani A, MF59-adjuvanted influenza vaccine confers superior immunogenicity in adult subjects (18-60 years of age) with chronic diseases who are at risk of post-influenza complications. Vaccine 2007;25:3955-61
  • Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine 2001;19:2673-80
  • Gasparini R, Pozzi T, Montomoli E, Increased immunogenicity of the MF59-adjuvanted influenza vaccine compared to a conventional subunit vaccine in elderly subjects. Eur J Epidemiol 2001;17:135-40
  • Squarcione S, Sgricia S, Biasio LR, Comparison of the reactogenicity and immunogenicity of a split and a subunit-adjuvanted influenza vaccine in elderly subjects. Vaccine 2003;21:1268-74
  • Banzhoff A, Nacci P, Podda A. A new MF59-adjuvanted influenza vaccine enhanced the immune response in the elderly with chronic diseases: results from an immunogenicity meta-analysis. Gerontology 2003;49:177-84
  • Vesikari T, Pellegrini M, Karvonen A, Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J 2009;28:563-71
  • Vesikari T, Groth N, Karvonen A, MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine 2009;27:6291-5
  • Baldo V, Baldovin T, Floreani A, Response of influenza vaccines against heterovariant influenza virus strains in adults with chronic diseases. J Clin Immunol 2007;27:542-7
  • Del Giudice G, Hilbert AK, Bugarini R, An MF59-adjuvanted inactivated influenza vaccine containing A/Panama/1999 (H3N2) induced broader serological protection against heterovariant influenza virus strain A/Fujian/2002 than a subunit and a split influenza vaccine. Vaccine 2006;24:3063-5
  • Nicholson KG, Colegate AE, Podda A, Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenzaA/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet 2001;357:1937-43
  • Clark TW, Pareek M, Hoschler K, Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009;361:2424-35
  • Chu DW, Hwang SJ, Lim FS, Immunogenicity and tolerability of an AS03(A) adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine 2009;27:7428-35
  • Roman F, Vaman T, Gerlach B, Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03(A)-adjuvant: preliminary report of an observer-blind, randomised trial. Vaccine 2010;28(7):1740-5
  • Leroux-Roels I, Roman F, Forgus S, Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study. Vaccine 2010;28:849-57
  • Leroux-Roels I, Clement F, Leroux-Roels G, Adjuvanted influenza vaccines improve anti-influenza cellular mediated immunity impaired in elderly. Poster presented at Influenza Vaccines for the World; 18 – 20 October 2006a; Vienna, Austria
  • Leroux-Roels I, Oostvogels L, Hons E, Reactogenicity and safety of adjuvanted influenza vaccines administered in elderly. Poster presented at Influenza Vaccines for the World; 18 – 20 October 2006b; Vienna, Austria
  • O'Hagan DT. MF59 is a safe and potent vaccine adjuvant that enhances protection against influenza virus infection. Expert Rev Vaccines 2007;6:699-710
  • O'Hagan DT, Wack A, Podda A. MF59 is a safe and potent vaccine adjuvant for flu vaccines in humans: what did we learn during its development? Clin Pharmacol Ther 2007;82:740-4
  • Mosca F, Tritto E, Muzzi A, Molecular and cellular signatures of human vaccine adjuvants. Proc Natl Acad Sci USA 2008;105:10501-6
  • Seubert A, Monaci E, Pizza M, The adjuvants aluminum hydroxide and MF59 induce monocyte and granulocyte chemoattractants and enhance monocyte differentiation toward dendritic cells. J Immunol 2008;180:5402-12
  • Schultze V, D'Agosto V, Wack A, Safety of MF59 adjuvant. Vaccine 2008;26:3209-22
  • Minutello M, Senatore F, Cecchinelli G, Safety and immunogenicity of an inactivated subunit influenza virusvaccine combined with MF59 adjuvant emulsion in elderly subjects, immunized forthree consecutive influenza seasons. Vaccine 1999;17:99-104
  • Ansaldi F, Bacilieri S, Banfi F, Neutralizing and hemagglutination-inhibiting activities of antibodies elicited by the 2004-2005 influenza vaccine against drifted viruses. Clin Vaccine Immunol 2006;13:162–4
  • Puig-Barberà J, Diez-Domingo J, Pérez Hoyos S, Effectiveness of the MF59-adjuvanted influenza vaccine in preventing emergency admissions for pneumonia in the elderly over 64 years of age. Vaccine 2004;23:283-9
  • Puig-Barberà J, Díez-Domingo J, Varea AB, Effectiveness of MF59-adjuvanted subunit influenza vaccine in preventing hospitalisations for cardiovascular disease, cerebrovascular disease and pneumonia in the elderly. Vaccine 2007;25:7313-21
  • Iob A, Brianti G, Zamparo E, Evidence of increased clinical protection of an MF59-adjuvant influenza vaccine compared to a non-adjuvanted vaccine among elderly residents of long-term care facilities in Italy. Epidemiol Infect 2005;133:687-93
  • Italian Ministry of Health. Announcement n.27, 4 February 2010. Influenza A/H1N1: il punto della situazione alla settimana 4 (25-31 gennaio 2010). Available from: http://www.nuovainfluenza.salute.gov.it/nuovainfluenza/nuovaInfluenza.jsp. [Last accessed 10 February 2010]
  • Asa PB, Cao Y, Garry RF. Antibodies to squalene in Gulf War syndrome. Exp Mol Pathol 2000;68:55-64
  • Del Giudice G, Fragapane E, Bugarini R, Vaccines with the MF59 adjuvant do not stimulate antibody responses against squalene. Clin Vaccine Immunol. 2006;13:1010-3
  • Carlson BC, Jansson AM, Larsson A, The endogenous adjuvant squalene can induce a chronic T-cell-mediated arthritis in rats. Am J Pathol 2000;156:2057-65
  • Holm BC, Svelander L, Bucht A, The arthritogenic adjuvant squalene does not accumulate in joints, but gives rise to pathogenic cells in both draining and non-draining lymph nodes. Clin Exp Immunol 2002;127:430-5
  • Satoh M, Kuroda Y, Yoshida H, Induction of lupus autoantibodies by adjuvants. J Autoimmun 2003;21:1-9
  • Novartis. Vaccine and diagnostics. Data on file; 2007
  • Frey S, Poland G, Percell S, Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults. Vaccine 2003;21:4234-7
  • Pellegrini M, Nicolay U, Lindert K, MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database. Vaccine 2009;27:6959-65
  • Barberà JP. MF59-adjuvanted seasonal influenza vaccine. Aging health 2009;5:475-81
  • Keren G, Segev S, Morag A, Failure of influenza vaccination in the aged. J Med Virol 1988;25:85-9
  • Phair J, Kauffman CA, Bjornson A, Failure to respond to influenza vaccine in the aged: correlation with B-cell number and function. J Lab Clin Med 1978;92:822-8
  • Strassburg MA, Greenland S, Sorvillo FJ, Influenza in the elderly: report of an outbreak and a review of vaccine effectiveness reports. Vaccine 1986;4:38-44
  • European Medicines Agency (EMA). Focetria, pandemic influenza vaccine (surface antigen, inactivated, adjuvanted) A/California/7/2009 (H1N1). Available from: http://www.emea.europa.eu/influenza/vaccines/focetria/focetria_pi.html. [Last accessed 10 February 2010]

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.