Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects

Vaccine

Volumn 32, Issue 39, 2014, Pages 5027-5034

  Frey, Sharon E ^a   Reyes, Mari Rose Aplasca De Los ^b   Reynales, Humberto ^c   Bermal, Nancy Nazaire ^d   Nicolay, Uwe ^d   Narasimhan, Vas ^d   Forleo Neto, Eduardo ^d   Arora, Ashwani Kumar ^d  

^a SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b RESEARCH INSTITUTE FOR TROPICAL MEDICINE   (Philippines)

^c Centro de Atencion e Investigación Médica   (Colombia)

^d Novartis Vaccines and Diagnostics Inc   (United States)

Author keywords

Adjuvant; Elderly; Influenza vaccine; MF59; Non inferiority; Superiority

Indexed keywords

INFLUENZA VACCINE; MIFAMURTIDE; IMMUNOLOGICAL ADJUVANT; MF59 OIL EMULSION; POLYSORBATE; SQUALENE; VACCINE; VIRUS ANTIBODY;

ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; ASTHMA; BRONCHITIS; CHILL; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIARRHEA; DRUG SAFETY; FATIGUE; FEMALE; GERIATRIC PATIENT; GUILLAIN BARRE SYNDROME; HEADACHE; HUMAN; IMMUNOGENICITY; IMMUNOLOGICAL PARAMETERS; INFLUENZA VIRUS A H3N2; INJECTION SITE PAIN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REACTOGENICITY; RHINOPHARYNGITIS; SEASONAL INFLUENZA; SWELLING; AGED; ANTIBODY PRODUCTION; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; HEMAGGLUTINATION INHIBITION TEST; IMMUNOLOGY; INFLUENZA, HUMAN; PHASE 2 CLINICAL TRIAL; SINGLE BLIND PROCEDURE;

ADJUVANTS, IMMUNOLOGIC; AGED; ANTIBODIES, VIRAL; ANTIBODY FORMATION; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; POLYSORBATES; SINGLE-BLIND METHOD; SQUALENE; VACCINE POTENCY;

EID: 84906079507     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.07.013     Document Type: Article

References (39)

1. CDC CDC influenza update for geriatricians and other clinicians caring for people 65 and older. 2012-2013 influenza season. Impact on the elderly, summary guidance 2012-2013, CDC, Available at 〈http://www.cdc.gov/flu/professionals/2012-2013-guidance-geriatricians.htm〉.
2. Goodwin K., Viboud C., Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine 2006, 24(8):1159-1169.
3. Jefferson T., Rivetti D., Rivetti A., Rudin M., Di Pietrantonj C., Demicheli V. Efficacy and effectiveness of influenza vaccines in elderly people: a systematic review. Lancet 2005, 366(9492):1165-1174.
4. ® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines 2013, 12(1):13-30.
5. O'Hagan D.T., 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(6):740-744.
6. Khurana S., Verma N., Yewdell J.W., et al. MF59 adjuvant enhances diversity and affinity of antibody-mediated immune response to pandemic influenza vaccine. Sci Transl Med 2011, 85:85r48.
7. Khurana S., Chearwae W., Castellino F., et al. Vaccines with MF59 adjuvant expand the antibody repertoire to target protective sites of pandemic avian H5N1 influenza virus. Sci Transl Med 2010, 2:15ra5.
8. Ansaldi F., Zancolli M., Durando P., Montomoli E., Sticchi L., Del Giudice G., et al. Antibody response against heterogeneous circulating influenza virus strains elicited by MF59- and non-adjuvanted vaccines during seasons with good or partial matching between vaccine strain and clinical isolates. Vaccine 2010, 28(25):4123-4129.
9. Baldo V., Baldovin T., Floreani A., Fragapane E., Trivello R. Response of influenza vaccines against heterovariant influenza virus strains in adults with chronic diseases. J Clin Immunol 2007, 27(5):542-547.
10. Del Giudice G., Hilbert A.K., Bugarini R., Minutello A., Popova O., Toneatto D., et al. 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(16):3063-3065.
11. Minutello M., Senatore F., Cecchinelli G., Bianchi M., Andreani T., Podda A., et al. Safety and immunogenicity of an inactivated subunit influenza virus vaccine combined with MF59 adjuvant emulsion in elderly subjects, immunized for three consecutive influenza seasons. Vaccine 1999, 17(2):99-104.
12. Puig Barbera J., Gonzalez Vidal D. MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. Expert Rev Vaccines 2007, 6(5):659-665.
13. Tsai T.F. MF59 adjuvanted seasonal and pandemic influenza vaccines. Yakugaku Zasshi 2011, 131(12):1733-1741.
14. McElhaney J., Beran J., Devaster J-M., Esen M., Launay O., Leroux-Roels G., et al. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis 2013, 13(6):485-496.
15. Banzhoff A., Nacci P., Podda A. A new MF59-adjuvanted influenza vaccine enhances the immune response in the elderly with chronic diseases: results from an immunogenicity meta-analysis. Gerontology 2003, 49(3):177-184.
16. Baldo V., Baldovin T., Floreani A., Carraro A.M., Trivello R. 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(20):3955-3961.
17. Vesikari T., Knuf M., Wutzler P., Karvonen A., Kieninger-Baum D., Schmitt H.J., et al. Oil-in-water emulsion adjuvant with influenza vaccine in young children. New Engl J Med 2011, 365(15):1406-1416.
18. Stephenson I., Nicholson K.G., Gluck R., Mischler R., Newman R.W., Palache A.M., et al. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 2003, 362:1959-1966.
19. Scheifele D.W., McNeil S.A., Ward B.J., Dionne M., Cooper C., Coleman B., et al. Safety, immunogenicity, and tolerability of three influenza vaccines in older adults: results of a randomized, controlled comparison. Hum Vaccin Immunother 2013, 9(11):1-14.
20. Van Buynder P.G., Konrad S., Van Buynder J.L., Brodkin E., Krajden M., Ramler G., et al. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine 2013, 31(51):6122-6128.
21. Bragstad K., Emborg H., Fischer T.K., Voldstedlund M., Gubbels S., Andersen B., et al. Low vaccine effectiveness against influenza A(H3N2) virus among elderly people in Denmark in 2012/13-a rapid epidemiological and virological assessment. Euro Surveill 2013, 18(6).
22. Castilla J., Martinez-Baz I., Martinez-Artola V., Reina G., Pozo F., Garcia Cenoz M., et al. Decline in influenza vaccine effectiveness with time after vaccination, Navarre, Spain, season 2011/12. Euro Surveill 2013, 18(5). [Article 3].
23. Kelvin D.J., Farooqui A. Extremely low vaccine effectiveness against influenza H3N2 in the elderly during the 2012/2013 flu season. J Infect Dev Countries 2013, 7(3):299-301.
24. Kissling E., Valenciano M., Larrauri A., Oroszi B., Cohen J.M., Nunes B., et al. Low and decreasing vaccine effectiveness against influenza A(H3) in 2011/12 among vaccination target groups in Europe: results from the I-MOVE multicentre case-control study. Euro Surveill 2013, 18(5).
25. Pebody R., Andrews N., McMenamin J., Durnall H., Ellis J., Thompson C.I., et al. Vaccine effectiveness of 2011/12 trivalent seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: evidence of waning intra-seasonal protection. Euro Surveill 2013, 18(5).
26. Rondy M., Puig-Barbera J., Launay O., Duval X., Castilla J., Guevara M., et al. 2011-12 seasonal influenza vaccines effectiveness against confirmed A(H3N2) influenza hospitalisation: pooled analysis from a European network of hospitals. A pilot study. PLoS One 2013, 8(4):e59681.
27. Smith D.J., Lapedes A.S., de Jong J.C., Bestebroer T.M., Rimmelzwaan G.F., Osterhaus A.D., et al. Mapping the antigenic and genetic evolution of influenza virus. Science 2004, 305(5682):371-376.
28. Mazick A., Gergonne B., Nielsen J., Wuillaume F., Virtanen M.J., Fouillet A., et al. Excess mortality among the elderly in 12 European countries, February and March 2012. Euro Surveill 2012, 17(14).
29. Turbelin C., Souty C., Pelat C., Hanslik T., Sarazin M., Blanchon T., et al. Age distribution of influenza like illness cases during post-pandemic A(H3N2): comparison with the twelve previous seasons, in France. PLoS One 2013, 8(6):e65919.
30. Baldo V., Baldovin T., Pellegrini M., Angiolelli G., Majori S., Floreani A., et al. Immunogenicity of three different influenza vaccines against homologous and heterologous strains in nursing home elderly residents. Clin Dev Immunol 2010, 2010:517198.
31. Schanzer D.L., Langley J.M., Tam T.W. Co-morbidities associated with influenza-attributed mortality, 1994-2000, Canada. Vaccine 2008, 26(36):4697-4703.
32. Mannino S., Villa M., Apolone G., Weiss N.S., Groth N., Aquino I., et al. Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy. Am J Epidemiol 2012, 176(6):527-533.
33. Fisman D.N., Tuite A.R. Estimation of the health impact and cost-effectiveness of influenza vaccination with enhanced effectiveness in Canada. PLoS One 2011, 6(11):e27420.
34. Nicol K.L. Heterogeneity of influenza case definitions and implications for interpreting and comparing studies. Vaccine 2006, 24:6726-6728.
35. McElhaney J.E., Beran J., Devaster J.M., Esen M., Launay O., Leroux-Roels G., et al. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013, 13(6):485-496.
36. Pellegrini M., Nicolay U., Lindert K., Groth N., Della Cioppa G. MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database. Vaccine 2009, 27(49):6959-6965.
37. Tsai T.F., Crucitti A., Nacci P., Nicolay U., Della Cioppa G., Ferguson J., et al. Explorations of clinical trials and pharmacovigilance databases of MF59(R)-adjuvanted influenza vaccines for associated cases of narcolepsy. Scand J Infect Dis 2011, 43(9):702-706.
38. Banzhoff A., Haertel S., Praus M. Passive surveillance of adverse events of an MF59-adjuvanted H1N1v vaccine during the pandemic mass vaccinations. Hum Vaccine 2011, 7(5):539-548.
39. Villa M., Black S., Groth N., Rothman K.J., Apolone G., Weiss N.S., et al. Safety of MF59-Adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in Northern Italy. Am J Epidemiol 2013, 178(7):1139-1145.