A randomised, single-blind, dose-range study to assess the immunogenicity and safety of a cell-culture-derived A/H1N1 influenza vaccine in adult and elderly populations

Vaccine

Volumn 30, Issue 32, 2012, Pages 4820-4827

  Hatz, Christoph ^a,b   Cramer, Jakob P ^c   Vertruyen, André ^d   Schwarz, Tino F ^e   von Sonnenburg, Frank ^f   Borkowski, Astrid ^g   Lattanzi, Maria ^g   Hilbert, Anne Katrin ^g   Cioppa, Giovanni Della ^g   Leroux Roels, Geert ^h  

^a UNIVERSITY OF ZURICH   (Switzerland)

^b SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

^c UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^d Sint Vincentiusziekenhuis   (Belgium)

^e UNIVERSITY OF WÜRZBURG   (Germany)

^f UNIVERSITY OF MUNICH   (Germany)

^g NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^h GHENT UNIVERSITY   (Belgium)

Author keywords

Adjuvant; H1N1; Influenza; MF59; Pandemic

Indexed keywords

INFLUENZA VACCINE; MIFAMURTIDE;

ADULT; AGED; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BACKACHE; CHILL; CONTROLLED STUDY; CROSS REACTION; DIARRHEA; DRUG SAFETY; ECCHYMOSIS; FATIGUE; FEMALE; FEVER; GERIATRIC PATIENT; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE BLEEDING; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SWEATING; VACCINATION;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; ANTIBODIES, VIRAL; CELL CULTURE TECHNIQUES; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION, SECONDARY; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; POLYSORBATES; SINGLE-BLIND METHOD; SQUALENE; YOUNG ADULT;

EID: 84862524027     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.05.013     Document Type: Article

References (36)

1. World Health Organization. Global alert and response (GAR). Pandemic influenza vaccines: current status; 2009. http://www.who.int/csr/disease/swineflu/notes/pandemic_influenza_vaccines_20090924/en/index.html.
2. Erlewyn-Lajeunesse M., Brathwaite N., Lucas J.S., Warner J.O. Recommendations for the administration of influenza vaccine in children allergic to egg. BMJ 2009, 339:b3680.
3. World Health Organization. Global alert and response (GAR): WHO recommendations on pandemic (H1N1) 2009 vaccine. http://www.who.int/csr/disease/swineflu/notes/h1n1_vaccine_20090713/en/index.html.
4. Banzhoff A., Gasparini R., Laghi-Pasini F., Staniscia T., Durando P., Montomoli E., et al. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS ONE 2009, 4(2):e4384.
5. Bernstein D.I., Edwards K.M., Dekker C.L., Belshe R., Talbot H.K., Graham I.L., et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 2008, 197(March (5)):667-675.
6. Leroux-Roels I., Borkowski A., Vanwolleghem T., Drame M., Clement F., Hons E., et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007, 370(August (9587)):580-589.
7. Banzhoff A., Haertel S., Praus M. Passive surveillance of adverse events of an MF59-adjuvanted H1N1v vaccine during the pandemic mass vaccinations. Hum Vaccin 2011, 7(May (5)):539-548.
8. Crucitti A., Tsai T.F. Explorations of clinical trials and pharmacovigilance databases of MF59(R)-adjuvanted influenza vaccines for associated cases of narcolepsy: a six-month update. Scand J Infect Dis 2011, (August).
9. Tsai T.F., Crucitti A., Nacci P., Nicolay U., Cioppa G.D., 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(September (9)):702-706.
10. Galli G., Hancock K., Hoschler K., DeVos J., Praus M., Bardelli M., et al. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci USA 2009, 106(May (19)):7962-7967.
11. Stephenson I., Nicholson K.G., Hoschler K., Zambon M.C., Hancock K., DeVos J., et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. N Engl J Med 2008, 359(October (15)):1631-1633.
12. Beigel J.H., Voell J., Huang C.Y., Burbelo P.D., Lane H.C. Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine. J Infect Dis 2009, 200(August (4)):501-509.
13. Keitel W.A., Atmar R.L. Vaccines for pandemic influenza: summary of recent clinical trials. Curr Top Microbiol Immunol 2009, 333:431-451.
14. Treanor J.J., Campbell J.D., Zangwill K.M., Rowe T., Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006, 354(March (13)):1343-1351.
15. Clark T.W., Pareek M., Hoschler K., Dillon H., Nicholson K.G., Groth N., et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009, 361(December (25)):2424-2435.
16. Greenberg M.E., Lai M.H., Hartel G.F., Wichems C.H., Gittleson C., Bennet J., et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 2009, 361(December (25)):2405-2413.
17. Liang X.F., Wang H.Q., Wang J.Z., Fang H.H., Wu J., Zhu F.C., et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010, 375(January (9708)):56-66.
18. Plennevaux E., Sheldon E., Blatter M., Reeves-Hoche M.K., Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 2010, 375(January (9708)):41-48.
19. 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 2009, 200(September (6)):841-848.
20. Stephenson I., Nicholson K.G., Wood J.M., Zambon M.C., Katz J.M. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis 2004, 4(August (8)):499-509.
21. Nicholson K.G., Colegate A.E., Podda A., Stephenson I., Wood J., Ypma E., et al. Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet 2001, 357(June (9272)):1937-1943.
22. Bonhoeffer J., Bentsi-Enchill A., Chen R.T., Fisher M.C., Gold M.S., Hartman K., et al. Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies. Vaccine 2009, 27(April (16)):2282-2288.
23. Stohr K. Vaccinate before the next pandemic?. Nature 2010, 465(May (7295)):161.
24. Ulmer J.B., Valley U., Rappuoli R. Vaccine manufacturing: challenges and solutions. Nat Biotechnol 2006, 24(November (11)):1377-1383.
25. Reisinger K.S., Block S.L., Izu A., Groth N., Holmes S.J. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis 2009, 200(September (6)):849-857.
26. Committee for Medical Products for Human Use. Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application; 2008. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003993.pdf.
27. Madhun A.S., Akselsen P.E., Sjursen H., Pedersen G., Svindland S., Nostbakken J.K., et al. An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers. Vaccine 2010, 29(December (2)):266-273.
28. Nicholson K.G., Abrams K.R., Batham S., Clark T.W., Hoschler K., Lim W.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 2011, 11(February (2)):91-101.
29. O'Hagan D.T. MF59 is a safe and potent vaccine adjuvant that enhances protection against influenza virus infection. Expert Rev Vaccines 2007, 6(October (5)):699-710.
30. Khurana S., Chearwae W., Castellino F., Manischewitz J., King L.R., Honorkiewicz A., 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(January (15)):15ra5.
31. Khurana S., Verma N., Yewdell J.W., Hilbert A.K., Castellino F., Lattanzi M., et al. MF59 adjuvant enhances diversity and affinity of antibody-mediated immune response to pandemic influenza vaccines. Sci Transl Med 2011, 3(June (85)):85ra48.
32. Hancock K., Veguilla V., Lu X., Zhong W., Butler E.N., Sun H., et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009, 361(November (20)):1945-1952.
33. Del Giudice G., Stittelaar K.J., van Amerongen G., Simon J., Osterhaus A.D., Stohr K., et al. Seasonal influenza vaccine provides priming for A/H1N1 immunization. Sci Transl Med 2009, 1(December (12)):12re1.
34. Wei C.J., Boyington J.C., Dai K., Houser K.V., Pearce M.B., Kong W.P., et al. Cross-neutralization of 1918 and 2009 influenza viruses: role of glycans in viral evolution and vaccine design. Sci Transl Med 2010, 2(March (24)):24ra1.
35. Galli G., Medini D., Borgogni E., Zedda L., Bardelli M., Malzone C., et al. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci USA 2009, 106(March (10)):3877-3882.
36. Vesikari T., Groth N., Karvonen A., Borkowski A., Pellegrini M. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine 2009, 27(October (45)):6291-6295.