A randomized clinical trial to identify the optimal antigen and MF59 ® adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects

Vaccine

Volumn 30, Issue 23, 2012, Pages 3470-3477

  Hatz, Christoph ^a,b   Von Sonnenburg, Frank ^c   Casula, Daniela ^d   Lattanzi, Maria ^d   Leroux Roels, Geert ^e  

^a UNIVERSITY OF ZURICH   (Switzerland)

^b SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

^c UNIVERSITY OF MUNICH   (Germany)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^e GHENT UNIVERSITY HOSPITAL   (Belgium)

Author keywords

Booster; Focetria; H1N1; Influenza; MF59; Vaccine

Indexed keywords

INFLUENZA VACCINE; MIFAMURTIDE;

ADULT; ARTHRALGIA; ARTICLE; CHILL; CONTROLLED STUDY; ECCHYMOSIS; ERYTHEMA; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HEMAGGLUTINATION; HUMAN; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOGENICITY; INFLUENZA A (H1N1); MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; NORMAL HUMAN; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEASONAL INFLUENZA; SIDE EFFECT; SINGLE BLIND PROCEDURE; SWEATING; SWELLING;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMAN EXPERIMENTATION; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; POLYSORBATES; SQUALENE; VACCINATION; YOUNG ADULT;

EID: 84859814732     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.03.017     Document Type: Article

References (43)

1. World Health Organization. World now at the start of 2009 influenza pandemic: . http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html.
2. 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.
3. World Health Organization. Pandemic (H1N1) 2009 briefing note 11: . http://www.who.int/csr/disease/swineflu/notes/pandemic_influenza_vaccines_20090924/en/index.html.
4. Alghisi F., Palma P., Montemitro E., Bernardi S., Pontrelli G., Rossi P., et al. Immunogenicity and safety profile of the monovalent A/H1N1 MF59-adjuvanted vaccine in patients affected by cystic fibrosis. Thorax 2011, 66(March (3)):259-260.
5. 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.
6. Esposito S., D'Angelo E., Daleno C., Peia F., Scala A., Serra D., et al. Immunogenicity, safety and tolerability of monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in patients with beta-thalassemia major. Vaccine 2010, 28(November (50)):7825-7828.
7. Esposito S., Meregalli E., Daleno C., Ghio L., Tagliabue C., Valzano A., et al. An open-label, randomized clinical trial assessing immunogenicity, safety and tolerability of pandemic influenza A/H1N1 MF59-adjuvanted vaccine administered sequentially or simultaneously with seasonal virosomal-adjuvanted influenza vaccine to paediatric kidney transplant recipients. Nephrol Dial Transplant 2011, 26(6):2018-2024.
8. Esposito S., Tagliaferri L., Daleno C., Valzano A., Picciolli I., Tel F., et al. Pandemic influenza A/H1N1 vaccine administered sequentially or simultaneously with seasonal influenza vaccine to HIV-infected children and adolescents. Vaccine 2011, 29(February (8)):1677-1682.
9. Kajaste-Rudnitski A., Galli L., Nozza S., Tambussi G., Di Pietro A., Pellicciotta G., et al. Induction of protective antibody response by MF59-adjuvanted 2009 pandemic A/H1N1v influenza vaccine in HIV-1-infected individuals. Aids 2011, 25(January (2)):177-183.
10. 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(November (49)):6959-6965.
11. Schultze V., D'Agosto V., Wack A., Novicki D., Zorn J., Hennig R. Safety of MF59 adjuvant. Vaccine 2008, 26(June (26)):3209-3222.
12. 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, (May).
13. Banzhoff A., Pellegrini M., Del Giudice G., Fragapane E., Groth N., Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respi Viruses 2008, 2(November (6)):243-249.
14. Durando P., Icardi G., Ansaldi F. MF59-adjuvanted vaccine: a safe and useful tool to enhance and broaden protection against seasonal influenza viruses in subjects at risk. Expert Opin Biol Ther 2010, 10(April (4)):639-651.
15. El Sahly H. MF59™ as a vaccine adjuvant: a review of safety and immunogenicity. Expert Rev Vaccines 2010, 9(October (10)):1135-1141.
16. O'Hagan D.T. MF59 is a safe and potent vaccine adjuvant that enhances protection against influenza virus infection. Expert Rev Vaccines 2007 Oct, 6(5):699-710.
17. Tsai T., Kyaw M.H., Novicki D., Nacci P., Rai S., Clemens R. Exposure to MF59-adjuvanted influenza vaccines during pregnancy - a retrospective analysis. Vaccine 2009, 28(February (7)):1877-1880.
18. Arguedas A., Soley C., Abdelnour A., Sales V., Lindert K., Cioppa G.D., et al. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin 2011, 7(January (1)):58-66.
19. Arguedas A., Soley C., Lindert K. Responses to 2009 H1N1 vaccine in children 3 to 17 years of age. N Engl J Med 2010, 362(January (4)):370-372.
20. Puig Barbera J., Gonzalez Vidal D. MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. Expert Rev Vaccines 2007, 6(October (5)):659-665.
21. 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 U S A 2009, 106(March (10)):3877-3882.
22. Ansaldi F., Bacilieri S., Durando P., Sticchi L., Valle L., Montomoli E., et al. Cross-protection by MF59-adjuvanted influenza vaccine: neutralizing and haemagglutination-inhibiting antibody activity against A(H3N2) drifted influenza viruses. Vaccine 2008, 26(March (12)):1525-1529.
23. 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.
24. 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 U S A 2009, 106(May (19)):7962-7967.
25. 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.
26. 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.
27. Stephenson I., Bugarini R., Nicholson K.G., Podda A., Wood J.M., Zambon M.C., et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J Infect Dis 2005, 191(April (8)):1210-1215.
28. World Health Organization. Availability of a candidate reassortant vaccine virus for the novel influenza A (H1N1) vaccine development X-179A: . http://www.who.int/csr/resources/publications/swineflu/candidates_X-179a/en/.
29. 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.
30. 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.
31. 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.
32. Committee for Medicinal 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.
33. 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.
34. Goodwin K., Viboud C., Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine 2006, 24(February (8)):1159-1169.
35. McElhaney J.E., Ewen C., Zhou X., Kane K.P., Xie D., Hager W.D., et al. Granzyme B: correlates with protection and enhanced CTL response to influenza vaccination in older adults. Vaccine 2009, 27(April (18)):2418-2425.
36. Nicholson K.G., Abrams K.R., Batham S., Clark T.W., Hoschler K., Lim W.S. 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.
37. Targonski P.V., Jacobson R.M., Poland G.A. Immunosenescence: role and measurement in influenza vaccine response among the elderly. Vaccine 2007, 25(April (16)):3066-3069.
38. Button R., Herlihy R., Rolfs R., Vernon V., Hill M., Price A., et al. Severe illness from 2009 pandemic influenza A (H1N1) - Utah, 2009-10 influenza season. MMWR Morb Mortal Wkly Rep 2011, 60(September (38)):1310-1314.
39. Fang Y., Banner D., Kelvin A.A., Huang S.S., Paige C.J., Corfe S.A., et al. Seasonal H1N1 influenza virus infection induces cross-protective pandemic H1N1 virus immunity through a CD8-independent, B cell-dependent mechanism. J Virol 2012, 86(February (4)):2229-2238.
40. 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.
41. 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(June (25)):4123-4129.
42. Beran J., Abdel-Messih I.A., Raupachova J., Hobzova L., Fragapane E. A phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses. Clin Ther 2010, 32(December (13)):2186-2197.
43. 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.