Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: A phase II randomized, controlled trial of immunogenicity and safety in healthy adults

Journal of Infectious Diseases

Volumn 203, Issue 12, 2011, Pages 1719-1728

  Lopez, Pio ^a   Caicedo, Yolanda ^a   Sierra, Alexandra ^a   Tilman, Sandrine ^b   Banzhoff, Angelika ^c   Clemens, Ralf ^d  

^a Centro de Estudios en Infectologia Pediatrica   (Colombia)

^b Novartis Vaccines and Diagnostics   (Netherlands)

^c GSK Marburg Vaccines and Diagnostics   (Germany)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; SEASONAL INFLUENZA VACCINE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ECCHYMOSIS; FEASIBILITY STUDY; FEMALE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; IMMUNOGENICITY; INFLUENZA VACCINATION; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; VIRUS STRAIN;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ANTIBODIES, VIRAL; FEMALE; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; INJECTIONS, INTRAMUSCULAR; MALE; POLYSORBATES; SQUALENE; YOUNG ADULT;

EID: 79955114493     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jir191     Document Type: Article

References (36)

1. Gambotto A, Barratt-Boyes SM, de Jong MD, Neumann G, Kawaoka Y. Human infection with highly pathogenic H5N1 influenza virus. Lancet 2008; 37:1464-75. (Pubitemid 351618340)
2. Kuiken T, Taubenberger JK. Pathology of human influenza revisited. Vaccine 2008; 26(Suppl 4):D59-66.
3. Neumann G, Chen H, Gao GF, Shu Y, Kawaoka Y. H5N1 influenza viruses: outbreaks and biological properties. Cell Res 2010; 20:51-61.
4. World Health Organization. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO. Available at: http://www.who.int/csr/ disease/avian-influenza/country/cases-table-2010-10-18/en/index.html. Accessed 16 November 2010.
5. Montomoli E, Manini I. Pre-emptive vaccination against pandemic influenza virus. Vaccine 2007; 25:1921-2. (Pubitemid 46227671)
6. Osterhaus AD. Editorial: pre- or post-pandemic influenza vaccine? Vaccine 2007; 25:4983-4.
7. Hampson AW. Vaccines for pandemic influenza: the history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singapore 2008; 37:510-7.
8. Hessel L European Vaccine Manufacturers (EVM) Influenza Working Group. Pandemic influenza vaccines:meeting the supply, distribution and deployment challenges. Influenza Other Respi Viruses 2009; 3:165-70.
9. Palache B, Krause R. Progress with human H5N1 vaccines: a perspective from industry. Expert Rev Vaccines 2009; 8:391-400.
10. Sambhara S, Poland GA. H5N1 avian influenza: preventive and therapeutic strategies against a pandemic. Ann Rev Med 2010; 61:187-98.
11. 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; 2:243-9.
12. Bresson JL, Perronne C, Launay O, et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006; 367:1657-4.
13. Leroux-Roels I, Leroux-Roels G. Current status and progress of pre-pandemic and pandemic influenza vaccine development. Exp Rev Vacc 2009; 8:401-23.
14. Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006; 368:991-7. (Pubitemid 44353667)
15. Qiu YZ, Yin WD. Safety and immunogenicity of Sinovac's prototype pandemic influenza H5N1 vaccines: a review on clinical trials. Influenza Other Respi Viruses 2008; 2:237-42.
16. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006; 354:1343-51.
17. Bernstein DI, Edwards KM, Dekker CL, et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 2008; 197:667-75. (Pubitemid 351364465)
18. Stephenson I, Nicholson KG, Colegate A, et al. Boosting immunity to influenza H5N1 with MF59-adjuvanted H5N3 A/duck/Singapore/97 vaccine in a primed human population. Vaccine 2003; 21:1687-93. (Pubitemid 36287599)
19. Stephenson I, Bugarini R, Nicholson KG, 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; 191:1210-5.
20. Nicholson KG, Colegate AE, Podda A, 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; 357:1937-43. (Pubitemid 32568336)
21. Atmar RL, Keitel WA, Patel SM, et al. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis 2006; 43:1135-42. (Pubitemid 44632795)
22. Leroux-Roels I, Borkowski A, Vanwolleghem T, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370:580-9. (Pubitemid 47247854)
23. Stöhr K. Vaccinate before the next pandemic? Nature 2010; 465:161.
24. Vesikari T, Karvonen A, Tilman S, et al. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics 2010; 126:6762-70.
25. European Committee for Medicinal Products for Human Use (CHMP). Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (revision). EMEA/CPMP/VEG/4717/2003-Rev.1 2009. Derived from: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/09/WC500003869.pdf. London, UK, 2008.
26. Singleton, JA, Santibanez TA, Lu PJ, et al. Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage - United States, October-December 2009. MMWR 2010; 59:44-8.
27. Banzhoff A, Gasparini R, Laghi-Pasini F, et al. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One 2009; 4:e4384.
28. Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol 2010; 17:1817-9.
29. Galli G, Hancock K, Hoschler K, 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; 106:7962-7.
30. Sullivan JS, Selleck PW, Downton T. Heterosubtypic anti-avian H5N1 influenza antibodies in intravenous immunoglobulins from globally separate populations protect against H5N1 infection in cell culture. J Mol Genet Med 2009; 3:217-24.
31. Garcia JM, Pepin S, Lagarde N, et al. Heterosubtype neutralizing responses to influenza A (H5N1) viruses are mediated by antibodies to virus haemagglutinin. PLoS One 2009; 4:e7918.
32. 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.
33. Keitel W, Groth N, Lattanzi M, et al. Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: safety and immunogenicity of a phase 1/2 clinical trial. Vaccine 2010; 28:840-8.
34. 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; 27:6959-65.
35. Black S, Della Cioppa G, Malfroot A, et al. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine 2010; 28:7331-6.
36. Gasparini R, Schioppa F, Lattanzi M, et al. Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v (Focetria) in adult and elderly subjects. Int J Clin Prac 2010; 64:432-8.