An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/Chicken/Astana/6/ 05) influenza vaccine is safe and immunogenic in a single dose in humans

Clinical and Vaccine Immunology

Volumn 20, Issue 8, 2013, Pages 1314-1319

  Sansyzbay, Abylay R ^a   Erofeeva, Marianna K ^b   Khairullin, Berik M ^a   Sandybayev, Nurlan T ^a   Kydyrbayev, Zhailaubay K ^a   Mamadaliyev, Seidigapbar M ^a   Kassenov, Markhabat M ^a   Sergeeva, Maria V ^b   Romanova, Julia R ^b   Krivitskaya, Vera Z ^b   Kiselev, Oleg I ^b   Stukova, Marina A ^b  

^a The Research Institute for Biological Safety Problems   (Kazakhstan)

^b Research Institute of Influenza   (Russian Federation)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM HYDROXIDE; IMMUNOLOGICAL ADJUVANT; INACTIVATED VACCINE; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; NEUTRALIZING ANTIBODY; VIRUS ANTIBODY;

ADULT; ANIMAL CELL; ANTIBODY TITER; ARTICLE; CLADISTICS; CROSS REACTION; DEATH; DRUG DOSE COMPARISON; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; FEMALE; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; INFLUENZA VIRUS A H5N1; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; KAZAKHSTAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALAISE; MALE; NONHUMAN; NUCLEOTIDE SEQUENCE; PANDEMIC INFLUENZA; PRIORITY JOURNAL; RHINITIS; SEROCONVERSION; SINGLE DRUG DOSE; SORE THROAT; VIRAL GENETICS; VIRION; VIRUS ISOLATION; VIRUS NEUTRALIZATION; VIRUS STRAIN;

ADJUVANTS, IMMUNOLOGIC; ADULT; ALUMINUM HYDROXIDE; ANIMALS; ANTIBODIES, VIRAL; CROSS REACTIONS; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; KAZAKHSTAN; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; REVERSE GENETICS; RUSSIA; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 84880882139     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00096-13     Document Type: Article

References (30)

1. Obenauer JC, Denson J, Mehta PK, Su X, Mukatira S, Finkelstein DB, Xu X, Wang J, Ma J, Fan Y, Rakestraw KM, Webster RG, Hoffmann E, Krauss S, Zheng J, Zhang Z, Naeve CW. 2006. Large-scale sequence analysis of avian influenza isolates. Science 311:1576-1580.
2. Palese P, Wang TT. 2012. H5N1 influenza viruses: facts, not fear. Proc. Natl. Acad. Sci. U. S. A. 109:2211-2213.
3. Imai M, Watanabe T, Hatta M, Das SC, Ozawa M, Shinya K, Zhong G, Hanson A, Katsura H, Watanabe S, Li C, Kawakami E, Yamada S, Kiso M, Suzuki Y, Maher EA, Neumann G, Kawaoka Y. 2012. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 486:420-428.
4. Nichol KL, Treanor JJ. 2006. Vaccines for seasonal and pandemic influenza. J. Infect. Dis. 194(Suppl 2):S111-S118.
5. Monto AS. 2006. Vaccines and antiviral drugs in pandemic preparedness. Emerg. Infect. Dis. 12:55-60.
6. Schwartz B, Wortley P. 2006. Mass vaccination for annual and pandemic influenza. Curr. Top. Microbiol. Immunol. 304:131-152.
7. Prieto-Lara E, Llanos-Mendez A. 2010. Safety and immunogenicity of prepandemic H5N1 influenza vaccines: a systematic review of the literature. Vaccine 28:4328-4334.
8. Jennings LC, Monto AS, Chan PK, Szucs TD, Nicholson KG. 2008. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect. Dis. 8:650-658.
9. Germann TC, Kadau K, Longini IM Jr, Macken CA. 2006. Mitigation strategies for pandemic influenza in the United States. Proc. Natl. Acad. Sci. U. S. A. 103:5935-5940.
10. Chen H, Li Y, Li Z, Shi J, Shinya K, Deng G, Qi Q, Tian G, Fan S, Zhao H, Sun Y, Kawaoka Y. 2006. Properties and dissemination of H5N1 viruses isolated during an influenza outbreak in migratory waterfowl in western China. J. Virol. 80:5976-5983.
11. Robertson JS, Engelhardt OG. 2010. Developing vaccines to combat pandemic influenza. Viruses 2:532-546.
12. Horimoto T, Takada A, Fujii K, Goto H, Hatta M, Watanabe S, Iwatsuki-Horimoto K, Ito M, Tagawa-Sakai Y, Yamada S, Ito H, Ito T, Imai M, Itamura S, Odagiri T, Tashiro M, Lim W, Guan Y, Peiris M, Kawaoka Y. 2006. The development and characterization of H5 influenza virus vaccines derived from a 2003 human isolate. Vaccine 24:3669-3676.
13. Hoffmann E, Neumann G, Kawaoka Y, Hobom G, Webster RG. 2000. A DNA transfection system for generation of influenza A virus from eight plasmids. Proc. Natl. Acad. Sci. U. S. A. 97:6108-6113.
14. Kittel C, Sereinig S, Ferko B, Stasakova J, Romanova J, Wolkerstorfer A, Katinger H, Egorov A. 2004. Rescue of influenza virus expressing GFP from the NS1 reading frame. Virology 324:67-73.
15. Mamadaliyev MM, Sandybayev NT, Kydyrbayev ZK, Khairullin BM, Zaitsev VL, Mambetaliyev Kassenov MMM, Chervyakova OV, Ryskeldinova SZ, Volgin YN, Nurpeissova AS, Bogdanov NV, Sarsenbayeva GZ, Kisselyov OI, Tsybalova LM, Grudinin MP, Migunov AI, Stukova MA. 2011. Basic results of development of a production technology and control of a pandemic influenza A/H5N1 vaccine. Influenza Other Respi. Viruses 5(Suppl 1):1.
16. Hoffmann E, Stech J, Guan Y, Webster RG, Perez DR. 2001. Universal primer set for the full-length amplification of all influenza A viruses. Arch. Virol. 146:2275-2289.
17. Tamura K, Dudley J, Nei M, Kumar S. 2007. MEGA4: Molecular Evolutionary Genetics Analysis (MEGA) software version 4.0. Mol. Biol. Evol. 24:1596-1599.
18. Saitou N, Nei M. 1987. The neighbor-joining method: a new method for reconstructing phylogenetic trees. Mol. Biol. Evol. 4:406-425.
19. Zuckerkandl E, Pauling L. 1965. Molecules as documents of evolutionary history. J. Theor. Biol. 8:357-366.
20. Rowe T, Abernathy RA, Hu-Primmer J, Thompson WW, Lu X, Lim W, Fukuda K, Cox NJ, Katz JM. 1999. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J. Clin. Microbiol. 37:937-943.
21. Nicholson KG, Colegate AE, Podda A, Stephenson I, Wood J, Ypma E, Zambon MC. 2001. 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 357:1937-1943.
22. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. 2006. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N. Engl. J. Med. 354:1343-1351.
23. Treanor JJ, Wilkinson BE, Masseoud F, Hu-Primmer J, Battaglia R, O'Brien D, Wolff M, Rabinovich G, Blackwelder W, Katz JM. 2001. Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans. Vaccine 19:1732-1737.
24. Manzoli L, Schioppa F, Boccia A, Villari P. 2007. The efficacy of influenza vaccine for healthy children: a meta-analysis evaluating potential sources of variation in efficacy estimates, including study quality. Pediatr. Infect. Dis. J. 26:97-106.
25. Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. 2011. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J. Infect. Dis. 203:1729-1738.
26. Geeraedts F, Goutagny N, Hornung V, Severa M, de Haan A, Pool J, Wilschut J, Fitzgerald KA, Huckriede A. 2008. Superior immunogenicity of inactivated whole virus H5N1 influenza vaccine is primarily controlled by Toll-like receptor signalling. PLoS Pathog. 4(8):e1000138. doi:10.1371/journal.ppat.1000138.
27. Fazekas G, Martosne-Mendi R, Jankovics I, Szilvasy I, Vajo Z. 2009. Cross-reactive immunity to clade 2 strains of influenza virus A subtype H5N1 induced in adults and elderly patients by Fluval, a prototype pandemic influenza virus vaccine derived by reverse genetics, formulated with a phosphate adjuvant, and directed to clade 1 strains. Clin. Vaccine Immunol. 16:437-443.
28. Vajo Z, Wood J, Kosa L, Szilvasy I, Paragh G, Pauliny Z, Bartha K, Visontay I, Kis A, Jankovics I. 2010. A single-dose influenza A (H5N1) vaccine safe and immunogenic in adult and elderly patients: an approach to pandemic vaccine development. J. Virol. 84:1237-1242.
29. Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, Yang M, Sun R, Li C, Lin S, Ji M, Wang X, Wood J, Feng Z, Wang Y, Yin W. 2006. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 368:991-997.
30. Ehrlich HJ, Muller M, Oh HM, Tambyah PA, Joukhadar C, Montomoli E, Fisher D, Berezuk G, Fritsch S, Low-Baselli A, Vartian N, Bobrovsky R, Pavlova BG, Pollabauer EM, Kistner O, Barrett PN. 2008. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N. Engl. J. Med. 358:2573-2584.