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Volumn 84, Issue 3, 2010, Pages 1237-1242

A single-dose influenza a (H5N1) vaccine safe and immunogenic in adult and elderly patients: An approach to pandemic vaccine development

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE;

EID: 73949156426     PISSN: 0022538X     EISSN: None     Source Type: Journal    
DOI: 10.1128/JVI.01894-09     Document Type: Article
Times cited : (21)

References (33)
  • 1
    • 33646549355 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: Phase I randomised trial
    • Bresson, J. L., C. Perronne, O. Launay, C. Gerdil, M. Saville, J. Wood, K. Höschler, and M. C. Zambon. 2006. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 367:1657-1664.
    • (2006) Lancet , vol.367 , pp. 1657-1664
    • Bresson, J.L.1    Perronne, C.2    Launay, O.3    Gerdil, C.4    Saville, M.5    Wood, J.6    Höschler, K.7    Zambon, M.C.8
  • 2
    • 33646375216 scopus 로고    scopus 로고
    • Flu-vaccine makers toil to boost supply
    • Dennis, C. 2006. Flu-vaccine makers toil to boost supply. Nature 440:1099.
    • (2006) Nature , vol.440 , pp. 1099
    • Dennis, C.1
  • 3
    • 73949117368 scopus 로고    scopus 로고
    • European Parliament. 28 November 2001. EC guide to good manufacturing practice (GMP), 4. Based upon directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 relating to medicinal products for human use, p. 67-128. European Parliament, Strasbourg, France.
    • European Parliament. 28 November 2001. EC guide to good manufacturing practice (GMP), vol. 4. Based upon directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 relating to medicinal products for human use, p. 67-128. European Parliament, Strasbourg, France.
  • 4
    • 45149129921 scopus 로고    scopus 로고
    • Ehrlich, H. J., M. Müller, H. M. Oh, P. A. Tambyah, C. Joukhadar, E. Montomoli, D. Fisher, G. Berezuk, S. Fritsch, A. Löw-Baselli, N. Vartian, R. Bobrovsky, B. G. Pavlova, E. M. Pöllabauer, O. Kistner, and P. N. Barrett. 2008. Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N. Engl. J. Med. 358:2573-2584.
    • Ehrlich, H. J., M. Müller, H. M. Oh, P. A. Tambyah, C. Joukhadar, E. Montomoli, D. Fisher, G. Berezuk, S. Fritsch, A. Löw-Baselli, N. Vartian, R. Bobrovsky, B. G. Pavlova, E. M. Pöllabauer, O. Kistner, and P. N. Barrett. 2008. Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N. Engl. J. Med. 358:2573-2584.
  • 5
    • 73949128430 scopus 로고    scopus 로고
    • European Committee for Proprietary Medicinal Products. 12 March 1997. Note for guidance on harmonization of requirements for influenza vaccines, March 1997 (CPMP/BWP/214/96). European Agency for the Evaluation of Medicinal Products, London, United Kingdom.
    • European Committee for Proprietary Medicinal Products. 12 March 1997. Note for guidance on harmonization of requirements for influenza vaccines, March 1997 (CPMP/BWP/214/96). European Agency for the Evaluation of Medicinal Products, London, United Kingdom.
  • 7
    • 69849087920 scopus 로고    scopus 로고
    • European pharmacopeia, p, European Directorate for the Quality of Medicines, Strasbourg, France
    • European Directorate for the Quality of Medicines. 2007. European pharmacopeia, p.3406-3407. European Directorate for the Quality of Medicines, Strasbourg, France.
    • (2007) European Directorate for the Quality of Medicines , pp. 3406-3407
  • 8
    • 73949157427 scopus 로고    scopus 로고
    • Guideline on adjuvants in vaccines for human use (CHMP/VEG/134716/2004)
    • London, United Kingdom
    • European Medicines Agency. 2005. Guideline on adjuvants in vaccines for human use (CHMP/VEG/134716/2004). European Medicines Agency, London, United Kingdom. http://www.emea.europa.eu/pdfs/human/vwp/13471604en.pdf.
    • (2005) European Medicines Agency
  • 9
    • 64549140108 scopus 로고    scopus 로고
    • 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
    • Fazekas, G., R. Martosne-Mendi, I. Jankovics, I. Szilvasy, and Z. Vajo. 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.
    • (2009) Clin. Vaccine Immunol , vol.16 , pp. 437-443
    • Fazekas, G.1    Martosne-Mendi, R.2    Jankovics, I.3    Szilvasy, I.4    Vajo, Z.5
  • 11
    • 0003640344 scopus 로고
    • Kendal, A. P, M. S. Pereira, and J. J. Skehel ed, Centers for Disease Control, Atlanta, GA
    • Kendal, A. P., M. S. Pereira, and J. J. Skehel (ed.). 1982. Concepts and procedures for laboratory based influenza surveillance. Centers for Disease Control, Atlanta, GA.
    • (1982) Concepts and procedures for laboratory based influenza surveillance
  • 13
    • 34547837401 scopus 로고    scopus 로고
    • Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: A randomised controlled trial
    • Leroux-Roels, I., A. Borkowski, T. Vanwolleghem, M. Dramé, F. Clement, E. Hons, J. M. Devaster, and G. Leroux-Roels. 2007. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 370:580-589.
    • (2007) Lancet , vol.370 , pp. 580-589
    • Leroux-Roels, I.1    Borkowski, A.2    Vanwolleghem, T.3    Dramé, M.4    Clement, F.5    Hons, E.6    Devaster, J.M.7    Leroux-Roels, G.8
  • 14
    • 33748447102 scopus 로고    scopus 로고
    • Lin, J., J. Zhang, X. Dong, H. Fang, J. Chen, N. Su, Q. Gao, Z. Zhang, Y. Liu, Z. Wang, M. Yang, R. Sun, C. Li, S. Lin, M. Ji, Y. Liu, X. Wang, J. Wood, Z. Feng, Y. Wang, and W. Yin. 2006. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 368:991-997.
    • Lin, J., J. Zhang, X. Dong, H. Fang, J. Chen, N. Su, Q. Gao, Z. Zhang, Y. Liu, Z. Wang, M. Yang, R. Sun, C. Li, S. Lin, M. Ji, Y. Liu, X. Wang, J. Wood, Z. Feng, Y. Wang, and W. Yin. 2006. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 368:991-997.
  • 15
    • 73949093578 scopus 로고
    • National Institute of Pharmacy, National Institute of Pharmacy, Budapest, Hungary
    • National Institute of Pharmacy. 1995. License number OGYI-T-8998/01. National Institute of Pharmacy, Budapest, Hungary.
    • (1995) License number OGYI-T-8998/01
  • 16
    • 47349124848 scopus 로고    scopus 로고
    • Nolan, T. M., P. C. Richmond, M. V. Skeljo, G. Pearce, G. Hartel, N. T. Formica, K. Höschler, J. Bennet, D. Ryan, K. Papanaoum, R. L. Basser, and M. C. Zambon. 2008. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine 26:4160-4167.
    • Nolan, T. M., P. C. Richmond, M. V. Skeljo, G. Pearce, G. Hartel, N. T. Formica, K. Höschler, J. Bennet, D. Ryan, K. Papanaoum, R. L. Basser, and M. C. Zambon. 2008. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine 26:4160-4167.
  • 17
    • 33745158157 scopus 로고
    • A simple method of estimating fifty per cent endpoints
    • Reed, L. J., and H. Muench. 1938. A simple method of estimating fifty per cent endpoints. Am. J. Hyg. 27:493-497.
    • (1938) Am. J. Hyg , vol.27 , pp. 493-497
    • Reed, L.J.1    Muench, H.2
  • 18
    • 0033041241 scopus 로고    scopus 로고
    • Rowe, T., R. A. Abernathy, J. Hu-Primmer, W. W. Thompson, X. Lu, W. Lim, K. Fukuda, N. J. Cox, and J. M. Katz. 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.
    • Rowe, T., R. A. Abernathy, J. Hu-Primmer, W. W. Thompson, X. Lu, W. Lim, K. Fukuda, N. J. Cox, and J. M. Katz. 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.
  • 19
    • 4043084994 scopus 로고    scopus 로고
    • Confronting the avian influenza threat: Vaccine development for a potential pandemic
    • Stephenson, I., K. G. Nicholson, J. M. Wood, M. C. Zambon, and J. M. Katz. 2004. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect. Dis. 4:499-509.
    • (2004) Lancet Infect. Dis , vol.4 , pp. 499-509
    • Stephenson, I.1    Nicholson, K.G.2    Wood, J.M.3    Zambon, M.C.4    Katz, J.M.5
  • 20
    • 34247880933 scopus 로고
    • Purified precipitated virus obtained by a new simple method
    • Takatsy, G. 1952. Purified precipitated virus obtained by a new simple method. Acta Med. Acad. Sci. Hung. 3:185-191.
    • (1952) Acta Med. Acad. Sci. Hung , vol.3 , pp. 185-191
    • Takatsy, G.1
  • 21
    • 33645399959 scopus 로고    scopus 로고
    • Treanor, J. J., J. D. Campbell, K. M. Zangwill, T. Rowe, and M. Wolff. 2006. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N. Engl. J. Med. 354:1343-1351.
    • Treanor, J. J., J. D. Campbell, K. M. Zangwill, T. Rowe, and M. Wolff. 2006. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N. Engl. J. Med. 354:1343-1351.
  • 22
    • 19944432232 scopus 로고    scopus 로고
    • Ungchusak, K., P. Auewarakul, S. F. Dowell, R. Kitphati, W. Auwanit, P. Puthavathana, M. Uiprasertkul, K. Boonnak, C. Pittayawonganon, N. J. Cox, S. R. Zaki, P. Thawatsupha, M. Chittaganpitch, R. Khontong, J. M. Simmerman, and S. Chunsutthiwat. 2005. Probable person-to-person transmission of avian influenza A (H5N1). N. Engl. J. Med. 352:333-340.
    • Ungchusak, K., P. Auewarakul, S. F. Dowell, R. Kitphati, W. Auwanit, P. Puthavathana, M. Uiprasertkul, K. Boonnak, C. Pittayawonganon, N. J. Cox, S. R. Zaki, P. Thawatsupha, M. Chittaganpitch, R. Khontong, J. M. Simmerman, and S. Chunsutthiwat. 2005. Probable person-to-person transmission of avian influenza A (H5N1). N. Engl. J. Med. 352:333-340.
  • 23
    • 73949109161 scopus 로고    scopus 로고
    • Draft guidance on clinical data needed to support the licensure of pandemic influenza vaccines, Washington, DC
    • U.S. Food and Drug Administration. 2007. Draft guidance on clinical data needed to support the licensure of pandemic influenza vaccines. U.S. Food and Drug Administration, Washington, DC. http://www.fda.gov/cber/ gdlns/panfluvac.htm.
    • (2007)
  • 24
    • 34247897126 scopus 로고    scopus 로고
    • Vajo, Z., L. Kosa, I. Visontay, M. Jankovics, and I. Jankovics. 2007. Inactivated whole virus influenza A (H5N1) vaccine. Emerg. Infect. Dis. 13:807-808.
    • Vajo, Z., L. Kosa, I. Visontay, M. Jankovics, and I. Jankovics. 2007. Inactivated whole virus influenza A (H5N1) vaccine. Emerg. Infect. Dis. 13:807-808.
  • 25
    • 66449109509 scopus 로고    scopus 로고
    • Vajo, Z., L. Kosa, I. Szilvasy, Z. Pauliny, K. Bartha, I. Visontay, M. Jankovics, A. Kis, and I. Jankovics. 2008. Yearly licensing studies from 1997-2007 of the inactivated whole virus seasonal influenza vaccine Fluval-a useful approach to pandemic vaccine development even in less well developed countries? Influenza Other Respir. Viruses 2:211-218.
    • Vajo, Z., L. Kosa, I. Szilvasy, Z. Pauliny, K. Bartha, I. Visontay, M. Jankovics, A. Kis, and I. Jankovics. 2008. Yearly licensing studies from 1997-2007 of the inactivated whole virus seasonal influenza vaccine Fluval-a useful approach to pandemic vaccine development even in less well developed countries? Influenza Other Respir. Viruses 2:211-218.
  • 26
    • 58149381672 scopus 로고    scopus 로고
    • Vajo, Z., L. Kosa, I. Szilvasy, Z. Pauliny, K. Bartha, I. Visontay, A. Kis, I. Tarjan, N. Rozsa, and I. Jankovics. 2008. Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children. Pediatr. Infect. Dis. J. 27:1052-1056.
    • Vajo, Z., L. Kosa, I. Szilvasy, Z. Pauliny, K. Bartha, I. Visontay, A. Kis, I. Tarjan, N. Rozsa, and I. Jankovics. 2008. Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children. Pediatr. Infect. Dis. J. 27:1052-1056.
  • 28
    • 0022651460 scopus 로고
    • Characterization and evaluation of monoclonal antibodies developed for typing influenza A and influenza B viruses
    • Walls, H. H., M. W. Harmon, J. J. Slagle, C. Stocksdale, and A. P. Kendal. 1986. Characterization and evaluation of monoclonal antibodies developed for typing influenza A and influenza B viruses. J. Clin. Microbiol. 23:240-245.
    • (1986) J. Clin. Microbiol , vol.23 , pp. 240-245
    • Walls, H.H.1    Harmon, M.W.2    Slagle, J.J.3    Stocksdale, C.4    Kendal, A.P.5
  • 29
    • 0017640515 scopus 로고
    • An improved single-radial-immunodiffusion technique for the assay of influenza haemagglutinin antigen: Application for potency determinations of inactivated whole virus and subunit vaccines
    • Wood, J. M., G. C. Schild, R. W. Newman, and V. Seagroatt. 1977. An improved single-radial-immunodiffusion technique for the assay of influenza haemagglutinin antigen: application for potency determinations of inactivated whole virus and subunit vaccines. J. Biol. Stand. 5:237-247.
    • (1977) J. Biol. Stand , vol.5 , pp. 237-247
    • Wood, J.M.1    Schild, G.C.2    Newman, R.W.3    Seagroatt, V.4
  • 30
    • 73949126835 scopus 로고    scopus 로고
    • World Health Organization. 13 June 2009, accession date. Cumulative number of confirmed human cases of avian influenza A (H5N1) reported to WHO. World Health Organization, Geneva, Switzerland. http://www.who.int/csr/ disease/avian-influenza/country/cases-table-2009-06-02/en/index.html.
    • World Health Organization. 13 June 2009, accession date. Cumulative number of confirmed human cases of avian influenza A (H5N1) reported to WHO. World Health Organization, Geneva, Switzerland. http://www.who.int/csr/ disease/avian-influenza/country/cases-table-2009-06-02/en/index.html.
  • 31
    • 73949141028 scopus 로고    scopus 로고
    • Tables on the clinical trials of pandemic influenza prototype vaccines. World Health Organization, Geneva, Switzerland
    • World Health Organization. 2009. Tables on the clinical trials of pandemic influenza prototype vaccines. World Health Organization, Geneva, Switzerland. http://www.who.int/vaccine-research/diseases/influenza/flu-trials- tables/en/index.html.
    • (2009)
  • 32
    • 73949111248 scopus 로고    scopus 로고
    • World Health Organization. 13 June 2007, posting date. WHO and manufacturers move ahead with plans for H5N1 influenza global vaccine stockpile. World Health Organization, Geneva, Switzerland. www.who.int/mediacentre/news/ statements/2007/s14/en/index.html.
    • World Health Organization. 13 June 2007, posting date. WHO and manufacturers move ahead with plans for H5N1 influenza global vaccine stockpile. World Health Organization, Geneva, Switzerland. www.who.int/mediacentre/news/ statements/2007/s14/en/index.html.
  • 33
    • 34848819983 scopus 로고    scopus 로고
    • Yang, Y., M. E. Halloran, J. D. Sugimoto, and I. M. Longini, Jr. 2007. Detecting human-to-human transmission of avian influenza A (H5N1). Emerg. Infect. Dis. 13:1348-1353.
    • Yang, Y., M. E. Halloran, J. D. Sugimoto, and I. M. Longini, Jr. 2007. Detecting human-to-human transmission of avian influenza A (H5N1). Emerg. Infect. Dis. 13:1348-1353.


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