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Volumn 22, Issue 1, 2015, Pages 46-55

Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted Vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; NEUTRALIZING ANTIBODY; VIRUS ANTIBODY;

EID: 84920541055     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00275-14     Document Type: Article
Times cited : (10)

References (55)
  • 1
    • 42949111564 scopus 로고    scopus 로고
    • Human infection with highly pathogenic H5N1 influenza virus
    • Gambotto A, Barratt-Boyes SM, de Jong MD, Neumann G, Kawaoka Y. 2008. Human infection with highly pathogenic H5N1 influenza virus. Lancet 371: 1464-1475. http://dx.doi.org/10.1016/S0140-6736(08)60627-3.
    • (2008) Lancet , vol.371 , pp. 1464-1475
    • Gambotto, A.1    Barratt-Boyes, S.M.2    De Jong, M.D.3    Neumann, G.4    Kawaoka, Y.5
  • 5
    • 67649104447 scopus 로고    scopus 로고
    • World Health Organization, Geneva, Switzerland
    • World Health Organization. 2012. Pandemic influenza preparedness and response: a WHO guidance document. World Health Organization, Geneva, Switzerland. http://whqlibdoc.who.int/publications/2009/9789241547680-eng.pdf?ua-1.
    • (2012) Pandemic Influenza Preparedness and Response: A WHO Guidance Document
  • 11
    • 84865752791 scopus 로고    scopus 로고
    • Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: Homologous or heterologous booster response following two dose or single dose priming
    • van der Velden MV, Aichinger G, Pöllabauer EM, Löw-Baselli A, Fritsch S, Benamara K, Kistner O, Müller M, Zeitlinger M, Kollaritsch H, Vesikari T, Ehrlich HJ, Barrett PN. 2012. Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: homologous or heterologous booster response following two dose or single dose priming. Vaccine 30: 6127-6135. http://dx.doi.org/10.1016/j.vaccine.2012.07.077.
    • (2012) Vaccine , vol.30 , pp. 6127-6135
    • Van Der Velden, M.V.1    Aichinger, G.2    Pöllabauer, E.M.3    Löw-Baselli, A.4    Fritsch, S.5    Benamara, K.6    Kistner, O.7    Müller, M.8    Zeitlinger, M.9    Kollaritsch, H.10    Vesikari, T.11    Ehrlich, H.J.12    Barrett, P.N.13
  • 12
    • 79952206673 scopus 로고    scopus 로고
    • Phylogenetic diversity and genotypical complexity of H9N2 influenza A viruses revealed by genomic sequence analysis
    • Dong G, Luo J, Zhang H, Wang C, Duan M, Deliberto TJ, Nolte DL, Ji G, He H. 2011. Phylogenetic diversity and genotypical complexity of H9N2 influenza A viruses revealed by genomic sequence analysis. PLoS One 6: e17212. http://dx.doi.org/10.1371/journal.pone.0017212.
    • (2011) PLoS One , vol.6 , pp. e17212
    • Dong, G.1    Luo, J.2    Zhang, H.3    Wang, C.4    Duan, M.5    Deliberto, T.J.6    Nolte, D.L.7    Ji, G.8    He, H.9
  • 16
    • 79952774962 scopus 로고    scopus 로고
    • High genetic compatibility and increased pathogenicity of reassortants derived from avian H9N2 and pandemic H1N1/2009 influenza viruses
    • Sun Y, Qin K, Wang J, Pu J, Tang Q, Hu Y, Bi Y, Zhao X, Yang H, Shu Y, Liu J. 2011. High genetic compatibility and increased pathogenicity of reassortants derived from avian H9N2 and pandemic H1N1/2009 influenza viruses. Proc Natl Acad Sci U S A 108: 4164-4169. http://dx.doi.org/10.1073/pnas.1019109108.
    • (2011) Proc Natl Acad Sci U S A , vol.108 , pp. 4164-4169
    • Sun, Y.1    Qin, K.2    Wang, J.3    Pu, J.4    Tang, Q.5    Hu, Y.6    Bi, Y.7    Zhao, X.8    Yang, H.9    Shu, Y.10    Liu, J.11
  • 17
    • 0035866642 scopus 로고    scopus 로고
    • H9N2 influenza A viruses from poultry in Asia have human virus-like receptor specificity
    • Matrosovich MN, Krauss S, Webster RG. 2001. H9N2 influenza A viruses from poultry in Asia have human virus-like receptor specificity. Virology 281: 156-162. http://dx.doi.org/10.1006/viro.2000.0799.
    • (2001) Virology , vol.281 , pp. 156-162
    • Matrosovich, M.N.1    Krauss, S.2    Webster, R.G.3
  • 18
    • 34248366514 scopus 로고    scopus 로고
    • Amino acid 226 in the hemagglutinin of H9N2 influenza viruses determines cell tropism and replication in human airway epithelial cells
    • Wan H, Perez DR. 2007. Amino acid 226 in the hemagglutinin of H9N2 influenza viruses determines cell tropism and replication in human airway epithelial cells. J Virol 81: 5181-5191. http://dx.doi.org/10.1128/JVI.02827-06.
    • (2007) J Virol , vol.81 , pp. 5181-5191
    • Wan, H.1    Perez, D.R.2
  • 19
    • 66149130765 scopus 로고    scopus 로고
    • Minimal molecular constraints for respiratory droplet transmission of an avianhuman H9N2 influenza A virus
    • Sorrell EM, Wan H, Araya Y, Song H, Perez DR. 2009. Minimal molecular constraints for respiratory droplet transmission of an avianhuman H9N2 influenza A virus. Proc Natl Acad Sci U S A 106: 7565-7570. http://dx.doi.org/10.1073/pnas.0900877106.
    • (2009) Proc Natl Acad Sci U S A , vol.106 , pp. 7565-7570
    • Sorrell, E.M.1    Wan, H.2    Araya, Y.3    Song, H.4    Perez, D.R.5
  • 20
    • 0033809121 scopus 로고    scopus 로고
    • H9N2 influenza viruses possessing H5N1-like internal genomes continue to circulate in poultry in southeastern China
    • Guan Y, Shortridge KF, Krauss S, Chin PS, Dyrting KC, Ellis TM, Webster RG, Peiris M. 2000. H9N2 influenza viruses possessing H5N1-like internal genomes continue to circulate in poultry in southeastern China. J Virol 74: 9372-9380. http://dx.doi.org/10.1128/JVI.74.20.9372-9380.2000.
    • (2000) J Virol , vol.74 , pp. 9372-9380
    • Guan, Y.1    Shortridge, K.F.2    Krauss, S.3    Chin, P.S.4    Dyrting, K.C.5    Ellis, T.M.6    Webster, R.G.7    Peiris, M.8
  • 21
    • 67649968023 scopus 로고    scopus 로고
    • Novel genotypes of H9N2 influenza A viruses isolated from poultry in Pakistan containing NS genes similar to highly pathogenic H7N3 and H5N1 viruses
    • Iqbal M, Yaqub T, Reddy K, McCauley JW. 2009. Novel genotypes of H9N2 influenza A viruses isolated from poultry in Pakistan containing NS genes similar to highly pathogenic H7N3 and H5N1 viruses. PLoS One 4: e5788. http://dx.doi.org/10.1371/journal.pone.0005788.
    • (2009) PLoS One , vol.4 , pp. e5788
    • Iqbal, M.1    Yaqub, T.2    Reddy, K.3    McCauley, J.W.4
  • 22
    • 69249211158 scopus 로고    scopus 로고
    • A novel genotype H9N2 influenza virus possessing human H5N1 internal genomes has been circulating in poultry in eastern China since 1998
    • Zhang P, Tang Y, Liu X, Liu W, Zhang X, Liu H, Peng D, Gao S, Wu Y, Zhang L, Lu S, Liu X. 2009. A novel genotype H9N2 influenza virus possessing human H5N1 internal genomes has been circulating in poultry in eastern China since 1998. J Virol 83: 8428-8438. http://dx.doi.org/10.1128/JVI.00659-09.
    • (2009) J Virol , vol.83 , pp. 8428-8438
    • Zhang, P.1    Tang, Y.2    Liu, X.3    Liu, W.4    Zhang, X.5    Liu, H.6    Peng, D.7    Gao, S.8    Wu, Y.9    Zhang, L.10    Lu, S.11    Liu, X.12
  • 24
    • 79961092156 scopus 로고    scopus 로고
    • Compatibility of H9N2 avian influenza surface genes and 2009 pandemic H1N1 internal genes for transmission in the ferret model
    • Kimble JB, Sorrell E, Shao H, Martin PL, Perez DR. 2011. Compatibility of H9N2 avian influenza surface genes and 2009 pandemic H1N1 internal genes for transmission in the ferret model. Proc Natl Acad Sci U S A 108: 12084-12088. http://dx.doi.org/10.1073/pnas.1108058108.
    • (2011) Proc Natl Acad Sci U S A , vol.108 , pp. 12084-12088
    • Kimble, J.B.1    Sorrell, E.2    Shao, H.3    Martin, P.L.4    Perez, D.R.5
  • 25
    • 84894094300 scopus 로고    scopus 로고
    • Avian influenza A H10N8 - A virus on the verge?
    • García-Sastre A, Schmolke M. 2014. Avian influenza A H10N8-a virus on the verge? Lancet 383: 676-677. http://dx.doi.org/10.1016/S0140-6736(14)60163-X.
    • (2014) Lancet , vol.383 , pp. 676-677
    • García-Sastre, A.1    Schmolke, M.2
  • 26
    • 84895749932 scopus 로고    scopus 로고
    • Poultry carrying H9N2 act as incubators for novel human avian influenza viruses
    • Liu D, Shi W, Gao GF. 2014. Poultry carrying H9N2 act as incubators for novel human avian influenza viruses. Lancet 383: 869. http://dx.doi.org/10.1016/S0140-6736(14)60386-X.
    • (2014) Lancet , vol.383 , Issue.869
    • Liu, D.1    Shi, W.2    Gao, G.F.3
  • 28
    • 70849110714 scopus 로고    scopus 로고
    • Safety and immunogenicity of whole-virus, alum-adjuvanted whole-virus, virosomal, and whole-virus intradermal influenza A/H9N2 vaccine formulations
    • Nicholson KG, Thompson CI, Klap JM, Wood JM, Batham S, Newman RW, Mischler R, Zambon MC, Stephenson I. 2009. Safety and immunogenicity of whole-virus, alum-adjuvanted whole-virus, virosomal, and whole-virus intradermal influenza A/H9N2 vaccine formulations. Vaccine 28: 171-178. http://dx.doi.org/10.1016/j.vaccine.2009.09.103.
    • (2009) Vaccine , vol.28 , pp. 171-178
    • Nicholson, K.G.1    Thompson, C.I.2    Klap, J.M.3    Wood, J.M.4    Batham, S.5    Newman, R.W.6    Mischler, R.7    Zambon, M.C.8    Stephenson, I.9
  • 29
    • 10744232673 scopus 로고    scopus 로고
    • Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: Phase i randomised trial
    • Stephenson I, Nicholson KG, Glück R, Mischler R, Newman RW, Palache AM, Verlander NQ, Warburton F, Wood JM, Zambon MC. 2003. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 362: 1959-1966. http://dx.doi.org/10.1016/S0140-6736(03)15014-3.
    • (2003) Lancet , vol.362 , pp. 1959-1966
    • Stephenson, I.1    Nicholson, K.G.2    Glück, R.3    Mischler, R.4    Newman, R.W.5    Palache, A.M.6    Verlander, N.Q.7    Warburton, F.8    Wood, J.M.9    Zambon, M.C.10
  • 32
    • 0001312511 scopus 로고
    • Algorithm 183 An efficient and portable pseudo-random number generator
    • Wichmann BA, Hill ID. 1982. Algorithm 183. An efficient and portable pseudo-random number generator. Appl Stat 31: 188-190.
    • (1982) Appl Stat , vol.31 , pp. 188-190
    • Wichmann, B.A.1    Hill, I.D.2
  • 33
    • 79952100308 scopus 로고
    • Remark AS R58. A remark on algorithm AS 183. An efficient and portable pseudo-random number generator
    • McLeod A. 1985. Remark AS R58. A remark on algorithm AS 183. An efficient and portable pseudo-random number generator. Appl Stat 121: 811-822.
    • (1985) Appl Stat , vol.121 , pp. 811-822
    • McLeod, A.1
  • 35
    • 0003484310 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Veterinary Medicine, U.S. FDA, Silver Spring, MD
    • U.S. FDA. 2001. Guidance for industry: bioanalytical method validation U.S. Department of Health and Human Services, Center for Drug Evaluation and Research, Center for Veterinary Medicine, U.S. FDA, Silver Spring, MD. http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.
    • (2001) Guidance for Industry: Bioanalytical Method Validation
    • Fda, U.S.1
  • 36
    • 41849087128 scopus 로고    scopus 로고
    • ICH harmonised tripartite guideline: Validation of analytical procedures: Text and methodology
    • ICH, Geneva, Switzerland
    • ICH. 2005. ICH harmonised tripartite guideline: validation of analytical procedures: text and methodology. Q2(R1). International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Quality/Q2-R1/Step4/Q2-R1-Guideline.pdf.
    • (2005) Q2(R1). International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • 42
    • 0016589521 scopus 로고
    • Single-radial-hemolysis: A new method for the assay of antibody to influenza haemagglutinin. Applications for diagnosis and seroepidemiologic surveillance of influenza
    • Schild GC, Pereira MS, Chakraverty P. 1975. Single-radial-hemolysis: a new method for the assay of antibody to influenza haemagglutinin. Applications for diagnosis and seroepidemiologic surveillance of influenza. Bull World Health Organ 52: 43-50.
    • (1975) Bull World Health Organ , vol.52 , pp. 43-50
    • Schild, G.C.1    Pereira, M.S.2    Chakraverty, P.3
  • 43
    • 0029815056 scopus 로고    scopus 로고
    • Order-restricted tests for stratified comparisons of binomial proportions
    • Agresti A, Coull BA. 1996. Order-restricted tests for stratified comparisons of binomial proportions. Biometrics 52: 1103-1111. http://dx.doi.org/10.2307/2533072.
    • (1996) Biometrics , vol.52 , pp. 1103-1111
    • Agresti, A.1    Coull, B.A.2
  • 46
    • 77957701029 scopus 로고    scopus 로고
    • Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence
    • Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. 2010. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics 126: e762-e770. http://dx.doi.org/10.1542/peds.2009-2628.
    • (2010) Pediatrics , vol.126 , pp. e762-e770
    • Vesikari, T.1    Karvonen, A.2    Tilman, S.3    Borkowski, A.4    Montomoli, E.5    Banzhoff, A.6    Clemens, R.7
  • 48
    • 84864108343 scopus 로고    scopus 로고
    • Homologous and heterologous antibody responses to a one-year booster dose of an MF59 adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects
    • Vesikari T, Forstén A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. 2012. Homologous and heterologous antibody responses to a one-year booster dose of an MF59 adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother 8: 921-928. http://dx.doi.org/10.4161/hv.20248.
    • (2012) Hum Vaccin Immunother , vol.8 , pp. 921-928
    • Vesikari, T.1    Forstén, A.2    Borkowski, A.3    Gaitatzis, N.4    Banzhoff, A.5    Clemens, R.6
  • 50
    • 84901633378 scopus 로고    scopus 로고
    • EMA. European Medicines Agency, London, United Kingdom
    • EMA. 2012. EPAR summary for the public: Vepacel influenza vaccine (whole virion, inactivated). European Medicines Agency, London, United Kingdom. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Summary-for-the-public/human/002089/WC500124226.pdf.
    • (2012) EPAR Summary for the Public: Vepacel Influenza Vaccine (Whole Virion, Inactivated)
  • 51
    • 84874229387 scopus 로고    scopus 로고
    • Antibody correlates and predictors of immunity to naturally occurring influenza in humans and the importance of antibody to the neuraminidase
    • Couch RB, Atmar RL, Franco LM, Quarles JM, Wells J, Arden N, Niño D, Belmont JW. 2013. Antibody correlates and predictors of immunity to naturally occurring influenza in humans and the importance of antibody to the neuraminidase. J Infect Dis 207: 974-981. http://dx.doi.org/10.1093/infdis/jis935.
    • (2013) J Infect Dis , vol.207 , pp. 974-981
    • Couch, R.B.1    Atmar, R.L.2    Franco, L.M.3    Quarles, J.M.4    Wells, J.5    Arden, N.6    Niño, D.7    Belmont, J.W.8
  • 52
    • 84874698540 scopus 로고    scopus 로고
    • Neuraminidase-inhibiting antibody is a correlate of cross-protetion against lethal H5N1 influenza virus in ferrets immunized with seasonal influenza vaccine
    • Rockman S, Brown LE, Barr IG, Gilbertson B, Lowther S, Kachurin A, Kachurina O, Klippel J, Bodle J, Pearse M, Middleton D. 2013. Neuraminidase-inhibiting antibody is a correlate of cross-protetion against lethal H5N1 influenza virus in ferrets immunized with seasonal influenza vaccine. J Virol 87: 3053-3061. http://dx.doi.org/10.1128/JVI.02434-12.
    • (2013) J Virol , vol.87 , pp. 3053-3061
    • Rockman, S.1    Brown, L.E.2    Barr, I.G.3    Gilbertson, B.4    Lowther, S.5    Kachurin, A.6    Kachurina, O.7    Klippel, J.8    Bodle, J.9    Pearse, M.10    Middleton, D.11
  • 55
    • 84875964790 scopus 로고    scopus 로고
    • Vero cell culture-derived pandemic influenza vaccines: Preclinical and clinical development
    • Barrett PN, Portsmouth D, Ehrlich HJ. 2013. Vero cell culture-derived pandemic influenza vaccines: preclinical and clinical development. Expert Rev Vaccines 12: 395-413. http://dx.doi.org/10.1586/erv.13.21.
    • (2013) Expert Rev Vaccines , vol.12 , pp. 395-413
    • Barrett, P.N.1    Portsmouth, D.2    Ehrlich, H.J.3


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