메뉴 건너뛰기




Volumn 32, Issue 19, 2014, Pages 2251-2259

Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: A Phase 1 dose-escalation study in healthy adults

Author keywords

H1N1; Hemagglutinin; Influenza A; Plant produced; Recombinant vaccine

Indexed keywords

ALUMINUM HYDROXIDE; HEMAGGLUTININ; INFLUENZA VACCINE; MONOMER; RECOMBINANT VACCINE;

EID: 84897110525     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.10.017     Document Type: Article
Times cited : (73)

References (48)
  • 1
    • 77954162510 scopus 로고    scopus 로고
    • [accessed 26.3.12] World Health Organization Media Centre
    • World Health Organization Media Centre Influenza (Seasonal). Fact sheet No. 211 2009, http://www.who.int/mediacentre/factsheets/fs211/en/index.html [accessed 26.3.12].
    • (2009) Influenza (Seasonal). Fact sheet No. 211
  • 2
    • 67650407532 scopus 로고    scopus 로고
    • Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans
    • Garten R.J., Davis C.T., Russell C.A., Shu B., Lindstrom S., Balish A. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009, 325:197-201.
    • (2009) Science , vol.325 , pp. 197-201
    • Garten, R.J.1    Davis, C.T.2    Russell, C.A.3    Shu, B.4    Lindstrom, S.5    Balish, A.6
  • 3
    • 67449110743 scopus 로고    scopus 로고
    • Emergence of a novel swine-origin influenza A (H1N1) virus in humans
    • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team
    • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009, 360(25):2605-2615.
    • (2009) N Engl J Med , vol.360 , Issue.25 , pp. 2605-2615
  • 4
    • 70349873173 scopus 로고    scopus 로고
    • Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus
    • Hancock K., Veguilla V., Lu X., Zhong W., Butler E.N., Sun H., et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009, 361:1945-1952.
    • (2009) N Engl J Med , vol.361 , pp. 1945-1952
    • Hancock, K.1    Veguilla, V.2    Lu, X.3    Zhong, W.4    Butler, E.N.5    Sun, H.6
  • 5
    • 84897110512 scopus 로고    scopus 로고
    • [accessed 27.03.12]
    • WHO D-G statement 2009, http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html [accessed 27.03.12].
    • (2009) WHO D-G statement
  • 6
    • 68149119549 scopus 로고    scopus 로고
    • Egg-based production of influenza vaccine: 30 years of commercial experience
    • Matthews J.T. Egg-based production of influenza vaccine: 30 years of commercial experience. The Bridge (Nat Acad Eng) 2006, 36(3):17-24.
    • (2006) The Bridge (Nat Acad Eng) , vol.36 , Issue.3 , pp. 17-24
    • Matthews, J.T.1
  • 7
    • 77958193069 scopus 로고    scopus 로고
    • Influenza vaccines: the good, the bad, and the eggs
    • Schultz-Cherry S., Jones J.C. Influenza vaccines: the good, the bad, and the eggs. Adv Virus Res 2010, 77:63-84.
    • (2010) Adv Virus Res , vol.77 , pp. 63-84
    • Schultz-Cherry, S.1    Jones, J.C.2
  • 8
    • 80053413514 scopus 로고    scopus 로고
    • A systematic review of the evidence on the effectiveness and risks of inactivated influenza vaccines in different target groups
    • Michiels B., Govaerts F., Remmen R., Vermeire E., Coenen S. A systematic review of the evidence on the effectiveness and risks of inactivated influenza vaccines in different target groups. Vaccine 2011, 29(49):9159-9170.
    • (2011) Vaccine , vol.29 , Issue.49 , pp. 9159-9170
    • Michiels, B.1    Govaerts, F.2    Remmen, R.3    Vermeire, E.4    Coenen, S.5
  • 9
    • 84155162558 scopus 로고    scopus 로고
    • Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis
    • Osterholm M.T., Kelley N.S., Sommer A., Belongia E.A. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis 2012, 12(1):36-44.
    • (2012) Lancet Infect Dis , vol.12 , Issue.1 , pp. 36-44
    • Osterholm, M.T.1    Kelley, N.S.2    Sommer, A.3    Belongia, E.A.4
  • 11
    • 72949104686 scopus 로고    scopus 로고
    • Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial
    • Liang X.F., Wang H.Q., Wang J.Z., Fang H.H., Wu J., Zhu F.C., et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010, 375:56-66.
    • (2010) Lancet , vol.375 , pp. 56-66
    • Liang, X.F.1    Wang, H.Q.2    Wang, J.Z.3    Fang, H.H.4    Wu, J.5    Zhu, F.C.6
  • 12
    • 73049100357 scopus 로고    scopus 로고
    • Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials
    • Plennevaux E., Sheldon E., Blatter M., Reeves-Hoché M.K., Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 2010, 375:41-48.
    • (2010) Lancet , vol.375 , pp. 41-48
    • Plennevaux, E.1    Sheldon, E.2    Blatter, M.3    Reeves-Hoché, M.K.4    Denis, M.5
  • 13
    • 77958099793 scopus 로고    scopus 로고
    • A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults
    • Talaat K.R., Greenberg M.E., Lai M.H., Hartel G.F., Wichems C.H., Rockman S., et al. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis 2010, 202:1327-1337.
    • (2010) J Infect Dis , vol.202 , pp. 1327-1337
    • Talaat, K.R.1    Greenberg, M.E.2    Lai, M.H.3    Hartel, G.F.4    Wichems, C.H.5    Rockman, S.6
  • 15
    • 77954217881 scopus 로고    scopus 로고
    • Recombinant H1N1 virus-like particle vaccine elicits protective immunity in ferrets against the 2009 pandemic H1N1 influenza virus
    • Pushko P., Kort T., Nathan M., Pearce M.B., Smith G., Tumpey T.M., et al. Recombinant H1N1 virus-like particle vaccine elicits protective immunity in ferrets against the 2009 pandemic H1N1 influenza virus. Vaccine 2010, 28(30):4771-4776.
    • (2010) Vaccine , vol.28 , Issue.30 , pp. 4771-4776
    • Pushko, P.1    Kort, T.2    Nathan, M.3    Pearce, M.B.4    Smith, G.5    Tumpey, T.M.6
  • 16
    • 80053606312 scopus 로고    scopus 로고
    • Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico
    • López-Macías C., Ferat-Osorio E., Tenorio-Calvo A., Isibasi A., Talavera J., Arteaga-Ruiz O., et al. Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico. Vaccine 2011, 29(44):7826-7834.
    • (2011) Vaccine , vol.29 , Issue.44 , pp. 7826-7834
    • López-Macías, C.1    Ferat-Osorio, E.2    Tenorio-Calvo, A.3    Isibasi, A.4    Talavera, J.5    Arteaga-Ruiz, O.6
  • 17
    • 0006560198 scopus 로고    scopus 로고
    • [accessed 27.03.12] Protein Sciences Corp
    • Protein Sciences Corp White Paper 2011, http://www.proteinsciences.com/News/index.html#/16/ [accessed 27.03.12].
    • (2011) White Paper
  • 18
    • 79953697416 scopus 로고    scopus 로고
    • Clinical development of plant-produced recombinant pharmaceuticals: vaccines, antibodies and beyond
    • Yusibov V., Streatfield S.J., Kushnir N. Clinical development of plant-produced recombinant pharmaceuticals: vaccines, antibodies and beyond. Hum Vaccin 2011, 7:313-321.
    • (2011) Hum Vaccin , vol.7 , pp. 313-321
    • Yusibov, V.1    Streatfield, S.J.2    Kushnir, N.3
  • 19
    • 53849112341 scopus 로고    scopus 로고
    • Recent progress in the development of plant derived vaccines
    • Yusibov V., Rabindran S. Recent progress in the development of plant derived vaccines. Expert Rev Vaccines 2008, 7(8):1173-1183.
    • (2008) Expert Rev Vaccines , vol.7 , Issue.8 , pp. 1173-1183
    • Yusibov, V.1    Rabindran, S.2
  • 20
    • 70349759364 scopus 로고    scopus 로고
    • Plants as bioreactors: recent developments and emerging opportunities
    • Sharma A.K., Sharma M.K. Plants as bioreactors: recent developments and emerging opportunities. Biotechnol Adv 2009, 27(6):811-832.
    • (2009) Biotechnol Adv , vol.27 , Issue.6 , pp. 811-832
    • Sharma, A.K.1    Sharma, M.K.2
  • 21
    • 77953964469 scopus 로고    scopus 로고
    • The production of hemagglutinin-based virus-like particles in plants: a rapid, efficient and safe response to pandemic influenza
    • D'Aoust M.A., Couture M.M., Charland N., Trépanier S., Landry N., Ors F., et al. The production of hemagglutinin-based virus-like particles in plants: a rapid, efficient and safe response to pandemic influenza. Plant Biotechnol J 2010, 8:607-619.
    • (2010) Plant Biotechnol J , vol.8 , pp. 607-619
    • D'aoust, M.A.1    Couture, M.M.2    Charland, N.3    Trépanier, S.4    Landry, N.5    Ors, F.6
  • 22
    • 77953987341 scopus 로고    scopus 로고
    • Plant-made vaccines for humans and animals
    • Rybicki E.P. Plant-made vaccines for humans and animals. Plant Biotechnol J 2010, 8(5):620-637.
    • (2010) Plant Biotechnol J , vol.8 , Issue.5 , pp. 620-637
    • Rybicki, E.P.1
  • 24
    • 33947582603 scopus 로고    scopus 로고
    • A plant-produced plague vaccine candidate confers protection to monkeys
    • Mett V., Lyons J., Musiychuk K., Chichester J.A., Brasil T., Couch R., et al. A plant-produced plague vaccine candidate confers protection to monkeys. Vaccine 2007, 25:3014-3017.
    • (2007) Vaccine , vol.25 , pp. 3014-3017
    • Mett, V.1    Lyons, J.2    Musiychuk, K.3    Chichester, J.A.4    Brasil, T.5    Couch, R.6
  • 26
    • 58549091833 scopus 로고    scopus 로고
    • Plant-derived hemagglutinin protects ferrets against challenge infection with the A/Indonesia/05/05 strain of avian influenza
    • Shoji Y., Bi H., Musiychuk K., Rhee A., Horsey A., Roy G., et al. Plant-derived hemagglutinin protects ferrets against challenge infection with the A/Indonesia/05/05 strain of avian influenza. Vaccine 2009, 27:1087-1092.
    • (2009) Vaccine , vol.27 , pp. 1087-1092
    • Shoji, Y.1    Bi, H.2    Musiychuk, K.3    Rhee, A.4    Horsey, A.5    Roy, G.6
  • 28
    • 55949124182 scopus 로고    scopus 로고
    • Influenza virus-like particles produced by transient expression in Nicotiana benthamiana induce a protective immune response against a lethal viral challenge in mice
    • D'Aoust M.A., Lavoie P.O., Couture M.M., Trépanier S., Guay J.M., Dargis M., et al. Influenza virus-like particles produced by transient expression in Nicotiana benthamiana induce a protective immune response against a lethal viral challenge in mice. Plant Biotechnol J 2008, 6(9):930-940.
    • (2008) Plant Biotechnol J , vol.6 , Issue.9 , pp. 930-940
    • D'aoust, M.A.1    Lavoie, P.O.2    Couture, M.M.3    Trépanier, S.4    Guay, J.M.5    Dargis, M.6
  • 29
    • 39449113296 scopus 로고    scopus 로고
    • Novel controlled-release Lemna-derived IFN-alpha2b (Locteron): pharmacokinetics, pharmacodynamics, and tolerability in a phase I clinical trial
    • De Leede L.G., Humphries J.E., Bechet A.C., Van Hoogdalem E.J., Verrijk R., Spencer D.G. Novel controlled-release Lemna-derived IFN-alpha2b (Locteron): pharmacokinetics, pharmacodynamics, and tolerability in a phase I clinical trial. J Interferon Cytokine Res 2008, 28(2):113-122.
    • (2008) J Interferon Cytokine Res , vol.28 , Issue.2 , pp. 113-122
    • De Leede, L.G.1    Humphries, J.E.2    Bechet, A.C.3    Van Hoogdalem, E.J.4    Verrijk, R.5    Spencer, D.G.6
  • 30
    • 48249120731 scopus 로고    scopus 로고
    • Plant-produced idiotype vaccines for the treatment of non-Hodgkin's lymphoma: safety and immunogenicity in a phase I clinical study
    • McCormick A.A., Reddy S., Reinl S.J., Cameron T.I., Czerwinkski D.K., Vojdani F., et al. Plant-produced idiotype vaccines for the treatment of non-Hodgkin's lymphoma: safety and immunogenicity in a phase I clinical study. Proc Natl Acad Sci U S A 2008, 105(29):10131-10136.
    • (2008) Proc Natl Acad Sci U S A , vol.105 , Issue.29 , pp. 10131-10136
    • Mccormick, A.A.1    Reddy, S.2    Reinl, S.J.3    Cameron, T.I.4    Czerwinkski, D.K.5    Vojdani, F.6
  • 31
    • 78650981716 scopus 로고    scopus 로고
    • Preclinical and clinical development of plant-made virus-like particle vaccine against avian H5N1 influenza
    • Landry N., Ward B.J., Trépanier S., Montomoli E., Dargis M., Lapini G., et al. Preclinical and clinical development of plant-made virus-like particle vaccine against avian H5N1 influenza. PLoS ONE 2010, 5(12):e15559.
    • (2010) PLoS ONE , vol.5 , Issue.12
    • Landry, N.1    Ward, B.J.2    Trépanier, S.3    Montomoli, E.4    Dargis, M.5    Lapini, G.6
  • 32
    • 84897112009 scopus 로고    scopus 로고
    • [accessed 26.01.12]
    • Medicago Inc News release 2011, http://www.medicago.com/English/news/News-Releases/News-ReleaseDetails/2011/Medicago-to-present-additional-positive-clinical-data-at-the-2011ESWI-influenza-conference1126562/default.aspx [accessed 26.01.12].
    • (2011) Medicago Inc News release
  • 33
    • 82155184565 scopus 로고    scopus 로고
    • Pivotal trial with plant cell-expressed recombinant glucocerebrosidase, taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease
    • Zimran A., Brill-Almon E., Chertkoff R., Petakov M., Blanco-Favela F., Muñoz E.T., et al. Pivotal trial with plant cell-expressed recombinant glucocerebrosidase, taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease. Blood 2011, 118(22):5767-5773.
    • (2011) Blood , vol.118 , Issue.22 , pp. 5767-5773
    • Zimran, A.1    Brill-Almon, E.2    Chertkoff, R.3    Petakov, M.4    Blanco-Favela, F.5    Muñoz, E.T.6
  • 35
    • 84863393057 scopus 로고    scopus 로고
    • Plant-based rapid production of recombinant subunit hemagglutinin vaccines targeting H1N1 and H5N1 influenza
    • Shoji Y., Chichester J.A., Jones M., Manceva S.D., Damon E., Mett V. Plant-based rapid production of recombinant subunit hemagglutinin vaccines targeting H1N1 and H5N1 influenza. Hum Vaccin 2011, 7(Suppl.):41-50.
    • (2011) Hum Vaccin , vol.7 , Issue.SUPPL. , pp. 41-50
    • Shoji, Y.1    Chichester, J.A.2    Jones, M.3    Manceva, S.D.4    Damon, E.5    Mett, V.6
  • 36
    • 80053981428 scopus 로고    scopus 로고
    • [accessed 28.06.12] World Health Organization WHO Global Influenza Surveillance Network
    • World Health Organization WHO Global Influenza Surveillance Network Manual for the laboratory diagnosis and virological surveillance of influenza 2011, http://whqlibdoc.who.int/publications/2011/9789241548090_eng.pdf [accessed 28.06.12].
    • (2011) Manual for the laboratory diagnosis and virological surveillance of influenza
  • 38
    • 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 K.G., Thompson C.I., Klap J.M., Wood J.M., Batham S., Newman R.W., et al. Safety and immunogenicity of whole-virus, alum-adjuvanted whole-virus, virosomal, and whole-virus intradermal influenza A/H9N2 vaccine formulations. Vaccine 2010, 28:171-178.
    • (2010) 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
  • 39
    • 77955683120 scopus 로고    scopus 로고
    • A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial
    • Wu J., Li W., Wang H.Q., Chen J.T., Lv M., Zhou J.C., et al. A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis 2010, 202:675-680.
    • (2010) J Infect Dis , vol.202 , pp. 675-680
    • Wu, J.1    Li, W.2    Wang, H.Q.3    Chen, J.T.4    Lv, M.5    Zhou, J.C.6
  • 41
    • 40549088240 scopus 로고    scopus 로고
    • Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults
    • Bernstein D.I., Edwards K.M., Dekker C.L., Belshe R., Talbot H.K., Graham I.L., et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 2008, 197:667-675.
    • (2008) J Infect Dis , vol.197 , pp. 667-675
    • Bernstein, D.I.1    Edwards, K.M.2    Dekker, C.L.3    Belshe, R.4    Talbot, H.K.5    Graham, I.L.6
  • 42
    • 67650725154 scopus 로고    scopus 로고
    • Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults
    • Brady R.C., Treanor J.J., Atmar R.L., Keitel W.A., Edelman R., Chen W.H., et al. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults. Vaccine 2009, 27:5091-5095.
    • (2009) Vaccine , vol.27 , pp. 5091-5095
    • Brady, R.C.1    Treanor, J.J.2    Atmar, R.L.3    Keitel, W.A.4    Edelman, R.5    Chen, W.H.6
  • 43
    • 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., Perronne C., Launay O., Gerdil C., Saville M., Wood J., et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006, 367:1657-1664.
    • (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
  • 45
    • 54249154153 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial
    • Keitel W.A., Campbell J.D., Treanor J.J., Walter E.B., Patel S.M., He F., et al. Safety and immunogenicity of an inactivated influenza A/H5N1 vaccine given with or without aluminum hydroxide to healthy adults: results of a phase I-II randomized clinical trial. J Infect Dis 2008, 198:1309-1316.
    • (2008) J Infect Dis , vol.198 , pp. 1309-1316
    • Keitel, W.A.1    Campbell, J.D.2    Treanor, J.J.3    Walter, E.B.4    Patel, S.M.5    He, F.6
  • 46
    • 70350573451 scopus 로고    scopus 로고
    • Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults
    • Keitel W.A., Dekker C.L., Mink C., Campbell J.D., Edwards K.M., Patel S.M., et al. Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults. Vaccine 2009, 27:6642-6648.
    • (2009) Vaccine , vol.27 , pp. 6642-6648
    • Keitel, W.A.1    Dekker, C.L.2    Mink, C.3    Campbell, J.D.4    Edwards, K.M.5    Patel, S.M.6
  • 47
    • 47349124848 scopus 로고    scopus 로고
    • 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
    • Nolan T.M., Richmond P.C., Skeljo M.V., Pearce G., Hartel G., Formica N.T., et al. 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 2008, 26:4160-4167.
    • (2008) Vaccine , vol.26 , pp. 4160-4167
    • Nolan, T.M.1    Richmond, P.C.2    Skeljo, M.V.3    Pearce, G.4    Hartel, G.5    Formica, N.T.6
  • 48
    • 0029796717 scopus 로고    scopus 로고
    • In interleukin-4-deficient mice, alum not only generates T helper 1 responses equivalent to Freud's complete adjuvant, but continues to induce T helper 2 cytokine production
    • Brewer J.M., Conacher M., Satoskar A., Bluethmann H., Alexander J. In interleukin-4-deficient mice, alum not only generates T helper 1 responses equivalent to Freud's complete adjuvant, but continues to induce T helper 2 cytokine production. Eur J Immunol 1996, 26:2062-2066.
    • (1996) Eur J Immunol , vol.26 , pp. 2062-2066
    • Brewer, J.M.1    Conacher, M.2    Satoskar, A.3    Bluethmann, H.4    Alexander, J.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.