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Volumn 28, Issue 13, 2010, Pages 2565-2572

Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin

Author keywords

DNA vaccine; H5N1 influenza virus; Vaxfectin

Indexed keywords

DNA VACCINE; INFLUENZA VACCINE; INFLUENZA VACCINE ADJUVANTED PLASMID DNA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; PLACEBO; TRIPLE VACCINE; UNCLASSIFIED DRUG; VAXFECTIN;

EID: 77649188963     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.01.029     Document Type: Article
Times cited : (123)

References (27)
  • 2
    • 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 367 (2006) 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
  • 3
    • 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 198 (2008) 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
  • 4
    • 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 26 (2008) 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
  • 5
    • 33645399959 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine
    • Treanor J.J., Campbell J.D., Zangwill K.M., Rowe T., and Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 354 (2006) 1343-1351
    • (2006) N Engl J Med , vol.354 , pp. 1343-1351
    • Treanor, J.J.1    Campbell, J.D.2    Zangwill, K.M.3    Rowe, T.4    Wolff, M.5
  • 6
    • 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.B., Graham I.L., et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 197 (2008) 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.B.5    Graham, I.L.6
  • 8
    • 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., Borkowski A., Vanwolleghem T., Drame M., Clement F., Hons E., et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 370 (2007) 580-589
    • (2007) Lancet , vol.370 , pp. 580-589
    • Leroux-Roels, I.1    Borkowski, A.2    Vanwolleghem, T.3    Drame, M.4    Clement, F.5    Hons, E.6
  • 9
    • 50949104571 scopus 로고    scopus 로고
    • An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults
    • Levie K., Leroux-Roels I., Hoppenbrouwers K., Kervyn A.D., Vandermeulen C., Forgus S., et al. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis 198 (2008) 642-649
    • (2008) J Infect Dis , vol.198 , pp. 642-649
    • Levie, K.1    Leroux-Roels, I.2    Hoppenbrouwers, K.3    Kervyn, A.D.4    Vandermeulen, C.5    Forgus, S.6
  • 10
    • 35348880906 scopus 로고    scopus 로고
    • Preparing for a possible pandemic: influenza A/H5N1 vaccine development
    • Keitel W.A., and Atmar R.L. Preparing for a possible pandemic: influenza A/H5N1 vaccine development. Curr Opin Pharmacol 7 (2007) 484-490
    • (2007) Curr Opin Pharmacol , vol.7 , pp. 484-490
    • Keitel, W.A.1    Atmar, R.L.2
  • 11
    • 0036686714 scopus 로고    scopus 로고
    • DNA vaccine expressing conserved influenza virus proteins protective against H5N1 challenge infection in mice
    • Epstein S.L., Tumpey T.M., Misplon J.A., Lo C.Y., Cooper L.A., Subbarao K., et al. DNA vaccine expressing conserved influenza virus proteins protective against H5N1 challenge infection in mice. Emerg Infect Dis 8 (2002) 796-801
    • (2002) Emerg Infect Dis , vol.8 , pp. 796-801
    • Epstein, S.L.1    Tumpey, T.M.2    Misplon, J.A.3    Lo, C.Y.4    Cooper, L.A.5    Subbarao, K.6
  • 12
    • 35348960407 scopus 로고    scopus 로고
    • Vaxfectin-formulated influenza DNA vaccines encoding NP and M2 viral proteins protect mice against lethal viral challenge
    • Jimenez G.S., Planchon R., Wei Q., Rusalov D., Geall A., Enas J., et al. Vaxfectin-formulated influenza DNA vaccines encoding NP and M2 viral proteins protect mice against lethal viral challenge. Hum Vaccin 3 (2007) 157-164
    • (2007) Hum Vaccin , vol.3 , pp. 157-164
    • Jimenez, G.S.1    Planchon, R.2    Wei, Q.3    Rusalov, D.4    Geall, A.5    Enas, J.6
  • 13
    • 46349102241 scopus 로고    scopus 로고
    • Plasmid DNA-based vaccines protect mice and ferrets against lethal challenge with A/Vietnam/1203/04 (H5N1) influenza virus
    • Lalor P.A., Webby R.J., Morrow J., Rusalov D., Kaslow D.C., Rolland A., et al. Plasmid DNA-based vaccines protect mice and ferrets against lethal challenge with A/Vietnam/1203/04 (H5N1) influenza virus. J Infect Dis 197 (2008) 1643-1652
    • (2008) J Infect Dis , vol.197 , pp. 1643-1652
    • Lalor, P.A.1    Webby, R.J.2    Morrow, J.3    Rusalov, D.4    Kaslow, D.C.5    Rolland, A.6
  • 14
    • 0032874490 scopus 로고    scopus 로고
    • A universal influenza A vaccine based on the extracellular domain of the M2 protein
    • Neirynck S., Deroo T., Saelens X., Vanlandschoot P., Jou W.M., and Fiers W. A universal influenza A vaccine based on the extracellular domain of the M2 protein. Nat Med 5 (1999) 1157-1163
    • (1999) Nat Med , vol.5 , pp. 1157-1163
    • Neirynck, S.1    Deroo, T.2    Saelens, X.3    Vanlandschoot, P.4    Jou, W.M.5    Fiers, W.6
  • 15
    • 0027411456 scopus 로고
    • Heterologous protection against influenza by injection of DNA encoding a viral protein
    • Ulmer J.B., Donnelly J.J., Parker S.E., Rhodes G.H., Felgner P.L., Dwarki V.J., et al. Heterologous protection against influenza by injection of DNA encoding a viral protein. Science 259 (1993) 1745-1749
    • (1993) Science , vol.259 , pp. 1745-1749
    • Ulmer, J.B.1    Donnelly, J.J.2    Parker, S.E.3    Rhodes, G.H.4    Felgner, P.L.5    Dwarki, V.J.6
  • 16
    • 0035961553 scopus 로고    scopus 로고
    • Vaxfectin enhances the humoral immune response to plasmid DNA-encoded antigens
    • Hartikka J., Bozoukova V., Ferrari M., Sukhu L., Enas J., Sawdey M., et al. Vaxfectin enhances the humoral immune response to plasmid DNA-encoded antigens. Vaccine 19 (2001) 1911-1923
    • (2001) Vaccine , vol.19 , pp. 1911-1923
    • Hartikka, J.1    Bozoukova, V.2    Ferrari, M.3    Sukhu, L.4    Enas, J.5    Sawdey, M.6
  • 17
    • 0035859294 scopus 로고    scopus 로고
    • Vaxfectin enhances antigen specific antibody titers and maintains Th1 type immune responses to plasmid DNA immunization
    • Reyes L., Hartikka J., Bozoukova V., Sukhu L., Nishioka W., Singh G., et al. Vaxfectin enhances antigen specific antibody titers and maintains Th1 type immune responses to plasmid DNA immunization. Vaccine 19 (2001) 3778-3786
    • (2001) Vaccine , vol.19 , pp. 3778-3786
    • Reyes, L.1    Hartikka, J.2    Bozoukova, V.3    Sukhu, L.4    Nishioka, W.5    Singh, G.6
  • 18
    • 39049175106 scopus 로고    scopus 로고
    • General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP)
    • Kroger A.T., Atkinson W.L., Marcuse E.K., and Pickering L.K. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 55 (2006) 1-48
    • (2006) MMWR Recomm Rep , vol.55 , pp. 1-48
    • Kroger, A.T.1    Atkinson, W.L.2    Marcuse, E.K.3    Pickering, L.K.4
  • 19
    • 2442599892 scopus 로고    scopus 로고
    • Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine
    • Stephenson I., Wood J.M., Nicholson K.G., Charlett A., and Zambon M.C. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine. Virus Res 103 (2004) 91-95
    • (2004) Virus Res , vol.103 , pp. 91-95
    • Stephenson, I.1    Wood, J.M.2    Nicholson, K.G.3    Charlett, A.4    Zambon, M.C.5
  • 20
    • 0033041241 scopus 로고    scopus 로고
    • Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays
    • Rowe T., Abernathy R.A., Hu-Primmer J., Thompson W.W., Lu X., Lim W., et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 37 (1999) 937-943
    • (1999) J Clin Microbiol , vol.37 , pp. 937-943
    • Rowe, T.1    Abernathy, R.A.2    Hu-Primmer, J.3    Thompson, W.W.4    Lu, X.5    Lim, W.6
  • 21
    • 46349108117 scopus 로고    scopus 로고
    • Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects
    • Wloch M.K., Smith L.R., Boutsaboualoy S., Reyes L., Han C., Kehler J., et al. Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects. J Infect Dis 197 (2008) 1634-1642
    • (2008) J Infect Dis , vol.197 , pp. 1634-1642
    • Wloch, M.K.1    Smith, L.R.2    Boutsaboualoy, S.3    Reyes, L.4    Han, C.5    Kehler, J.6
  • 22
    • 55849125109 scopus 로고    scopus 로고
    • Memory T cells established by seasonal human influenza A infection cross-react with avian influenza A (H5N1) in healthy individuals
    • Lee L.Y., Ha do L.A., Simmons C., de Jong M., Vinh Chau N.V., Schumacher R., et al. Memory T cells established by seasonal human influenza A infection cross-react with avian influenza A (H5N1) in healthy individuals. J Clin Invest 118 (2008) 3478-3490
    • (2008) J Clin Invest , vol.118 , pp. 3478-3490
    • Lee, L.Y.1    Ha do, L.A.2    Simmons, C.3    de Jong, M.4    Vinh Chau, N.V.5    Schumacher, R.6
  • 23
    • 43049117119 scopus 로고    scopus 로고
    • Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial
    • Rumke H.C., Bayas J.M., de Juanes J.R., Caso C., Richardus J.H., Campins M., et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 26 (2008) 2378-2388
    • (2008) Vaccine , vol.26 , pp. 2378-2388
    • Rumke, H.C.1    Bayas, J.M.2    de Juanes, J.R.3    Caso, C.4    Richardus, J.H.5    Campins, M.6
  • 25
    • 29744438219 scopus 로고    scopus 로고
    • Prior H1N1 influenza infection and susceptibility of Cleveland Family Study participants during the H2N2 pandemic of 1957: an experiment of nature
    • Epstein S.L. Prior H1N1 influenza infection and susceptibility of Cleveland Family Study participants during the H2N2 pandemic of 1957: an experiment of nature. J Infect Dis 193 (2006) 49-53
    • (2006) J Infect Dis , vol.193 , pp. 49-53
    • Epstein, S.L.1
  • 26
    • 67449168158 scopus 로고    scopus 로고
    • Implications of the emergence of a novel H1 influenza virus
    • Belshe R.B. Implications of the emergence of a novel H1 influenza virus. N Engl J Med 360 (2009) 2667-2668
    • (2009) N Engl J Med , vol.360 , pp. 2667-2668
    • Belshe, R.B.1
  • 27
    • 0037402228 scopus 로고    scopus 로고
    • The annual production cycle for influenza vaccine
    • Gerdil C. The annual production cycle for influenza vaccine. Vaccine 21 (2003) 1776-1779
    • (2003) Vaccine , vol.21 , pp. 1776-1779
    • Gerdil, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.