메뉴 건너뛰기




Volumn 201, Issue 11, 2010, Pages 1644-1653

Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: A randomized controlled phase 1/2 trial in adults

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; INFLUENZA VIRUS A H5N1 VACCINE; TOCOPHEROL; UNCLASSIFIED DRUG; VIRUS HEMAGGLUTININ;

EID: 77951883155     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/652701     Document Type: Article
Times cited : (81)

References (31)
  • 1
    • 67249138142 scopus 로고    scopus 로고
    • Pandemic potential of a strain of influenza A (H1N1): Early findings
    • Fraser C, Donnelly CA, Cauchemez S, et al. Pandemic potential of a strain of influenza A (H1N1): early findings. Science 2009; 324: 1557-1561
    • (2009) Science , vol.324 , pp. 1557-1561
    • Fraser, C.1    Donnelly, C.A.2    Cauchemez, S.3
  • 4
    • 52049100400 scopus 로고    scopus 로고
    • Stockpiling prepandemic influenza vaccines: A new cornerstone of pandemic preparedness plans
    • Jennings LC, Monto AS, Chan PK, Szucs TD, Nicholson KG. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect Dis 2008; 8: 650-658
    • (2008) Lancet Infect Dis , vol.8 , pp. 650-658
    • Jennings, L.C.1    Monto, A.S.2    Chan, P.K.3    Szucs, T.D.4    Nicholson, K.G.5
  • 6
    • 67650660154 scopus 로고    scopus 로고
    • Options for the use of human H5N1 influenza vaccines and the WHO H5N1 stockpile
    • World Health Organization (WHO). October 1-3, 2007 Geneva: WHO
    • World Health Organization (WHO). Options for the use of human H5N1 influenza vaccines and the WHO H5N1 stockpile. WHO scientific consultation October 1-3, 2007. Geneva: WHO, 2007.
    • (2007) WHO Scientific Consultation
  • 7
    • 33645399959 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine
    • Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006; 354: 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
  • 8
    • 33846703808 scopus 로고    scopus 로고
    • Mass vaccination for annual and pandemic influenza
    • Schwartz B, Wortley P. Mass vaccination for annual and pandemic influenza. Curr Top Microbiol Immunol 2006; 304: 131-152
    • (2006) Curr Top Microbiol Immunol , vol.304 , pp. 131-152
    • Schwartz, B.1    Wortley, P.2
  • 10
    • 33646549355 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: Phase 1 randomised trial
    • Bresson JL, Perronne C, Launay O, et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase 1 randomised trial. Lancet 2006; 367: 1657-1664
    • (2006) Lancet , vol.367 , pp. 1657-1664
    • Bresson, J.L.1    Perronne, C.2    Launay, O.3
  • 12
    • 0035897889 scopus 로고    scopus 로고
    • 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
    • Nicholson KG, Colegate AE, Podda A, et al. 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 2001; 357: 1937-2013
    • (2001) Lancet , vol.357 , pp. 1937-2013
    • Nicholson, K.G.1    Colegate, A.E.2    Podda, A.3
  • 14
    • 34250011726 scopus 로고    scopus 로고
    • Pre- Or post-pandemic influenza vaccine?
    • Osterhaus AD. Pre- or post-pandemic influenza vaccine? Vaccine 2007; 25: 4983-4991
    • (2007) Vaccine , vol.25 , pp. 4983-4991
    • Osterhaus, A.D.1
  • 15
    • 40549088240 scopus 로고    scopus 로고
    • Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults
    • Bernstein DI, Edwards KM, Dekker CL, 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
  • 16
  • 17
    • 43049097919 scopus 로고    scopus 로고
    • Broad clade 2 cross-reactive immunity induced by an adju-vanted clade 1 rH5N1 pandemic influenza vaccine
    • Leroux-Roels I, Bernhard R, Gérard P, Dramé M, Hanon E, LerouxRoels G. Broad clade 2 cross-reactive immunity induced by an adju-vanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One 2008; 3:e1665.
    • (2008) PloS One , vol.3
    • Leroux-Roels, I.1    Bernhard, R.2    Gérard, P.3    Dramé, M.4    Hanon, E.5    Lerouxroels, G.6
  • 18
    • 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, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370: 580-589
    • (2007) Lancet , vol.370 , pp. 580-589
    • Leroux-Roels, I.1    Borkowski, A.2    Vanwolleghem, T.3
  • 20
    • 67650670745 scopus 로고    scopus 로고
    • Prepandemic H5N1 influenza vaccine adjuvanted with AS03: A review of the pre-clinical and clinical data
    • Leroux-Roels G. Prepandemic H5N1 influenza vaccine adjuvanted with AS03: a review of the pre-clinical and clinical data. Expert Opin Biol Ther 2009; 9: 1057-1071
    • (2009) Expert Opin Biol Ther , vol.9 , pp. 1057-1071
    • Leroux-Roels, G.1
  • 21
    • 2442597735 scopus 로고    scopus 로고
    • Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use
    • Hehme N, Engelmann H, Kuenzel W, Neumeier E, Saenger R. Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use. Virus Res 2004; 103: 163-171
    • (2004) Virus Res , vol.103 , pp. 163-171
    • Hehme, N.1    Engelmann, H.2    Kuenzel, W.3    Neumeier, E.4    Saenger, R.5
  • 22
    • 0003640344 scopus 로고
    • Hemagglutination inhibition
    • Kendal AP, Pereira MS, Skehel JJ, eds. Atlanta: Centers for Disease Control and Prevention and Pan-American Health Organization
    • Kendal AP, Pereira MS, Skehel JJ. Hemagglutination inhibition. In: Kendal AP, Pereira MS, Skehel JJ, eds. Concepts and procedures for laboratory-based influenza surveillance. Atlanta: Centers for Disease Control and Prevention and Pan-American Health Organization 1982: B17-35.
    • (1982) Concepts and Procedures for Laboratory-based Influenza Surveillance
    • Kendal, A.P.1    Pereira, M.S.2    Skehel, J.J.3
  • 23
    • 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 RA, Hu-Primmer J, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999; 37: 937-943
    • (1999) J Clin Microbiol , vol.37 , pp. 937-943
    • Rowe, T.1    Abernathy, R.A.2    Hu-Primmer, J.3
  • 24
    • 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 JM, Nicholson KG, Charlett A, Zambon MC. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine. Virus Res 2004; 103: 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
  • 25
    • 34548211557 scopus 로고    scopus 로고
    • Food and drug administration, US department of health and human services
    • Center for Biologics Evaluation and Research, Rockville, MD: Food and Drug Administration, May
    • Center for Biologics Evaluation and Research, Food and Drug Administration, US Department of Health and Human Services. Guidance for industry: clinical data needed to support the licensure of pandemic influenza vaccines. Rockville, MD: Food and Drug Administration, May 2007.
    • (2007) Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
  • 26
    • 33745158157 scopus 로고
    • A simple method of estimating fifty percent endpoints
    • Reed L, Muench H. A simple method of estimating fifty percent endpoints. Am J Hyg 1938; 27: 493-497
    • (1938) Am J Hyg , vol.27 , pp. 493-497
    • Reed, L.1    Muench, H.2
  • 28
    • 33645802797 scopus 로고    scopus 로고
    • Mitigation strategies for pandemic influenza in the United States
    • Germann TC, Kadau K, Longini IM Jr, Macken CA. Mitigation strategies for pandemic influenza in the United States. Proc Natl Acad Sci U S A 2006; 103: 5935-5940
    • (2006) Proc Natl Acad Sci U S A , vol.103 , pp. 5935-5940
    • Germann, T.C.1    Kadau, K.2    Jr, L.I.M.3    Macken, C.A.4
  • 29
    • 33748447102 scopus 로고    scopus 로고
    • Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: A phase i randomised controlled trial
    • Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006; 368: 991-997
    • (2006) Lancet , vol.368 , pp. 991-997
    • Lin, J.1    Zhang, J.2    Dong, X.3
  • 30
    • 43049117119 scopus 로고    scopus 로고
    • Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial
    • Rümke HC, Bayas JM, de Juanes JR, et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 2008; 26: 2378-2388
    • (2008) Vaccine , vol.26 , pp. 2378-2388
    • Rümke, H.C.1    Bayas, J.M.2    De Juanes, J.R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.