Prepandemic H5N1 influenza vaccine adjuvanted with AS03: a review of the pre-clinical and clinical data

Bibliography

• H5N1 avian influenza – first steps towards development of a human vaccine. WHO, 2005; Available from: http://www.who. int/csr/disease/avian_influenza/statement_2005_08_12/en/index.html [Last accessed 10 June 2009]
   Google Scholar
• Cox NJ, Fukuda K. Influenza. Infect Dis Clin North Am 1998;12(1):27-38
   PubMed Web of Science ®Google Scholar
• Webster RG, Bean WJ, Gorman OT, et al. Evolution and ecology of influenza A viruses. Microbiol Rev 1992;56(1):152-79
   PubMedGoogle Scholar
• Fouchier RA, Munster V, Wallensten A, et al. Characterization of a novel influenza A virus hemagglutinin subtype (H16) obtained from black-headed gulls. J Virol 2005;79(5):2814-22
   PubMed Web of Science ®Google Scholar
• Cox NJ, Subbarao K. Global epidemiology of influenza: past and present. Annu Rev Med 2000;51:407-21
   PubMed Web of Science ®Google Scholar
• Salomon R, Franks J, Govorkova EA, et al. The polymerase complex genes contribute to the high virulence of the human H5N1 influenza virus isolate A/Vietnam/1203/04. J Exp Med 2006;203(3):689-97
   PubMed Web of Science ®Google Scholar
• Taubenberger JK, Reid AH, Lourens RM, et al. Characterization of the 1918 influenza virus polymerase genes. Nature 2005;437(7060):889-93
   PubMed Web of Science ®Google Scholar
• Matrosovich MN, Matrosovich TY, Gray T, et al. Human and avian influenza viruses target different cell types in cultures of human airway epithelium. Proc Natl Acad Sci USA 2004;101(13):4620-4
   PubMed Web of Science ®Google Scholar
• Connor RJ, Kawaoka Y, Webster RG, Paulson JC. Receptor specificity in human, avian, and equine H2 and H3 influenza virus isolates. Virology 1994;205(1):17-23
   PubMed Web of Science ®Google Scholar
• Glaser L, Stevens J, Zamarin D, et al. A single amino acid substitution in 1918 influenza virus hemagglutinin changes receptor binding specificity. J Virol 2005;79(17):11533-6
   PubMed Web of Science ®Google Scholar
• Nicholson KG, Wood JM, Zambon M. Influenza. Lancet 2003;362(9397):1733-45
   PubMed Web of Science ®Google Scholar
• Peiris JS, de Jong MD, Guan Y. Avian influenza virus (H5N1): a threat to human health. Clin Microbiol Rev 2007;20(2):243-67
   PubMed Web of Science ®Google Scholar
• Beigel JH, Farrar J, Han AM, et al. Avian influenza A (H5N1) infection in humans. N Engl J Med 2005;353(13):1374-85
   PubMed Web of Science ®Google Scholar
• Tran TH, Nguyen TL, Nguyen TD, et al. Avian influenza A (H5N1) in 10 patients in Vietnam. N Engl J Med 2004;350(12):1179-88
   PubMed Web of Science ®Google Scholar
• Yuen KY, Chan PK, Peiris M, et al. Clinical features and rapid viral diagnosis of human disease associated with avian influenza A H5N1 virus. Lancet 1998;351(9101):467-71
   PubMed Web of Science ®Google Scholar
• de Jong MD, Simmons CP, Thanh TT, et al. Fatal outcome of human influenza A (H5N1) is associated with high viral load and hypercytokinemia. Nat Med 2006;12(10):1203-7
   PubMed Web of Science ®Google Scholar
• WHO. Options for the use of human H5N1 influenza vaccines and the WHO H5N1 vaccine stockpile; WHO, 2007. Available from: http://www.who.int/csr/resources/publications/WHO_HSE_ EPR_GIP_2008_1d.pdf [Last accessed 10 June 2009]
   Google Scholar
• Jennings LC, Monto AS, Chan PK, et al. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect Dis 2008;8(10):650-8
   PubMed Web of Science ®Google Scholar
• Leroux-Roels I, Leroux-Roels G. Current status and progress of prepandemic and pandemic influenza vaccine development. Expert Rev Vaccines 2009;8(4):401-23
   PubMed Web of Science ®Google Scholar
• Wood JM, Robertson JS. From lethal virus to life-saving vaccine: developing inactivated vaccines for pandemic influenza. Nat Rev Microbiol 2004;2(10):842-7
   PubMed Web of Science ®Google Scholar
• Prepandrix suspension and emulsion for injection. European prescribing information (on line). Rixensart, Belgium; GlaxoSmithKline Biologicals 2008. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/ prepandrix/H-822-PI-en.pdf [Last accessed 10 June 2009]
   Google Scholar
• Li Y, Svehla K, Mathy NL, et al. Characterization of antibody responses elicited by human immunodeficiency virus type 1 primary isolate trimeric and monomeric envelope glycoproteins in selected adjuvants. J Virol 2006;80(3):1414-26
   PubMed Web of Science ®Google Scholar
• Potter CW, Oxford JS. Determinants of immunity to influenza infection in man. Br Med Bull 1979;35(1):69-75
   PubMed Web of Science ®Google Scholar
• Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (Revision). (EMEA/CPMP/VEG/4717/2003 - Rev.1). London UK: European Medicines Agency, 2008. Available from: http://www.emea.europa.eu/pdfs/human/vwp/471703enfin.pdf [Last accessed 10 June 2009]
   Google Scholar
• Guidance for Industry. Clinical data needed to support the licensure of pandemic influenza vaccines. 2007. Rockville, MD: US FDA.: 2009. Available from: http://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/Vaccines/ ucm074786.htm [Last accessed 10 June 2009]
   Google Scholar
• 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(9587):580-9
   PubMed Web of Science ®Google Scholar
• Chu D-S, Dramé M, Hwang S-J. Safety and immunogenicity of an AS adjuvanted H5N1 pepandemic influenza vaccine: a Phase III study in a large population of Asian adults [abstract]. 10th International Symposium on Respiratory Viral Infections; Singapore, 28 February – 2 March 2008
   Google Scholar
• Rumke 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(19):2378-88
   PubMed Web of Science ®Google Scholar
• Heijmans S, De Meulemeester M, Reynders P. AS03-adjuvanted prepandemic influenza vaccine: high immunogenicity in elderly [abstract]. 2nd Vaccine Congress; Boston, MA, USA, 7 – 9 December 2008
   Google Scholar
• Leroux-Roels I, Bernhard R, Gerard P, et al. Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS ONE 2008;3(2):e1665. Published online 27 February 2008, doi:10.1371/journal.pone.0001665
   PubMed Web of Science ®Google Scholar
• Moris P, Leroux-Roels I, Dramé M, et al. Heterologous cell-mediated immunity priming using adjuvanted H5N1 vaccine. 9th International Symposium on Respiratory Viral Infections; Hong Kong, 3 – 6 March 2007
   Google Scholar
• Leroux-Roels I, Moris P, Dramé M, et al. Persistent immune response against clade 1 and 2 H5N1 strains induced by an AS adjuvanted H5N1 clade 1 candidate prepandemic influenza vaccine. International Conference on Avian Influenza; Bangkok, 23 – 25 January 2008
   Google Scholar
• Jilg W, Schwarz TF, Horacek T. AS03-adjuvanted prepandemic H5N1 vaccine: a single dose primary vaccination with clade 1 vaccine strain leads to strong immune responsiveness to clade 2 strain booster vaccination [abstract]. The third European Influenza Conference 2008 14-17 September; Villamoura, Portugal; 2008
   Google Scholar
• Schwarz TF, Horacek T, Knuf M. AS03-adjuvanted prepandemic H5N1 vaccine allows highly flexible prime-boost vaccination strategy [abstract]. The third European Influenza Conference; 2008 14-17 September; Villamoura, Portugal; 2008
   Google Scholar
• Govorkova EA, Rehg JE, Krauss S, et al. Lethality to ferrets of H5N1 influenza viruses isolated from humans and poultry in 2004. J Virol 2005;79(4):2191-8
   PubMed Web of Science ®Google Scholar
• Hampson AW. Ferrets and the challenges of H5N1 vaccine formulation. J Infect Dis 2006;194(2):143-5
   PubMed Web of Science ®Google Scholar
• Zitzow LA, Rowe T, Morken T, et al. Pathogenesis of avian influenza A (H5N1) viruses in ferrets. J Virol 2002;76(9):4420-9
   PubMed Web of Science ®Google Scholar
• Baras B, Stittelaar K, Jh S. Immunization with low dose adjuvanted split H5N1 pandemic vaccine protects ferrets against homologous challenge [abstract]. IXth International Symposium on Respiratory Viral Infections; 2007 3-6 March; Hong Kong; 2007
   Google Scholar
• Baras B, Stittelaar KJ, Simon JH, et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008;3(1):e1401. Published online 2 January 2008, doi:10.1371/journal.pone.0001401
   PubMed Web of Science ®Google Scholar
• Ballester A, Garcés-Sanches M, Planelles Cantinaro M. Pediatric safety evaluation of an AS-adjuvanted H5N1 prepandemic candidate vaccine in children aged 6-9 years. A phase II study [abstract]. Annual Meeting of the European Society for Pediatric Infectious Diseases; 2008 13-17 May; Graz, Austria; 2008
   Google Scholar
• Ballester A, Garcés-Sanches M, Planelles Cantinaro M, et al. Pediatric safety evalation of an AS-adjuvanted H5N1 prepandemic candidate vaccine in children aged 3-9 years. A phase II study [abstract]. 13th International Congress of Infectious Diseases; 2008 June 19-22; Kuala Lumpur, Malaysia; 2008
   Google Scholar