Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania: Preclinical evaluation of split virion inactivated H5N1 vaccine with adjuvant

References

• Kieny MP. Global action plan for influenza vaccines: what still needs to be done? Seventh Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers; Dubai, UAE, 25 March 2014, www.who.int/phi/DAY1_01_Kieny_PM_Dubai2014.pdf
   Google Scholar
• Fox CB, Huynh C, O'Hara MK, Onu A. Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania. Vaccine 2013; 31:1633-40; PMID:23103197; http://dx.doi.org/10.1016/j.vaccine.2012.10.048
   PubMed Web of Science ®Google Scholar
• Baudner BC, Ronconi V, Casini D, Tortoli M, Kazzaz J, Singh M, Hawkins LD, Wack A, O'Hagan DT. MF59 emulsion is an effective delivery system for a synthetic TLR4 agonist (E6020). Pharm Res 2009; 26:1477-85; PMID:19255727; http://dx.doi.org/10.1007/s11095-009-9859-5
   PubMed Web of Science ®Google Scholar
• O'Hagan DT, Ott GS, Van Nest G, Rappuoli R, Giudice GD. The history of MF59 adjuvant: a phoenix that arose from the ashes. Exp Rev Vaccines 2013; 12:13-30; PMID:23256736; http://dx.doi.org/10.1586/erv.12.140
   PubMed Web of Science ®Google Scholar
• O'Hagan DT, Singh M. MF59: a safe and potent oil-in-water emulsion adjuvant. In: Singh M, editor. Vaccine Adjuvants and Delivery Systems. Hoboken, NJ: John Wiley & Sons; 2007. p. 115-29.
   Google Scholar
• Fox CB, Barnes VL, Evers T, Chesko JD, Vedvick TS, Coler RN, Reed SG, Baldwin SL. Adjuvanted pandemic influenza vaccine: variation of emulsion components affects stability, antigen structure, and vaccine efficacy. Influenza Other Respi Viruses 2013; 7:815-26; PMID:23122325; http://dx.doi.org/10.1111/irv.12031
   PubMed Web of Science ®Google Scholar
• Smith H, Sweet C. Lessons for human influenza from pathogenicity studies with ferrets. Rev Infect Dis 1988; 10:56-75; PMID:3281223; http://dx.doi.org/10.1093/clinids/10.1.56
   PubMedGoogle Scholar
• Ibricevic A, Pekosz A, Walter MJ, Newby C, Battaile JT, Brown EG, Holtzman MJ, Brody SL. Influenza virus receptor specificity and cell tropism in mouse and human airway epithelial cells. J Virol 2006; 80:7469-80; PMID:16840327; http://dx.doi.org/10.1128/JVI.02677-05
   PubMed Web of Science ®Google Scholar
• Maher JA, DeStefano J. The ferret: an animal model to study influenza virus. Lab Anim 2004; 33:50-3; PMID:15457202; http://dx.doi.org/10.1038/laban1004-50
   PubMed Web of Science ®Google Scholar
• Tanaka H, Park CH, Ninomiya A, Ozaki H, Takada A, Umemura T, Kida H. Neurotropism of the Hong Kong H5N1 influenza virus in mice. Vet Microbiol 1997; 95:1-13; PMID:12860072; http://dx.doi.org/10.1016/S0378-1135(03)00132-9
   PubMed Web of Science ®Google Scholar
• van Riel D, Munster VJ, de Wit E, Rimmelzwaan GF, Fouchier RAM, Osterhaus AD, Kuiken T. Virus attachment to lower respiratory tract. Science 2006; 312:399; PMID:16556800; http://dx.doi.org/10.1126/science.1125548
   PubMed Web of Science ®Google Scholar
• van Riel D, den Bakker MA, Leijten LME, Chutinimitkul S, Munster VJ, de Wit E, Rimmelzwaan GF, Fouchier RAM, Osterhaus ADME, Kuiken T. Seasonal and pandemic human influenza viruses attach better to human upper respiratory tract epithelium than avian influenza viruses. Am J Pathol 176(4):1614-8; PMID:20167867; http://dx.doi.org/10.2353/ajpath.2010.090949
   PubMed Web of Science ®Google Scholar
• Jackson LA, Campbell JD, Frey SE, Edwards KM, Keitel WA, Kotloff KL, Berry AA, Graham I, Atmar RL, Creech CB, et al. Effect of varying doses of a monovalent h7n9 influenza vaccine with and without as03 and mf59 adjuvants on immune response: A randomized clinical trial. JAMA 2015; 314(3):237-46; PMID:26197184; http://dx.doi.org/10.1001/jama.2015.7916
   PubMed Web of Science ®Google Scholar
• Hamidi A, Boog C, Jadhav S, Kreeftenberg H. Lessons learned during the development and transfer of technology related to a new Hib conjugate vaccine to emerging vaccine manufacturers. Vaccine 2014; 32(33):4124-30; PMID:24923635; http://dx.doi.org/10.1016/j.vaccine.2014.05.023
   PubMed Web of Science ®Google Scholar
• Ventura R, Brunner L, Heriyanto B, de Boer O, O'Hara M, Huynh C, Suhardono M, Collin N. Technology transfer of an oil-in-water vaccine-adjuvant for strengthening pandemic influenza preparedness in Indonesia. Vaccine 2013; 31(12):1641-5; PMID:22884665; http://dx.doi.org/10.1016/j.vaccine.2012.07.074
   PubMed Web of Science ®Google Scholar
• Crager SE. Improving global access to new vaccines: intellectual property, technology transfer, and regulatory pathways. Am J Public Health 2014; 104(11):e85-e91; PMID:25211753; http://dx.doi.org/10.2105/AJPH.2014.302236
   PubMed Web of Science ®Google Scholar
• Stephenson I, Wood JM, Nicholson KG, Zambon MC. Sialic acid receptor specificity on erythrocytes affects detection of antibody to avian influenza haemagglutinin. J Med Virol 2003; 70(3):391-8; PMID:12767002; http://dx.doi.org/10.1002/jmv.10408
   PubMed Web of Science ®Google Scholar
• 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(8):1057-71; PMID:19555313; http://dx.doi.org/10.1517/14712590903066695
   PubMed Web of Science ®Google Scholar
• Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. New Eng J Med 2006; 354:1343-51; PMID:16571878; http://dx.doi.org/10.1056/NEJMoa055778
   PubMed Web of Science ®Google Scholar
• Layton RC, Petrovsky N, Gigliotti AP, Pollock Z, Knight J, Donart N, Pyles J, Harrod KS, Gao P, Koster F. Delta inulin polysaccharide adjuvant enhances the ability of split-virion H5N1 vaccine to protect against lethal challenge in ferrets. Vaccine 2011; 29(37):6242-51; PMID:21736913; http://dx.doi.org/10.1016/j.vaccine.2011.06.078
   PubMed Web of Science ®Google Scholar
• Middleton D, Rockman S, Pearse M, Barr I, Lowther S, Klippel J, Ryan D, Brown L. Evaluation of vaccines for H5N1 influenza virus in ferrets reveals the potential for protective single-shot immunization. J Virol 2009; 83:7770-8; PMID:19457991; http://dx.doi.org/10.1128/JVI.00241-09
   PubMed Web of Science ®Google Scholar
• Cox R. Correlates of protection to influenza virus, where do we go from here? Hum Vaccines Immunother 2013; 9(2):405-8; PMID:23291930
   PubMed Web of Science ®Google Scholar
• DiLillo DJ, Tan GS, Palese P, Ravetch JV. Broadly neutralizing hemagglutinin stalk-specific antibodies require Fc[gamma]R interactions for protection against influenza virus in vivo. Nat Med 2014; 20(2):143-51; PMID:24412922; http://dx.doi.org/10.1038/nm.3443
   PubMed Web of Science ®Google Scholar
• Bodewes R, Kreijtz JH, Van Amerongen G, Fouchier RA, Osterhaus AD, Rimmelzwaan G, Kuiken T. Pathogenesis of influenza A/H5N1 virus infection in ferrets differs between intransal and intratracheal routes of inoculation. Am J Path 2011; 179:30-6; PMID:21640972; http://dx.doi.org/10.1016/j.ajpath.2011.03.026
   PubMed Web of Science ®Google Scholar
• Park CH, Ishinaka M, Takada A, Kida H, Kimura T, Ochiai K, Umemura T. The invasion routes of neurovirulent A/Hong Kong/483/97 (H5N1) influenza virus into the central nervous system after respiratory infection in mice. Arch Virol 2002; 147:1425-36; PMID:12111416; http://dx.doi.org/10.1007/s00705-001-0750-x
   PubMed Web of Science ®Google Scholar
• Reed LJ, Muench H. A simple method of estimating fifty per cent endpoints. Am J Epidemiol 1938; 27(3):493-7
   Google Scholar
• R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2014 [updated 2014; cited]; Available from: https://www.R-project.org.
   Google Scholar
• Haaland P, Samarov D, McVey E. calibFit: Statistical models and tools for assay calibration. R package version 2.1.0. 2011 https://CRAN.R-project.org/package=calibFit.
   Google Scholar
• Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods 2012; 9:671-5; PMID:22930834; http://dx.doi.org/10.1038/nmeth.2089
   PubMed Web of Science ®Google Scholar
• Clegg CH, Roque R, Perrone LA, Rininger JA, Bowen R, Reed SG. GLA-AF, an emulsion-free vaccine adjuvant for pandemic influenza. PLoS One 2014; 9(2):e88979; PMID:24551202; http://dx.doi.org/10.1371/journal.pone.0088979
   PubMed Web of Science ®Google Scholar