Safety and immunogenicity of influenza whole inactivated virus vaccines: A phase I randomized clinical trial

References

• Monto AS. Influenza: quantifying morbidity and mortality. Am J Med 1987; 82:20-5; PMID:3591814; http://dx.doi.org/10.1016/0002-9343(87)90556-0
   PubMedGoogle Scholar
• Palese P, Garcia-Sastre A. Influenza vaccines: present and future. J Clin Invest 2002; 110:9-13; PMID:12093881; http://dx.doi.org/10.1172/JCI0215999
   PubMed Web of Science ®Google Scholar
• Poland GA, Ovsyannikova IG, Jacobson RM. Immunogenetics of seasonal influenza vaccine response. Vaccine 2008; 26:D35-40; PMID:19230157; http://dx.doi.org/10.1016/j.vaccine.2008.07.065
   PubMed Web of Science ®Google Scholar
• Nichol KL. Efficacy and effectiveness of influenza vaccination. Vaccine 2008; 26:D17-22; PMID:19230153; http://dx.doi.org/10.1016/j.vaccine.2008.07.048
   PubMed Web of Science ®Google Scholar
• Oshitani H, Kamigaki T, Suzuki A. Major issues and challenges of influenza pandemic preparedness in developing countries. Emerg Infect Dis 2008; 14:875-80; PMID:18507896; http://dx.doi.org/10.3201/eid1406.070839
   PubMed Web of Science ®Google Scholar
• World Health Organization. Pandemic preparedness and response. WHO Guidance document 2009. [Last viewed on March 10, 2015] Available at http://www.who.int/influenza/resources/documents/pandemic_guidance_04_2009/en/  
   Google Scholar
• Kieny MP, Costa A, Hombach J, Carrasco P, Pervikov Y, Salisbury D, Greco M, Gust I, LaForce M, Franco-Paredes C, et al. A global pandemic influenza vaccine action plan. Vaccine 2006; 24:6367-70; PMID:17240560; http://dx.doi.org/10.1016/j.vaccine.2006.07.021
   PubMed Web of Science ®Google Scholar
• World Health Organization. Global pandemic influenza action plan to increase vaccine supply. 2006. [Last viewed on march 10, 2015] Available at http://www.who.int/csr/resources/publications/influenza/WHO_CDS_EPR_GIP_2006_1/en/
   Google Scholar
• World Health Organization. Pandemic influenza vaccines: current status. Pandemic (H1N1) 2009 11. 2009
   Google Scholar
• Jadhav S, Datla M, Kreeftenberg H, Hendriks J. The developing countries vaccine manufacturers' network (DCVMN) is a critical constituency to ensure access to vaccines in developing countries. Vaccine 2008; 26:1611-5; PMID:18294742; http://dx.doi.org/10.1016/j.vaccine.2008.01.034
   PubMed Web of Science ®Google Scholar
• Hendriks J, Holleman M, de Boer O, de Jong P, Luytjes W. An international technology platform for influenza vaccines. Vaccine 2011; 29 1:A8-11; PMID:21684431; http://dx.doi.org/10.1016/j.vaccine.2011.04.124
   PubMedGoogle Scholar
• World Health Organization. Recommendations for the production and control of influenza vaccine (inactivated). WHO Tech Rep Series, No. 927, 2005, 3. 2005
   Google Scholar
• Stephenson I, Nicholson KG, Gluck R, Mischler R, Newman RW, Palache AM, Verlander NQ, Warburton F, Wood JM, Zambon MC. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 2003; 362:1959-66; PMID:14683655; http://dx.doi.org/10.1016/S0140-6736(03)15014-3
   PubMed Web of Science ®Google Scholar
• Parkman PD, Hopps HE, Rastogi SC, Meyer HM, Jr. Summary of clinical trials of influenza virus vaccines in adults. J Infect Dis 1977; 136 S722-30; PMID:606797; http://dx.doi.org/10.1093/infdis/136.Supplement_3.S722
   PubMed Web of Science ®Google Scholar
• Beyer WE, Palache AM, Osterhaus AD. Comparison of serology and reactogenicity between influenza subunit vaccines and whole virus or split vaccines: a review and meta-analysis of the literature. Clin Drug Invest 1998; 15:1-12; PMID:18370460; http://dx.doi.org/10.2165/00044011-199815010-00001
   PubMed Web of Science ®Google Scholar
• Zabel F, Kundig TM, Bachmann MF. Virus-induced humoral immunity: on how B cell responses are initiated. Curr Opin Virol 2013; 3:357-62; PMID:23731601; http://dx.doi.org/10.1016/j.coviro.2013.05.004
   PubMed Web of Science ®Google Scholar
• Bachmann MF, Jennings GT. Vaccine delivery: a matter of size, geometry, kinetics and molecular patterns. Nat Rev Immunol 2010; 10:787-96; PMID:20948547; http://dx.doi.org/10.1038/nri2868
   PubMed Web of Science ®Google Scholar
• Geeraedts F, Bungener L, Pool J, ter Veer W, Wilschut J, Huckriede A. Whole inactivated virus influenza vaccine is superior to subunit vaccine in inducing immune responses and secretion of proinflammatory cytokines by DCs. Influenz Other Res Virus 2008; 2:41-51; PMID:19453471; http://dx.doi.org/10.1111/j.1750-2659.2008.00038.x
   PubMed Web of Science ®Google Scholar
• Geeraedts F, Goutagny N, Hornung V, Severa M, de Haan A, Pool J, Wilschut J, Fitzgerald KA, Huckriede A. Superior immunogenicity of inactivated whole virus H5N1 influenza vaccine is primarily controlled by Toll-like receptor signalling. PLoS Pathog 2008; 4:e1000138; PMID:18769719; http://dx.doi.org/10.1371/journal.ppat.1000138
   PubMed Web of Science ®Google Scholar
• Hovden AO, Cox RJ, Haaheim LR. Whole influenza virus vaccine is more immunogenic than split influenza virus vaccine and induces primarily an IgG2a response in BALB/c mice. Scandinavian j Immunol 2005; 62:36-44; PMID:16092921; http://dx.doi.org/10.1111/j.1365-3083.2005.01633.x
   PubMed Web of Science ®Google Scholar
• Budimir N, Huckriede A, Meijerhof T, Boon L, Gostick E, Price DA, Wilschut J, de Haan A. Induction of heterosubtypic cross-protection against influenza by a whole inactivated virus vaccine: the role of viral membrane fusion activity. PLoS One 2012; 7:e30898; PMID:22303469; http://dx.doi.org/10.1371/journal.pone.0030898
   PubMed Web of Science ®Google Scholar
• Beigel JH, Voell J, Huang CY, Burbelo PD, Lane HC. Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine. J Infect Dis 2009; 200:501-9; PMID:19569973; http://dx.doi.org/10.1086/599992
   PubMed Web of Science ®Google Scholar
• Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009; 361:2424-35; PMID:19745215; http://dx.doi.org/10.1056/NEJMoa0907650
   PubMed Web of Science ®Google Scholar
• Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, et al. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA 2010; 303:37-46; PMID:20026597; http://dx.doi.org/10.1001/jama.2009.1911
   PubMed Web of Science ®Google Scholar
• Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, 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; 375:41-8; PMID:20018365; http://dx.doi.org/10.1016/S0140-6736(09)62026-2
   PubMed Web of Science ®Google Scholar
• Bernstein DI, Edwards KM, Dekker CL, Belshe R, Talbot HK, Graham IL, Noah DL, He F, Hill H. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 2008; 197:667-75; PMID:18260764; http://dx.doi.org/10.1086/527489
   PubMed Web of Science ®Google Scholar
• Leroux-Roels I, Borkowski A, Vanwolleghem T, Drame M, Clement F, Hons E, Devaster JM, Leroux-Roels G. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370:580-9; PMID:17707753; http://dx.doi.org/10.1016/S0140-6736(07)61297-5
   PubMed Web of Science ®Google Scholar
• Soema PC, Rosendahl Huber SK, Willems GJ, Jiskoot W, Kersten GF, Amorij JP. Influenza T-cell Epitope-Loaded Virosomes Adjuvanted with CpG as a potential Influenza vaccine. Pharm Res 2014; PMID:25344321 Open Acess. Available at http://link.springer.com/article/10.1007/s11095-014-1556-3/fulltext.html
   PubMedGoogle Scholar
• Sansyzbay AR, Erofeeva MK, Khairullin BM, Sandybayev NT, Kydyrbayev ZK, Mamadaliyev SM, Kassenov MM, Sergeeva MV, Romanova JR, Krivitskaya VZ, et al. An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/chicken/astana/6/05) influenza vaccine is safe and immunogenic in a single dose in humans. Clin Vaccine Immunol 2013; 20:1314-9; PMID:23803900; http://dx.doi.org/10.1128/CVI.00096-13
   PubMed Web of Science ®Google Scholar
• Wu J, Fang HH, Chen JT, Zhou JC, Feng ZJ, Li CG, Qiu YZ, Liu Y, Lu M, Liu LY, et al. Immunogenicity, safety, and cross-reactivity of an inactivated, adjuvanted, prototype pandemic influenza (H5N1) vaccine: a phase II, double-blind, randomized trial. Clin Infect Dis 2009; 48:1087-95; PMID:19281330; http://dx.doi.org/10.1086/597401
   PubMed Web of Science ®Google Scholar
• Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006; 368:991-7; PMID:16980114; http://dx.doi.org/10.1016/S0140-6736(06)69294-5
   PubMed Web of Science ®Google Scholar
• Ikeno D, Kimachi K, Kino Y, Harada S, Yoshida K, Tochihara S, Itamura S, Odagiri T, Tashiro M, Okada K, et al. Immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1, NIBRG-14) vaccine administered by intramuscular or subcutaneous injection. Microbiol Immunol 2010; 54:81-8; PMID:20377741; http://dx.doi.org/10.1111/j.1348-0421.2009.00191.x
   PubMed Web of Science ®Google Scholar
• Beran J, Abdel-Messih IA, Raupachova J, Hobzova L, Fragapane E. A phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses. Clin Ther 2010; 32:2186-97; PMID:21316535; http://dx.doi.org/10.1016/S0149-2918(11)00024-5
   PubMed Web of Science ®Google Scholar
• Vesikari T, Forsten A, Herbinger KH, Cioppa GD, Beygo J, Borkowski A, Groth N, Bennati M, von Sonnenburg F. Safety and immunogenicity of an MF59((R))-adjuvanted A/H5N1 pre-pandemic influenza vaccine in adults and the elderly. Vaccine 2012; 30:1388-96; PMID:22192847; http://dx.doi.org/10.1016/j.vaccine.2011.12.009
   PubMed Web of Science ®Google Scholar
• van Els C, Mjaaland S, Naess L, Sarkadi J, Gonczol E, Smith Korsholm K, Hansen J, de Jonge J, Kersten G, Warner J, et al. Fast vaccine design and development based on correlates of protection (COPs): Influenza as a trendsetter. Hum Vaccin Immunother 2014; 10:1935-48; PMID:25424803; http://dx.doi.org/10.4161/hv.28639
   PubMedGoogle Scholar
• Reber A, Katz J. Immunological assessment of influenza vaccines and immune correlates of protection. Expert Rev Vaccines 2013; 12:519-36; PMID:23659300; http://dx.doi.org/10.1586/erv.13.35
   PubMed Web of Science ®Google Scholar
• World Health Organization. Guidelines on clinical evaluation of vaccines: regulatory expectations. WHO Tech Rep Ser No. 924, 2004, 1. 2004.
   Google Scholar
• Palmer D, Dowle, W., Coleman,M., and Schild, G. Haemagglutination inhibition test. Advanced laboratory techniques for influenza diagnosis: procedural guide. Atlanta, GA: US. Dep Health Edu Welfare 1975:25-62.
   Google Scholar