Preclinical evaluation of the immunogenicity and safety of plasmid DNA-based prophylactic vaccines for human cytomegalovirus

References

• Staras SA, Dollard SC, Radford KW, Flanders WD, Pass RF, Cannon MJ. Seroprevalence of cytomegalovirus infection in the United States, 1988-1994. Clin Infect Dis 2006; 43:1143 - 51; http://dx.doi.org/10.1086/508173; PMID: 17029132
   PubMed Web of Science ®Google Scholar
• Crough T, Khanna R. Immunobiology of human cytomegalovirus: from bench to bedside. Clin Microbiol Rev 2009; 22:76 - 98; http://dx.doi.org/10.1128/CMR.00034-08; PMID: 19136435
   PubMed Web of Science ®Google Scholar
• Landolfo S, Gariglio M, Gribaudo G, Lembo D. The human cytomegalovirus. Pharmacol Ther 2003; 98:269 - 97; http://dx.doi.org/10.1016/S0163-7258(03)00034-2; PMID: 12782241
   PubMed Web of Science ®Google Scholar
• Plotkin SA. Cytomegalovirus vaccines. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines: Saunders Elsevier, 2008:1147-54.
   Google Scholar
• Stratton KR, Durch JS, Lawrence RS. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, D.C.: Institute of Medicine, National Academy Press, 1999.
   Google Scholar
• Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol 2007; 17:253 - 76; http://dx.doi.org/10.1002/rmv.535; PMID: 17579921
   PubMed Web of Science ®Google Scholar
• Adler SP. Human CMV vaccine trials: what if CMV caused a rash?. J Clin Virol 2008; 41:231 - 6; http://dx.doi.org/10.1016/j.jcv.2007.11.008; PMID: 18096431
   PubMed Web of Science ®Google Scholar
• CDC. (Centers for Diseases Control and Prevention web site, last updated on July 28, 2010). Cytomegalovirus (CMV) and Congenital CMV Infection - Trends and Statistics. Retrieved January 17, 2012 from: http://www.cdc.gov/cmv/trends-stats.html.
   Google Scholar
• Arvin AM, Fast P, Myers M, Plotkin S, Rabinovich R, National Vaccine Advisory Committee. Vaccine development to prevent cytomegalovirus disease: report from the National Vaccine Advisory Committee. Clin Infect Dis 2004; 39:233 - 9; http://dx.doi.org/10.1086/421999; PMID: 15307033
   PubMed Web of Science ®Google Scholar
• Britt WJ, Vugler L, Butfiloski EJ, Stephens EB. Cell surface expression of human cytomegalovirus (HCMV) gp55-116 (gB): use of HCMV-recombinant vaccinia virus-infected cells in analysis of the human neutralizing antibody response. J Virol 1990; 64:1079 - 85; PMID: 2154594
   PubMed Web of Science ®Google Scholar
• Pass RF, Zhang C, Evans A, Simpson T, Andrews W, Huang ML, et al. Vaccine prevention of maternal cytomegalovirus infection. N Engl J Med 2009; 360:1191 - 9; http://dx.doi.org/10.1056/NEJMoa0804749; PMID: 19297572
   PubMed Web of Science ®Google Scholar
• Cui Z. DNA vaccine. Adv Genet 2005; 54:257 - 89; http://dx.doi.org/10.1016/S0065-2660(05)54011-2; PMID: 16096015
   PubMed Web of Science ®Google Scholar
• Kutzler MA, Weiner DB. DNA vaccines: ready for prime time?. Nat Rev Genet 2008; 9:776 - 88; http://dx.doi.org/10.1038/nrg2432; PMID: 18781156
   PubMed Web of Science ®Google Scholar
• Liu MA. DNA vaccines: an historical perspective and view to the future. Immunol Rev 2011; 239:62 - 84; http://dx.doi.org/10.1111/j.1600-065X.2010.00980.x; PMID: 21198665
   PubMed Web of Science ®Google Scholar
• Bedikian AY, Richards J, Kharkevitch D, Atkins MB, Whitman E, Gonzalez R. A phase 2 study of high-dose Allovectin-7 in patients with advanced metastatic melanoma. Melanoma Res 2010; 20:218 - 26; PMID: 20354459
   PubMed Web of Science ®Google Scholar
• Chowdhery R, Gonzalez R. Immunologic therapy targeting metastatic melanoma: allovectin-7. Immunotherapy 2011; 3:17 - 21; http://dx.doi.org/10.2217/imt.10.89; PMID: 21174553
   PubMed Web of Science ®Google Scholar
• Kharfan-Dabaja MA, Boeckh M, Wilck MB, Langston AA, Chu AH, Wloch MK, et al. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012; 12:290 - 9; http://dx.doi.org/10.1016/S1473-3099(11)70344-9; PMID: 22237175
   PubMed Web of Science ®Google Scholar
• Matijevic M, Hedley ML, Urban RG, Chicz RM, Lajoie C, Luby TM. Immunization with a poly (lactide co-glycolide) encapsulated plasmid DNA expressing antigenic regions of HPV 16 and 18 results in an increase in the precursor frequency of T cells that respond to epitopes from HPV 16, 18, 6 and 11. Cell Immunol 2011; 270:62 - 9; http://dx.doi.org/10.1016/j.cellimm.2011.04.005; PMID: 21550027
   PubMed Web of Science ®Google Scholar
• Hartikka J, Geall A, Bozoukova V, Kurniadi D, Rusalov D, Enas J, et al. Physical characterization and in vivo evaluation of poloxamer-based DNA vaccine formulations. J Gene Med 2008; 10:770 - 82; http://dx.doi.org/10.1002/jgm.1199; PMID: 18425981
   PubMed Web of Science ®Google Scholar
• Selinsky C, Luke C, Wloch M, Geall A, Hermanson G, Kaslow D, et al. A DNA-based vaccine for the prevention of human cytomegalovirus-associated diseases. Hum Vaccin 2005; 1:16 - 23; PMID: 17038834
   PubMed Web of Science ®Google Scholar
• Wloch MK, Smith LR, 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 2008; 197:1634 - 42; http://dx.doi.org/10.1086/588385; PMID: 18444883
   PubMed Web of Science ®Google Scholar
• Hartikka J, Bozoukova VV, Ferrari M, Sukhu L, Enas J, Sawdey M, et al. Vaxfectin enhances the humoral immune response to plasmid DNA-encoded antigens. Vaccine 2001; 19:1911 - 23; http://dx.doi.org/10.1016/S0264-410X(00)00445-X; PMID: 11228361
   PubMed Web of Science ®Google Scholar
• 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 2001; 19:3778 - 86; http://dx.doi.org/10.1016/S0264-410X(01)00090-1; PMID: 11395213
   PubMed Web of Science ®Google Scholar
• Sullivan SM, Doukas J, Hartikka J, Smith L, Rolland A. Vaxfectin: a versatile adjuvant for plasmid DNA- and protein-based vaccines. Expert Opin Drug Deliv 2010; 7:1433 - 46; http://dx.doi.org/10.1517/17425247.2010.538047; PMID: 21118032
   PubMed Web of Science ®Google Scholar
• Smith LR, Wloch MK, Ye M, Reyes LR, Boutsaboualoy S, Dunne CE, et al. Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. Vaccine 2010; 28:2565 - 72; http://dx.doi.org/10.1016/j.vaccine.2010.01.029; PMID: 20117262
   PubMed Web of Science ®Google Scholar
• Doukas J, Morrow J, Bellinger D, Hilgert T, Martin T, Jones D, et al. Nonclinical biodistribution, integration, and toxicology evaluations of an H5N1 pandemic influenza plasmid DNA vaccine formulated with Vaxfectin®. Vaccine 2011; 29:5443 - 52; http://dx.doi.org/10.1016/j.vaccine.2011.05.060; PMID: 21641955
   PubMed Web of Science ®Google Scholar
• Schleiss MR. Could therapeutic vaccination of cytomegalovirus-seropositive persons prevent reinfection and congenital virus transmission?. J Infect Dis 2011; 203:1513 - 6; http://dx.doi.org/10.1093/infdis/jir144; PMID: 21592979
   PubMed Web of Science ®Google Scholar
• Sabbaj S, Pass RF, Goepfert PA, Pichon S. Glycoprotein B vaccine is capable of boosting both antibody and CD4 T-cell responses to cytomegalovirus in chronically infected women. J Infect Dis 2011; 203:1534 - 41; http://dx.doi.org/10.1093/infdis/jir138; PMID: 21592981
   PubMed Web of Science ®Google Scholar
• Heldwein EE, Krummenacher C. Entry of herpesviruses into mammalian cells. Cell Mol Life Sci 2008; 65:1653 - 68; http://dx.doi.org/10.1007/s00018-008-7570-z; PMID: 18351291
   PubMed Web of Science ®Google Scholar
• Revello MG, Gerna G. Human cytomegalovirus tropism for endothelial/epithelial cells: scientific background and clinical implications. Rev Med Virol 2010; 20:136 - 55; http://dx.doi.org/10.1002/rmv.645; PMID: 20084641
   PubMed Web of Science ®Google Scholar
• Schleiss MR, Lacayo JC, Belkaid Y, McGregor A, Stroup G, Rayner J, et al. Preconceptual administration of an alphavirus replicon UL83 (pp65 homolog) vaccine induces humoral and cellular immunity and improves pregnancy outcome in the guinea pig model of congenital cytomegalovirus infection. J Infect Dis 2007; 195:789 - 98; http://dx.doi.org/10.1086/511982; PMID: 17299708
   PubMed Web of Science ®Google Scholar
• Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration?. Vaccine 2008; 26:3197 - 208; http://dx.doi.org/10.1016/j.vaccine.2008.03.095; PMID: 18486285
   PubMed Web of Science ®Google Scholar
• Hickling J, Jones R. Intradermal delivery of vaccines: a review of the literature and potential for development for use in low- and middle-income countries. Program for Appropriate Technology in Health (PATH) Report. Seattle, August 27, 2009: 94 pages. Available at: http://www.path.org/files/TS_opt_idd_review.pdf.
   Google Scholar
• Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med 2004; 351:2295 - 301; http://dx.doi.org/10.1056/NEJMoa043540; PMID: 15525714
   PubMed Web of Science ®Google Scholar
• Arnou R, Icardi G, De Decker M, Ambrozaitis A, Kazek MP, Weber F, et al. Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. Vaccine 2009; 27:7304 - 12; http://dx.doi.org/10.1016/j.vaccine.2009.10.033; PMID: 19849996
   PubMed Web of Science ®Google Scholar
• Belshe RB, Newman FK, Wilkins K, Graham IL, Babusis E, Ewell M, et al. Comparative immunogenicity of trivalent influenza vaccine administered by intradermal or intramuscular route in healthy adults. Vaccine 2007; 25:6755 - 63; http://dx.doi.org/10.1016/j.vaccine.2007.06.066; PMID: 17692438
   PubMed Web of Science ®Google Scholar
• Fynan EF, Webster RG, Fuller DH, Haynes JR, Santoro JC, Robinson HL. DNA vaccines: protective immunizations by parenteral, mucosal, and gene-gun inoculations. Proc Natl Acad Sci U S A 1993; 90:11478 - 82; http://dx.doi.org/10.1073/pnas.90.24.11478; PMID: 8265577
   PubMed Web of Science ®Google Scholar
• McCluskie MJ, Brazolot Millan CL, Gramzinski RA, Robinson HL, Santoro JC, Fuller JT, et al. Route and method of delivery of DNA vaccine influence immune responses in mice and non-human primates. Mol Med 1999; 5:287 - 300; PMID: 10390545
   PubMed Web of Science ®Google Scholar
• Arnou R, Eavis P, Pardo JR, Ambrozaitis A, Kazek MP, Weber F. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years: Randomized, controlled, phase III trial. Hum Vaccin 2010; 6:346 - 54; http://dx.doi.org/10.4161/hv.6.4.10961; PMID: 20372053
   PubMed Web of Science ®Google Scholar
• Dean HJ, Haynes J, Schmaljohn C. The role of particle-mediated DNA vaccines in biodefense preparedness. Adv Drug Deliv Rev 2005; 57:1315 - 42; http://dx.doi.org/10.1016/j.addr.2005.01.012; PMID: 15935876
   PubMed Web of Science ®Google Scholar
• Frech SA, Kenney RT, Spyr CA, Lazar H, Viret JF, Herzog C, et al. Improved immune responses to influenza vaccination in the elderly using an immunostimulant patch. Vaccine 2005; 23:946 - 50; http://dx.doi.org/10.1016/j.vaccine.2004.06.036; PMID: 15603897
   PubMed Web of Science ®Google Scholar
• Prausnitz MR, Mikszta JA, Cormier M, Andrianov AK. Microneedle-based vaccines. Curr Top Microbiol Immunol 2009; 333:369 - 93; http://dx.doi.org/10.1007/978-3-540-92165-3_18; PMID: 19768415
   PubMedGoogle Scholar
• Aguiar JC, Hedstrom RC, Rogers WO, Charoenvit Y, Sacci JB Jr., Lanar DE, et al. Enhancement of the immune response in rabbits to a malaria DNA vaccine by immunization with a needle-free jet device. Vaccine 2001; 20:275 - 80; http://dx.doi.org/10.1016/S0264-410X(01)00273-0; PMID: 11567774
   PubMed Web of Science ®Google Scholar
• Babiuk S, Baca-Estrada ME, Foldvari M, Baizer L, Stout R, Storms M, et al. Needle-free topical electroporation improves gene expression from plasmids administered in porcine skin. Mol Ther 2003; 8:992 - 8; http://dx.doi.org/10.1016/j.ymthe.2003.09.008; PMID: 14664802
   PubMed Web of Science ®Google Scholar
• Manam S, Ledwith BJ, Barnum AB, Troilo PJ, Pauley CJ, Harper LB, et al. Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Intervirology 2000; 43:273 - 81; http://dx.doi.org/10.1159/000053994; PMID: 11251382
   PubMed Web of Science ®Google Scholar
• Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin 2009; 5:623 - 6; PMID: 19779298
   PubMed Web of Science ®Google Scholar
• Wang R, Epstein J, Baraceros FM, Gorak EJ, Charoenvit Y, Carucci DJ, et al. Induction of CD4(+) T cell-dependent CD8(+) type 1 responses in humans by a malaria DNA vaccine. Proc Natl Acad Sci U S A 2001; 98:10817 - 22; http://dx.doi.org/10.1073/pnas.181123498; PMID: 11526203
   PubMed Web of Science ®Google Scholar
• Bodles-Brakhop AM, Heller R, Draghia-Akli R. Electroporation for the delivery of DNA-based vaccines and immunotherapeutics: current clinical developments. Mol Ther 2009; 17:585 - 92; http://dx.doi.org/10.1038/mt.2009.5; PMID: 19223870
   PubMed Web of Science ®Google Scholar
• Luxembourg A, Evans CF, Hannaman D. Electroporation-based DNA immunisation: translation to the clinic. Expert Opin Biol Ther 2007; 7:1647 - 64; http://dx.doi.org/10.1517/14712598.7.11.1647; PMID: 17961089
   PubMed Web of Science ®Google Scholar
• Prud’homme GJ, Glinka Y, Khan AS, Draghia-Akli R. Electroporation-enhanced nonviral gene transfer for the prevention or treatment of immunological, endocrine and neoplastic diseases. Curr Gene Ther 2006; 6:243 - 73; http://dx.doi.org/10.2174/156652306776359504; PMID: 16611045
   PubMed Web of Science ®Google Scholar
• Sardesai NY, Weiner DB. Electroporation delivery of DNA vaccines: prospects for success. Curr Opin Immunol 2011; 23:421 - 9; http://dx.doi.org/10.1016/j.coi.2011.03.008; PMID: 21530212
   PubMed Web of Science ®Google Scholar
• Vilalta A, Shlapobersky M, Wei Q, Planchon R, Rolland A, Sullivan S. Analysis of biomarkers after intramuscular injection of Vaxfectin-formulated hCMV gB plasmid DNA. Vaccine 2009; 27:7409 - 17; http://dx.doi.org/10.1016/j.vaccine.2009.08.075; PMID: 19735757
   PubMed Web of Science ®Google Scholar
• Shlapobersky M, Wei Q, Sullivan S, Vilalta A. Vaxfectin-adjuvanted seasonal influenza protein vaccine: correlation of systemic and local immunological markers with formulation parameters. Vaccine 2009; 27:6404 - 10; http://dx.doi.org/10.1016/j.vaccine.2009.06.087; PMID: 19607952
   PubMed Web of Science ®Google Scholar
• Brice GT, Dobaño C, Sedegah M, Stefaniak M, Graber NL, Campo JJ, et al. Extended immunization intervals enhance the immunogenicity and protective efficacy of plasmid DNA vaccines. Microbes Infect 2007; 9:1439 - 46; http://dx.doi.org/10.1016/j.micinf.2007.07.009; PMID: 17913540
   PubMed Web of Science ®Google Scholar
• Leitner WW, Seguin MC, Ballou WR, Seitz JP, Schultz AM, Sheehy MJ, et al. Immune responses induced by intramuscular or gene gun injection of protective deoxyribonucleic acid vaccines that express the circumsporozoite protein from Plasmodium berghei malaria parasites. J Immunol 1997; 159:6112 - 9; PMID: 9550412
   PubMed Web of Science ®Google Scholar
• Fuller DH, Corb MM, Barnett S, Steimer K, Haynes JR. Enhancement of immunodeficiency virus-specific immune responses in DNA-immunized rhesus macaques. Vaccine 1997; 15:924 - 6; http://dx.doi.org/10.1016/S0264-410X(96)00271-X; PMID: 9234549
   PubMed Web of Science ®Google Scholar
• Keitel WA, Atmar RL. Preparing for a possible pandemic: influenza A/H5N1 vaccine development. Curr Opin Pharmacol 2007; 7:484 - 90; http://dx.doi.org/10.1016/j.coph.2007.06.004; PMID: 17644429
   PubMed Web of Science ®Google Scholar
• Schleiss MR. Comparison of vaccine strategies against congenital CMV infection in the guinea pig model. J Clin Virol 2008; 41:224 - 30; http://dx.doi.org/10.1016/j.jcv.2007.10.008; PMID: 18060834
   PubMed Web of Science ®Google Scholar
• Schleiss MR, Bourne N, Bernstein DI. Preconception vaccination with a glycoprotein B (gB) DNA vaccine protects against cytomegalovirus (CMV) transmission in the guinea pig model of congenital CMV infection. J Infect Dis 2003; 188:1868 - 74; http://dx.doi.org/10.1086/379839; PMID: 14673766
   PubMed Web of Science ®Google Scholar
• Schleiss MR, Bourne N, Stroup G, Bravo FJ, Jensen NJ, Bernstein DI. Protection against congenital cytomegalovirus infection and disease in guinea pigs, conferred by a purified recombinant glycoprotein B vaccine. J Infect Dis 2004; 189:1374 - 81; http://dx.doi.org/10.1086/382751; PMID: 15073673
   PubMed Web of Science ®Google Scholar
• Jimenez GS, 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 2007; 3:157 - 64; http://dx.doi.org/10.4161/hv.3.5.4175; PMID: 17637571
   PubMed Web of Science ®Google Scholar
• Leamy VL, Martin T, Mahajan R, Vilalta A, Rusalov D, Hartikka J, et al. Comparison of rabbit and mouse models for persistence analysis of plasmid-based vaccines. Hum Vaccin 2006; 2:113 - 8; PMID: 17012905
   PubMed Web of Science ®Google Scholar
• Hebel H, Attra H, Khan A, Draghia-Akli R. Successful parallel development and integration of a plasmid-based biologic, container/closure system and electrokinetic delivery device. Vaccine 2006; 24:4607 - 14; http://dx.doi.org/10.1016/j.vaccine.2005.08.049; PMID: 16150516
   PubMed Web of Science ®Google Scholar
• Khan AS, Pope MA, Draghia-Akli R. Highly efficient constant-current electroporation increases in vivo plasmid expression. DNA Cell Biol 2005; 24:810 - 8; http://dx.doi.org/10.1089/dna.2005.24.810; PMID: 16332178
   PubMed Web of Science ®Google Scholar