Developments in Viral Vector-Based Vaccines

Jackson, 1972, Biochemical method for inserting new genetic information into DNA of Simian Virus 40: Circular SV40 DNA molecules containing lambda phage genes and the galactose operon of Escherichia coli, Proc. Natl. Acad. Sci. USA, 69, 2904, 10.1073/pnas.69.10.2904

Mackett, 1982, Vaccinia virus: A selectable eukaryotic cloning and expression vector, Proc. Natl. Acad. Sci. USA, 79, 7415, 10.1073/pnas.79.23.7415

Panicali, 1982, Construction of poxviruses as cloning vectors: Insertion of the thymidine kinase gene from herpes simplex virus into the DNA of infectious vaccinia virus, Proc. Natl. Acad. Sci. USA, 79, 4927, 10.1073/pnas.79.16.4927

Akira, 2006, Pathogen recognition and innate immunity, Cell, 124, 783, 10.1016/j.cell.2006.02.015

Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines. Available online:http://www.google.co.jp/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB4QFjAA&url=http%3A%2F%2Fwww.ema.europa.eu%2Fdocs%2Fen_GB%2Fdocument_library%2FScientific_guideline%2F2010%2F08%2FWC500095721.pdf&ei=ekqeU4KVBZfh8AXy04CIDQ&usg=AFQjCNGp5tFdi8xYzi_hgA9HS6-eczxN7A&bvm=bv.68911936,d.dGc.

Gross, 2000, Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease, Science, 288, 669, 10.1126/science.288.5466.669

Tebas, 2013, Antiviral effects of autologous CD4 T cells genetically modified with a conditionally replicating lentiviral vector expressing long antisense to HIV, Blood, 121, 1524, 10.1182/blood-2012-07-447250

Dropulic, 1996, A conditionally replicating HIV-1 vector interferes with wild-type HIV-1 replication and spread, Proc. Natl. Acad. Sci. USA, 93, 11103, 10.1073/pnas.93.20.11103

Pitisuttithum, 2009, Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand, N. Engl. J. Med., 361, 2209, 10.1056/NEJMoa0908492

Sekaly, 2008, The failed HIV Merck vaccine study: A step back or a launching point for future vaccine development? J, Exp. Med., 205, 7, 10.1084/jem.20072681

Ferreira, V., Petry, H., and Salmon, F. (2014). Immune responses to AAV-Vectors, the glybera example from bench to bedside. Front. Immunol., 5.

Hansen, 2011, Profound early control of highly pathogenic SIV by an effector memory T-cell vaccine, Nature, 473, 523, 10.1038/nature10003

Slobod, 2004, Safety and immunogenicity of intranasal murine parainfluenza virus type 1 (Sendai virus) in healthy human adults, Vaccine, 22, 3182, 10.1016/j.vaccine.2004.01.053

Stickl, 1974, MVA vaccination against smallpox: Clinical tests with an attenuated live vaccinia virus strain (MVA) (author’ transl), Dtsch. Med. Wochenschr., 99, 2386, 10.1055/s-0028-1108143

Hashizume, 1975, A new attenuated strain of vaccinia virus, LC 16m8: Basic information, J. Clin. Virol., 3, 229

Gomez, 2011, MVA and NYVAC as vaccines against emergent infectious diseases and cancer, Curr. Gene Ther., 11, 189, 10.2174/156652311795684731

Sutter, 2003, Vaccinia vectors as candidate vaccines: The development of modified vaccinia virus Ankara for antigen delivery, Curr. Drug Targets Infect. Disord., 3, 263, 10.2174/1568005033481123

Zhu, 2007, Innate immunity against vaccinia virus is mediated by TLR2 and requires TLR-independent production of IFN-beta, Blood, 109, 619, 10.1182/blood-2006-06-027136

Price, 2013, Modified vaccinia virus Ankara: Innate immune activation and induction of cellular signalling, Vaccine, 31, 4231, 10.1016/j.vaccine.2013.03.017

Gomez, 2011, The HIV/AIDS vaccine candidate MVA-B administered as a single immunogen in humans triggers robust, polyfunctional, and selective effector memory T cell responses to HIV-1 antigens, J. Virol., 85, 11468, 10.1128/JVI.05165-11

Garcia, 2011, Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02), Vaccine, 29, 8309, 10.1016/j.vaccine.2011.08.098

Bakari, 2011, Broad and potent immune responses to a low dose intradermal HIV-1 DNA boosted with HIV-1 recombinant MVA among healthy adults in Tanzania, Vaccine, 29, 8417, 10.1016/j.vaccine.2011.08.001

Cavenaugh, 2011, Partially randomized, non-blinded trial of DNA and MVA therapeutic vaccines based on hepatitis B virus surface protein for chronic HBV infection, PLoS One, 6, e14626, 10.1371/journal.pone.0014626

Berthoud, 2011, Potent CD8+ T-cell immunogenicity in humans of a novel heterosubtypic influenza A vaccine, MVA-NP+M1, Clin. Infect. Dis., 52, 1, 10.1093/cid/ciq015

Bejon, 2007, Extended follow-up following a phase 2b randomized trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya, PLoS One, 2, e707, 10.1371/journal.pone.0000707

Sheehy, 2012, Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors, PLoS One, 7, e31208, 10.1371/journal.pone.0031208

Tameris, 2013, Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: A randomised, placebo-controlled phase 2b trial, Lancet, 381, 1021, 10.1016/S0140-6736(13)60177-4

Chan, 2013, Oncolytic myxoma virus: The path to clinic, Vaccine, 31, 4252, 10.1016/j.vaccine.2013.05.056

Gilbert, 2013, Clinical development of modified vaccinia virus Ankara vaccines, Vaccine, 31, 4241, 10.1016/j.vaccine.2013.03.020

Frey, 2013, Safety and immunogenicity of IMVAMUNE(R) smallpox vaccine using different strategies for a post event scenario, Vaccine, 31, 3025, 10.1016/j.vaccine.2013.04.050

Jordan, 2011, A chemically defined production process for highly attenuated poxviruses, Biologicals, 39, 50, 10.1016/j.biologicals.2010.11.005

Brown, 2010, The avian EB66(R) cell line, application to vaccines, and therapeutic protein production, PDA J. Pharm. Sci. Technol., 64, 419

Cooney, 1991, Safety of and immunological response to a recombinant vaccinia virus vaccine expressing HIV envelope glycoprotein, Lancet, 337, 567, 10.1016/0140-6736(91)91636-9

Gudmundsdotter, 2009, Recombinant Modified Vaccinia Ankara (MVA) effectively boosts DNA-primed HIV-specific immune responses in humans despite pre-existing vaccinia immunity, Vaccine, 27, 4468, 10.1016/j.vaccine.2009.05.018

Harrop, 2006, Vaccination of colorectal cancer patients with modified vaccinia Ankara delivering the tumor antigen 5T4 (TroVax) induces immune responses which correlate with disease control: A phase I/II trial, Clin. Cancer Res., 12, 3416, 10.1158/1078-0432.CCR-05-2732

Davison, 1990, New vaccinia virus recombination plasmids incorporating a synthetic late promoter for high level expression of foreign proteins, Nucleic Acids Res., 18, 4285, 10.1093/nar/18.14.4285

Falivene, 2012, Improving the MVA vaccine potential by deleting the viral gene coding for the IL-18 binding protein, PLoS One, 7, e32220, 10.1371/journal.pone.0032220

Sumida, 2005, Neutralizing antibodies to adenovirus serotype 5 vaccine vectors are directed primarily against the adenovirus hexon protein, J. Immunol., 174, 7179, 10.4049/jimmunol.174.11.7179

Wohlfart, 1988, Neutralization of adenoviruses: Kinetics, stoichiometry, and mechanisms, J. Virol., 62, 2321, 10.1128/jvi.62.7.2321-2328.1988

Schnurr, 1996, Analysis of 15 adenovirus hexon proteins reveals the location and structure of seven hypervariable regions containing serotype-specific residues, J. Virol., 70, 1836, 10.1128/jvi.70.3.1836-1844.1996

Roberts, 2006, Hexon-chimaeric adenovirus serotype 5 vectors circumvent pre-existing anti-vector immunity, Nature, 441, 239, 10.1038/nature04721

Ura, 2009, Designed recombinant adenovirus type 5 vector induced envelope-specific CD8+ cytotoxic T lymphocytes and cross-reactive neutralizing antibodies against human immunodeficiency virus type 1, J. Gene Med., 11, 139, 10.1002/jgm.1277

Abe, 2009, Adenovirus type 5 with modified hexons induces robust transgene-specific immune responses in mice with pre-existing immunity against adenovirus type 5, J. Gene Med., 11, 570, 10.1002/jgm.1332

Yang, 1994, Cellular immunity to viral antigens limits E1-deleted adenoviruses for gene therapy, Proc. Natl. Acad. Sci. USA, 91, 4407, 10.1073/pnas.91.10.4407

Xin, 2005, Prime-boost vaccination with plasmid DNA and a chimeric adenovirus type 5 vector with type 35 fiber induces protective immunity against HIV, Gene Ther., 12, 1769, 10.1038/sj.gt.3302590

Gao, 1996, Biology of adenovirus vectors with E1 and E4 deletions for liver-directed gene therapy, J. Virol., 70, 8934, 10.1128/jvi.70.12.8934-8943.1996

Okada, 2005, Immunological properties and vaccine efficacy of murine dendritic cells simultaneously expressing melanoma-associated antigen and interleukin-12, Cancer Gene Ther., 12, 72, 10.1038/sj.cgt.7700772

Hammer, 2013, Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine, N. Engl. J. Med., 369, 2083, 10.1056/NEJMoa1310566

Kibuuka, 2010, A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172), J. Infect. Dis., 201, 600, 10.1086/650299

Gurwith, 2013, Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: A randomised, double-blind, placebo-controlled, phase 1 study, Lancet Infect. Dis., 13, 238, 10.1016/S1473-3099(12)70345-6

Diaz, C.M., Chiappori, A., Aurisicchio, L., Bagchi, A., Clark, J., Dubey, S., Fridman, A., Fabregas, J.C., Marshall, J., and Scarselli, E. (2013). Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J. Transl. Med., 11.

Catanzaro, 2006, Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector, J. Infect. Dis., 194, 1638, 10.1086/509258

Perreau, 2008, Activation of a dendritic cell-T cell axis by Ad5 immune complexes creates an improved environment for replication of HIV in T cells, J. Exp. Med., 205, 2717, 10.1084/jem.20081786

Smaill, F., Jeyanathan, M., Smieja, M., Medina, M.F., Thanthrige-Don, N., Zganiacz, A., Yin, C., Heriazon, A., Damjanovic, D., and Puri, L. (2013). A human type 5 adenovirus-based tuberculosis vaccine induces robust T cell responses in humans despite preexisting anti-adenovirus immunity. Sci. Transl. Med., 5.

Gao, 2002, Novel adeno-associated viruses from rhesus monkeys as vectors for human gene therapy, Proc. Natl. Acad. Sci. USA, 99, 11854, 10.1073/pnas.182412299

Xiao, 1999, Gene therapy vectors based on adeno-associated virus type 1, J. Virol., 73, 3994, 10.1128/JVI.73.5.3994-4003.1999

Halbert, 2001, Adeno-associated virus type 6 (AAV6) vectors mediate efficient transduction of airway epithelial cells in mouse lungs compared to that of AAV2 vectors, J. Virol., 75, 6615, 10.1128/JVI.75.14.6615-6624.2001

Zabner, 2000, Adeno-associated virus type 5 (AAV5) but not AAV2 binds to the apical surfaces of airway epithelia and facilitates gene transfer, J. Virol., 74, 3852, 10.1128/JVI.74.8.3852-3858.2000

Fan, 1998, Behavioral recovery in 6-hydroxydopamine-lesioned rats by cotransduction of striatum with tyrosine hydroxylase and aromatic L-amino acid decarboxylase genes using two separate adeno-associated virus vectors, Hum. Gene Ther., 9, 2527, 10.1089/hum.1998.9.17-2527

Herzog, 1997, Stable gene transfer and expression of human blood coagulation factor IX after intramuscular injection of recombinant adeno-associated virus, Proc. Natl. Acad. Sci. USA, 94, 5804, 10.1073/pnas.94.11.5804

Flotte, 1993, Stable in vivo expression of the cystic fibrosis transmembrane conductance regulator with an adeno-associated virus vector, Proc. Natl. Acad. Sci. USA, 90, 10613, 10.1073/pnas.90.22.10613

During, 1998, Peroral gene therapy of lactose intolerance using an adeno-associated virus vector, Nat. Med., 4, 1131, 10.1038/2625

Snyder, 1997, Persistent and therapeutic concentrations of human factor IX in mice after hepatic gene transfer of recombinant AAV vectors, Nat. Genet., 16, 270, 10.1038/ng0797-270

Lewin, 1998, Ribozyme rescue of photoreceptor cells in a transgenic rat model of autosomal dominant retinitis pigmentosa, Nat. Med., 4, 967, 10.1038/nm0898-967

Urabe, 2002, Insect cells as a factory to produce adeno-associated virus type 2 vectors, Hum. Gene Ther., 13, 1935, 10.1089/10430340260355347

Kotin, 2011, Large-scale recombinant adeno-associated virus production, Hum. Mol. Genet., 20, R2, 10.1093/hmg/ddr141

Choi, 2005, AAV hybrid serotypes: Improved vectors for gene delivery, Curr. Gene Ther., 5, 299, 10.2174/1566523054064968

Donsante, 2001, Observed incidence of tumorigenesis in long-term rodent studies of rAAV vectors, Gene Ther., 8, 1343, 10.1038/sj.gt.3301541

Li, 2011, Assessing the potential for AAV vector genotoxicity in a murine model, Blood, 117, 3311, 10.1182/blood-2010-08-302729

Kaplitt, 2007, Safety and tolerability of gene therapy with an adeno-associated virus (AAV) borne GAD gene for Parkinson’s disease: An open label, phase I trial, Lancet, 369, 2097, 10.1016/S0140-6736(07)60982-9

Mandel, 2010, CERE-110, an adeno-associated virus-based gene delivery vector expressing human nerve growth factor for the treatment of Alzheimer’s disease, Curr. Opin. Mol. Ther., 12, 240

Shimada, 2013, Prophylaxis and treatment of Alzheimer’s disease by delivery of an adeno-associated virus encoding a monoclonal antibody targeting the amyloid Beta protein, PLoS One, 8, e57606, 10.1371/journal.pone.0057606

Jessup, 2011, Calcium upregulation by percutaneous administration of gene therapy in cardiac disease (CUPID): A phase 2 trial of intracoronary gene therapy of sarcoplasmic reticulum Ca2+-ATPase in patients with advanced heart failure, Circulation, 124, 304, 10.1161/CIRCULATIONAHA.111.022889

Carter, 2005, Adeno-associated virus vectors in clinical trials, Hum. Gene Ther., 16, 541, 10.1089/hum.2005.16.541

Xin, 2001, A novel recombinant adeno-associated virus vaccine induces a long-term humoral immune response to human immunodeficiency virus, Hum. Gene Ther., 12, 1047, 10.1089/104303401750214276

Xin, 2002, Oral administration of recombinant adeno-associated virus elicits human immunodeficiency virus-specific immune responses, Hum. Gene Ther., 13, 1571, 10.1089/10430340260201662

Xin, 2006, Induction of robust immune responses against human immunodeficiency virus is supported by the inherent tropism of adeno-associated virus type 5 for dendritic cells, J. Virol., 80, 11899, 10.1128/JVI.00890-06

Lin, 2009, A new genetic vaccine platform based on an adeno-associated virus isolated from a rhesus macaque, J. Virol., 83, 12738, 10.1128/JVI.01441-09

Nieto, 2012, Intranasal vaccination with AAV5 and 9 vectors against human papillomavirus type 16 in rhesus macaques, Hum. Gene Ther., 23, 733, 10.1089/hum.2011.202

Ram, 1997, Therapy of malignant brain tumors by intratumoral implantation of retroviral vector-producing cells, Nat. Med., 3, 1354, 10.1038/nm1297-1354

Gaspar, 2004, Gene therapy of X-linked severe combined immunodeficiency by use of a pseudotyped gammaretroviral vector, Lancet, 364, 2181, 10.1016/S0140-6736(04)17590-9

Li, Z., Dullmann, J., Schiedlmeier, B., Schmidt, M., von Kalle, C., Meyer, J., Forster, M., Stocking, C., Wahlers, A., and Frank, O. (2002). Murine leukemia induced by retroviral gene marking. Science, 296.

Modlich, 2005, Leukemias following retroviral transfer of multidrug resistance 1 (MDR1) are driven by combinatorial insertional mutagenesis, Blood, 105, 4235, 10.1182/blood-2004-11-4535

Maruggi, 2009, Transcriptional enhancers induce insertional gene deregulation independently from the vector type and design, Mol. Ther., 17, 851, 10.1038/mt.2009.51

Montini, 2009, The genotoxic potential of retroviral vectors is strongly modulated by vector design and integration site selection in a mouse model of HSC gene therapy, J. Clin. Invest., 119, 964, 10.1172/JCI37630

Thornhill, 2008, Self-inactivating gammaretroviral vectors for gene therapy of X-linked severe combined immunodeficiency, Mol. Ther., 16, 590, 10.1038/sj.mt.6300393

Schroers, 2000, Transduction of human PBMC-derived dendritic cells and macrophages by an HIV-1-based lentiviral vector system, Mol. Ther., 1, 171, 10.1006/mthe.2000.0027

Kobinger, 2001, Filovirus-pseudotyped lentiviral vector can efficiently and stably transduce airway epithelia in vivo, Nat. Biotechnol., 19, 225, 10.1038/85664

Watson, 2002, Targeted transduction patterns in the mouse brain by lentivirus vectors pseudotyped with VSV, Ebola, Mokola, LCMV, or MuLV envelope proteins, Mol. Ther., 5, 528, 10.1006/mthe.2002.0584

Frecha, 2008, Stable transduction of quiescent T cells without induction of cycle progression by a novel lentiviral vector pseudotyped with measles virus glycoproteins, Blood, 112, 4843, 10.1182/blood-2008-05-155945

Sinn, 2003, Lentivirus vectors pseudotyped with filoviral envelope glycoproteins transduce airway epithelia from the apical surface independently of folate receptor alpha, J. Virol., 77, 5902, 10.1128/JVI.77.10.5902-5910.2003

Pistello, 2010, Env-expressing autologous T lymphocytes induce neutralizing antibody and afford marked protection against feline immunodeficiency virus, J. Virol., 84, 3845, 10.1128/JVI.02638-09

Chiuppesi, 2012, A lentiviral vector-based, herpes simplex virus 1 (HSV-1) glycoprotein B vaccine affords cross-protection against HSV-1 and HSV-2 genital infections, J. Virol., 86, 6563, 10.1128/JVI.00302-12

Hansen, S.G., Sacha, J.B., Hughes, C.M., Ford, J.C., Burwitz, B.J., Scholz, I., Gilbride, R.M., Lewis, M.S., Gilliam, A.N., and Ventura, A.B. (2013). Cytomegalovirus vectors violate CD8+ T cell epitope recognition paradigms. Science, 340.

Hara, 2011, Prevalence of specific neutralizing antibodies against Sendai virus in populations from different geographic areas: Implications for AIDS vaccine development using Sendai virus vectors, Hum. Vaccin., 7, 639, 10.4161/hv.7.6.15408

Moriya, 2011, Intranasal Sendai viral vector vaccination is more immunogenic than intramuscular under pre-existing anti-vector antibodies, Vaccine, 29, 8557, 10.1016/j.vaccine.2011.09.028

Nakanishi, 2012, Development of Sendai virus vectors and their potential applications in gene therapy and regenerative medicine, Curr. Gene Ther., 12, 410, 10.2174/156652312802762518

Shimada, 2009, Effect of therapeutic immunization using Ad5/35 and MVA vectors on SIV infection of rhesus monkeys undergoing antiretroviral therapy, Gene Ther., 16, 218, 10.1038/gt.2008.152

Wang, 2010, Partial protection against SIV challenge by vaccination of adenovirus and MVA vectors in rhesus monkeys, Gene Ther., 17, 4, 10.1038/gt.2009.122

Yashima, 2010, Co-administration of viral vector-based vaccines suppresses antigen-specific effector CD8 T cells, Vaccine, 28, 3257, 10.1016/j.vaccine.2010.01.065