Publications

Published research describing technology licensed and developed by Auro Vaccines

Auro Vaccines Clinical Trial Publications

D.K. Clarke, R. Xu, D. Matassov, T.E. Latham, A. Ota-Setlik, C.S. Gerardi, A. Luckay, S.E. Witko, L. Hermida, T. Higgins, M. Tremblay, S. Sciotto-Brown, T. Chen, M.A. Egan, J.M. Rusnak, L.A. Ward, J.H. Eldridge. Safety and Immunogenicity of a Highly Attenuated rVSVN4CT1-EBOVGP1 Ebola Virus Vaccine in a Randomized, Double-Blinded, Placebo-Controlled Phase I Clinical Trial. Lancet Infect Dis 2020;20: 455–66.

M.L. Elizaga, S.S. Li, N. Kochar, G.J. Wilson, M. Allen, H.V. Tieu, I. Frank, M.E. Sobieszczyk, K. Cohen, B. Sanchez, T.E. Latham, D.K. Clarke, M.A. Egan, J.H. Eldridge, D. Hannaman, R. Xu, A. Ota-Setlik, M.J. McElrath, C.M. Hay, on behalf of the HVTN 087 Protocol Team and the NIAID HIV Vaccine Trials Network. Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers. PLoS One, 2018 Sep 20;13(9):e0202753.

M.C. Sneller, J.S. Justement, K.R. Gittens, M.E. Petrone, K.E. Clarridge, M.A. Proschan, R. Kwan, V. Shi, J. Blazkova, E.W. Refsland, D.E. Morris, K.W. Cohen, M.J. McElrath, R. Xu, M.A. Egan, J.H. Eldridge, E. Benko, C. Kovacs, S. Moir, T.-W. Chun, and A.S. Fauci. A randomized controlled trial of the safety and efficacy of therapeutic vaccination in HIVinfected individuals who initiated antiretroviral therapy during acute/early phase of infection. Sci Transl Med. 2017 Dec 6;9(419).

S.S. Li, N. Kochar, M. Elizaga, C. Hay, G. Wilson, K. Cohen, S. De Rosa, R. Xu, A. Ota-Setlik, D. Morris, G. Finak, M. Allen, H-V. Tieu, I. Frank, M. Sobieszczyk, D. Hannaman, R. Gottardo, P. Gilbert, G. Tomaras, L. Corey, D. Clarke, M.A. Egan, J. Eldridge, M. McElrath, and N. Frahm.  DNA priming increases frequency of T-cell responses to a VSV HIV vaccine with specific enhancement of CD8+ T-cell responses by IL-12 pDNA. Clin Vaccine Immunol. 2017 Nov 6;24(11).

J. M Jacobson, L. Zheng, C.C. Wilson, P. Tebas, R.M. Matining, M.A. Egan, Michael A J. Eldridge, A.L. Landay, D.B. Clifford, A.F. Luetkemeyer, J. Tiu, A. L. Martinez, J. Janik, T.A. Spitz, J. Hural, J. McElrath, N. Frahm, ACTG A5281 Protocol Team. The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection. J Acquir Immune Defic Syndr. 71(2): 163-171 (2016).

J. Mpendo, G. Mutua, J. Nyombayire, R. Ingabire, A. Nanvubya, O. Anzala, E. Karita, P. Hayes, J. Kopycinski, L. Dally, D. Hannaman, M.A. Egan, J.H. Eldridge, K. Syvertsen, J. Lehrman, B. Rasmussen, J. Gilmour, J.H. Cox, P.E. Fast, C. Schmidt. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vaccine in Healthy HIV-Seronegative African Adults. PLoS One.;10(8):e0134287. doi: 10.1371/journal.pone.0134287 (2015).

J. D. Fuchs, I. Frank, M. L. Elizaga, M. Allen, N. Frahm, N. Kochar, S. Li, S. Edupuganti, S. Kalams, G.D. Tomaras, R. Sheets, M. Pensiero, M.A. Tremblay, T.J. Higgins, T. Latham, M.A. Egan, D.K. Clarke, and J.H. Eldridge for the HVTN 090 Study Group and the National Institutes of Allergy Infectious Diseases HIV Vaccine Trials Network. First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus (rVSV) HIV-1 gag Vaccine (HVTN 090), Open Forum Infect Dis., Vol.2 No. 3 doi:10.1093/ofid/ofv082 (2015).

Recombinant Vesicular Stomatitis Virus

RW Cross, R Xu, D Matassov, S Hamm, TE Latham, CS Gerardi, RM Nowak, JB Geisbert, A Ota-Setlik, KN Agans, A Luckay, SE Witko, L Soukieh, DJ Deer, CE Mire, H Feldmann, C Happi, KA Fenton, JH Eldridge, TW Geisbert.  Quadrivalent VesiculoVax vaccine protects nonhuman primates from viral-induced hemorrhagic fever and death. J Clin Invest. 2020;130(1):539-551.

D. Matassov, C. Mire, T. Latham, J. Geisbert, R. Xu, A. Ota-Setlik, K. Agans, D. Kobs, M. Wendling, A. Burnaugh, T. Rudge, C. Sabourin, M.A. Egan, D. Clarke, T. Geisbert, and J.H. Eldridge. Single Dose Trivalent Vesiculovax Vaccine Protects Macaques from Lethal Ebolavirus and Marburgvirus Challenge. J Virol. 2017 Nov 15. pii: JVI.01190-17.

Egan MA. Filovirus rVSV Vaccines. Keystone Symposia on Hemorrhagic Fever Viruses. December 4-9, 2016.

Matassov D, Mire CE, Price J, Xu R, Latham T, Ota-Setlik A, Rudge T, Geisbert JB, Agans KN, Fenton KA, Kilgore N, Sabourin C, Bounds C, Badorrek C, Ward L, Burnaugh A, Dorsey C, Sciotto-Brown S, Higgins T, Tremblay M, Egan M, Clarke D, Geisbert TW, Eldridge JH. Phase 1 Safety and Immunogenicity of an Attenuated VesiculoVax™ Vectored EBOV Vaccine (presentation). 8th International Symposium on Filoviruses. September 12-15, 2016.

Matassov D, Mire CE, Price J, Xu R, Latham T, Ota-Setlik A, Rudge T, Geisbert JB, Agans KN, Fenton KA, Kilgore N, Sabourin C, Bounds C, Badorrek C, Ward L, Burnaugh A, Dorsey C, Sciotto-Brown S, Higgins T, Tremblay M, Egan M, Clarke D, Geisbert TW, Eldridge JH. Phase 1 Safety and Immunogenicity of an Attenuated VesiculoVax™ Vectored EBOV Vaccine (abstract). 8th International Symposium on Filoviruses. September 12-15, 2016.

D. Matassov, A. Marzi, T. Latham, R. Xu, A. Ota-Setlik, F. Feldmann, J.B. Geisbert, C.E. Mire, S. Hamm, B. Nowak, M.A. Egan, T.W. Geisbert, J.H. Eldridge, H. Feldmann and D.K. Clarke. Vaccination With a Highly Attenuated Recombinant Vesicular Stomatitis Virus Vector Protects Against Challenge With a Lethal Dose of Ebola Virus. J. Infect. Dis., 212:S443-51 (2015)

C.E. Mire, D. Matassov, J.B. Geisbert, T.E. Latham, K.N. Agans, R. Xu, A. Ota-Setlik, M.A. Egan, K.A. Fenton, D.K. Clarke, J.H. Eldridge, T.W. Geisbert. Single-dose attenuated Vesiculovax vaccines protect primates against Ebola Makona virus. Nature. 2015; advance online publication. doi: 10.1038/nature14428.

D.K. Clarke, F. Nasar, S. Chong, J.E. Johnson, J.W. Coleman, M. Lee, S.E. Witko, C.S. Kotash, R. Abdullah, S. Megati, A. Luckay, B. Nowak, A. Lackner, R.E. Price, P. Little, N. Kalyan, V. Randolf, A. Javadian, T.J. Zamb, C.L. Parks, M.A. Egan, J. Eldridge, M. Hendry, S.A. Udem. Neurovirulence and Immunogenicity of Attenuated Recombinant Vesicular Stomatitis Viruses in Nonhuman Primates. J. Virol. 88(12):6690 (2014).

R. Xu, F. Nasar, S. Megati, A. Luckay, M. Lee, S. A. Udem, J. H. Eldridge, M. A. Egan, E. Emini, and D. K. Clarke. Prime-Boost Vaccination with Recombinant Mumps Virus and Recombinant Vesicular Stomatitis Virus Vectors Elicits an Enhanced HIV-1 Gag-Specific Cellular Immune Response in Rhesus Macaques.  J. Virol., 83:9813-23 (2009).

Cooper D, Wright KJ, Calderon PC, Guo M, Nasar F, Johnson JE, Coleman JW, Lee M, Kotash C, Yurgelonis I, Natuk RJ, Hendry RM, Udem SA, Clarke DK. Attenuation of recombinant vesicular stomatitis virus-human immunodeficiency virus type 1 vaccine vectors by gene translocations and g gene truncation reduces neurovirulence and enhances immunogenicity in mice. J Virol. 2008 Jan;82(1):207-19. Epub 2007 Oct 17.

Liao JB, Publicover J, Rose JK, DiMaio D. Single-dose, therapeutic vaccination of mice with vesicular stomatitis virus expressing human papillomavirus type 16 E7 protein. Clin Vaccine Immunol. (2008) 15:817-24.

Schwartz JA, Buonocore L, Roberts A, Suguitan A Jr, Kobasa D, Kobinger G, Feldmann H, Subbarao K, Rose JK. Vesicular stomatitis virus vectors expressing avian influenza H5 HA induce cross-neutralizing antibodies and long-term protection. Virology (2007) 366:166-73.

Brandsma JL, Shylankevich M, Su Y, Roberts A, Rose JK, Zelterman D, Buonocore L. Vesicular stomatitis virus-based therapeutic vaccination targeted to the E1, E2, E6, and E7 proteins of cottontail rabbit papillomavirus. J Virol. (2007)81:5749-58.

Brandsma JL, Shlyankevich M, Buonocore L, Roberts A, Becker SM, Rose JK. Therapeutic efficacy of vesicular stomatitis virus-based E6 vaccination in rabbits. Vaccine (2007) 25:751-62.

D. Clarke, D. Cooper, M. A. Egan, R. M. Hendry, C. Parks, S. Udem Recombinant Vesicular Stomatitis Virus as an HIV-1 Vaccine Vector. Springer Semin Immunopathol, 28:239-253 (2006).

M. A. Egan, S-Y. Chong, S. Megati D. C. Montefiori, N. F. Rose, M. Sidhu, J. Quiroz, E. B. Schadeck, G. Pavlakis, D. B. Weiner, J. K. Rose, Z. R. Israel, S. A. Udem and J. H. Eldridge. Priming with Plasmid DNAs Expressing IL-12 and SIV Gag Protein Enhances the Immunogenicity and Efficacy of an Experimental AIDS Vaccine Based on Recombinant Vesicular Stomatitis Virus. AIDS Res. Human Retroviruses (2005) 21:629-643.

Egan MA, Chong SY, Rose NF, Megati S, Lopez KJ, Schadeck EB, Johnson JE, Masood A, Piacente P, Druilhet RE, Barras PW, Hasselschwert DL, Reilly P, Mishkin EM, Montefiori DC, Lewis MG, Clarke DK, Hendry RM, Marx PA, Eldridge JH, Udem SA, Israel ZR, Rose JK. Immunogenicity of attenuated vesicular stomatitis virus vectors expressing HIV type 1 Env and SIV Gag proteins: comparison of intranasal and intramuscular vaccination routes. AIDS Res Hum Retroviruses (2004) 20:989-1004.

Roberts A, Reuter JD, Wilson JH, Baldwin S, Rose JK.  Complete protection from papillomavirus challenge after a single vaccination with a vesicular stomatitis virus vector expressing high levels of L1 protein. J Virol. (2004)78:3196-9.

Reuter JD, Vivas-Gonzalez BE, Gomez D, Wilson JH, Brandsma JL, Greenstone HL, Rose JK, Roberts A. Intranasal vaccination with a recombinant vesicular stomatitis virus expressing cottontail rabbit papillomavirus L1 protein provides complete protection against papillomavirus-induced disease. J Virol. 2002, 76:8900-9. Erratum in: J Virol. (2003) 77:2799.

Haglund K, Leiner I, Kerksiek K, Buonocore L, Pamer E, Rose JK.  Robust recall and long-term memory T-cell responses induced by prime-boost regimens with heterologous live viral vectors expressing human immunodeficiency virus type 1 Gag and Env proteins. J Virol. (2002) 76:7506-17.

Buonocore L, Blight KJ, Rice CM, Rose JK. Characterization of vesicular stomatitis virus recombinants that express and incorporate high levels of hepatitis C virus glycoproteins. J Virol. (2002) 76:6865-72.

Haglund K, Leiner I, Kerksiek K, Buonocore L, Pamer E, Rose JK. High-level primary CD8(+) T-cell response to human immunodeficiency virus type 1 gag and env generated by vaccination with recombinant vesicular stomatitis viruses. J Virol. 2002, 76:2730-8.

Rose NF, Marx PA, Luckay A, Nixon DF, Moretto WJ, Donahoe SM, Montefiori D, Roberts A, Buonocore L, Rose JK. An effective AIDS vaccine based on live attenuated vesicular stomatitis virus recombinants. Cell (2001) 106:539-49.

Rose NF, Roberts A, Buonocore L, Rose JK. Glycoprotein exchange vectors based on vesicular stomatitis virus allow effective boosting and generation of neutralizing antibodies to a primary isolate of human immunodeficiency virus type 1. J Virol. (2000) 74:10903-10.

Haglund K, Forman J, Kräusslich HG, Rose JK. Expression of human immunodeficiency virus type 1 Gag protein precursor and envelope proteins from a vesicular stomatitis virus recombinant: high-level production of virus-like particles containing HIV envelope. Virology (2000) 268:112-21.

Roberts A, Buonocore L, Price R, Forman J, Rose JK. Attenuated vesicular stomatitis viruses as vaccine vectors. J Virol. (1999) 73:3723-32.

Lawson ND, Stillman EA, Whitt MA, Rose JK. Recombinant vesicular stomatitis viruses from DNA. Proc Natl Acad Sci U S A. 1995, 92:4477-81. Erratum in: Proc Natl Acad Sci U S A (1995) 92:9009.

pDNA Vaccines

K. Bagley, R. Xu, A. Ota-Setlik, M. Egan, J. Schwartz, T. Fouts. The catalytic A1 domains of cholera toxin and heat-labile enterotoxin are potent DNA adjuvants that evoke mixed Th1/Th17 cellular immune responses. Human Vaccines & Immunotherapeutics: 00-. doi: 10.1080/21645515.2015.1026498 (2015).

R. Xu, S. Megati, V. Roopchand, A. Luckay, A. Masood, D. Garcia-Hand, M. Rosati, D. B. Weiner, B. K. Felber, G. N. Pavlakis, M. K. Sidhu, J. H. Eldridge and M. A. Egan. Comparative ability of various plasmid-based cytokines and chemokines to adjuvant the activity of HIV plasmid DNA vaccines. Vaccine 26:4819-29 (2008).

S. Megati, S. Cappello, V. Roopchand, D. Garcia-Hand, A. Masood, R. Xu, A. Luckay, S-Y. Chong, M. Rosati, S. Sackitey, D. B. Weiner, B. K. Felber, G. N. Pavlakis, Z. R. Israel, J. H. Eldridge, M. K. Sidhu and M. A. Egan. Modifying the HIV-1 env gp160 gene to improve pDNA vaccine-elicited cell mediated immune responses. Vaccine (2008) 26:5083-5094.

M. A. Egan. Towards the Development of a Therapeutic Vaccine for the Treatment of HIV-1 Infection: Are We Closer Than Ever? Expert Rev. Vaccines (2007) 6:289-291.

Luckay, M. K. Sidhu, R. Kjeken, S. Megati, S.-Yen Chong, V. Roopchand, D. Garcia-Hand, R. Abdullah, R. Braun, D. C. Montefiori, M. Rosati, B. K. Felber, G. N. Pavlakis, I. Mathiesen, Z. R. Israel, J. H. Eldridge and M. A. Egan. Effect of plasmid DNA vaccine design and in vivo electroporation on the resulting vaccine-specific immune responses in rhesus macaques. J. Virol. (2007) 81:5257-5269.

M. A. Egan, S. Megati, V. Roopchand, D. Garcia-Hand, A. Luckay, S.-Y. Chong, M. Rosati, B. K. Felber, G. N. Pavlakis, J. H. Eldridge, Z. R. Israel, M. K. Sidhu. Rational design of a plasmid DNA vaccine capable of eliciting cell-mediated immune responses to multiple HIV antigens in mice. Vaccine (2006) 24:4677-4687.

M. A. Egan, S. Megati, V. Roopchand, D. Garcia-Hand, A. Luckay, S.-Y. Chong, M. Rosati, B. K. Felber, G. N. Pavlakis, J. H. Eldridge, Z. R. Israel, M. K. Sidhu.  Rational design of a plasmid DNA vaccine capable of eliciting cell-mediated immune responses to multiple HIV antigens in mice. Vaccine, 24:4510-4523 (2006).

M. A. Egan, S-Y. Chong, S. Megati, D. C. Montefiori, N. F. Rose, M. Sidhu, J. Quiroz, E. B. Schadeck, G. Pavlakis, D. B. Weiner, J. K. Rose, Z. R. Israel. Priming with Plasmid DNAs Expressing IL-12 and SIV Gag Protein Enhances the Immunogenicity and Efficacy of an Experimental AIDS Vaccine Based on Recombinant Vesicular Stomatitis Virus. AIDS Res. Human Retroviruses, 21:629-643 (2005).

Genetic Adjuvants

Holechek SA, McAfee MS, Nieves LM, Guzman VP, Manhas K, Fouts T, Bagley K, Blattman JN. Retinaldehyde Dehydrogenase 2 as a Molecular Adjuvant for Enhancement of Mucosal Immunity During DNA Vaccination. Vaccine (2016) Nov 4;34(46):5629-5635.

Bagley KC, Lewis GK, Fouts TR. Adjuvant Activity of the Catalytic A1 Domain of Cholera Toxin for Retroviral Antigens Delivered by GeneGun. Clin Vaccine Immunol. (2011)18:922-30.

Bagley KC, Shata MT, Onyabe DY, DeVico AL, Fouts TR, Lewis GK, Hone DM. Immunogenicity of DNA vaccines that direct the coincident expression of the 120 kDa glycoprotein of human immunodeficiency virus and the catalytic domain of cholera toxin. Vaccine (2003) 21(23):3335-41.

Bagley KC, Abdelwahab SF, Tuskan RG, Fouts TR, Lewis GK. Pertussis toxin and the adenylate cyclase toxin from Bordetella pertussis activate human monocyte-derived dendritic cells and dominantly inhibit cytokine production through a cAMP-dependent pathway. J Leukoc Biol. (2002)72(5):962-9.

Bagley KC, Abdelwahab SF, Tuskan RG, Fouts TR, Lewis GK. Cholera toxin and heat-labile enterotoxin activate human monocyte-derived dendritic cells and dominantly inhibit cytokine production through a cyclic AMP-dependent pathway. Infect Immun. (2002) 70(10):5533-9.

S.Y. Chong, M. A. Egan, S. Megati, A. Masood, D. C. Montefiori, J. D. Boyer, J. Quiroz, M. Rosati, E. B. Schadeck, M. Sidhu, G. N. Pavlakis, D. B. Weiner, J. H. Eldridge, Z. R. Israel. A Comparative analysis of the adjuvant effects of plasmid IL-12 and IL-15 in SIVgag plasmid DNA immunized rhesus macaques. Vaccine (2007) 25:4967-4982.

E. B. Schadeck, M. Sidhu, M. A. Egan, S.-Y. Chong, P. Piacente, A. Masood, D. Garcia-Hand, S. Cappello, V. Roopchand, S. Megati, J. Quiroz, J. D. Boyer, B. K. Felber, G. N. Pavlakis, D. B. Weiner, J. H. Eldridge, Z. R. Israel. Plasmid encoded IL-12 functions as a DNA vaccine adjuvant and augments SIVgag-specific cell-mediated and humoral immune responses in Rhesus macaques. Vaccine (2006)24:4677-4687.

M. A. Kutzler, T. M. Robinson, M. A. Chattergoon, D. K. Choo, A. Y. Choo, P. Y. Choe, M. P. Ramanathan, R. Parkinson, S. Kudchodkar, Y. Tamura, M. Sidhu, V. Roopchand, J. J. Kim, G. N. Pavlakis, B. K. Felber, T. A. Waldman, J. D. Boyer, D. B. Weiner.  Co-immunization with an optimized IL-15 plasmid results in enhanced function and longevity of CD8 T cells that are partially independent of CD4 T cell help. J. Immunol. (2005) 175:112 – 123.

Boyer, JD., Robinson, TM., Kutzler, MA., Calarota, SA., Sidhu, MK., Muthumani, K., Lewis,M., Pavalakis, G., Felber, B., Weiner, DB. SIV DNA vaccine co-administered with IL-12 expression plasmid enhances CD8 SIV cellular immune responses in cynomolgus macaques. J. Med. Primatology (2005) 34:1-8.

Chatergoon, M.A., Saulino, V., Shames, J., Stein, J., Montaner, L.J., and Weiner, D.B. Co-immunization with plasmid IL-12 generates a strong T-cell memory response in mice. Vaccine (2004) 22:1744-1750.

Calarota, S.A., Otero, M., Hermanstayne, K., Lewis, M., Rosati, M., Felber, B.K., Pavlakis, G.N., Boyer, J.D., and Weiner, D.B. Use of interleukin 15 to enhance interferon-gamma production by antigen-specific stimulated lymphocytes from rhesus macaques. J. Immunol. Methods(2003) 279:55-67.