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Safety and Immunogenicity of Adenovirus 35 Tuberculosis Vaccine Candidate in Adults with Active or Previous Tuberculosis. A Randomized Trial.

van Zyl-Smit RN, Esmail A, Bateman ME, Dawson R, Goldin J, van Rikxoort E, Douoguih M, Pau MG, Sadoff JC, McClain JB, Snowden MA, Benko J, Hokey DA, Rutkowski KT, Graves A, Shepherd B, Ishmukhamedov S, Kagina BMN, Abel B, Hanekom WA, Scriba TJ, Bateman ED.

Am J Respir Crit Care Med. 2017 May 1;195(9):1171-1180. doi: 10.1164/rccm.201603-0654OC.


A nonhuman primate toxicology and immunogenicity study evaluating aerosol delivery of AERAS-402/Ad35 vaccine: Evidence for transient t cell responses in peripheral blood and robust sustained responses in the lungs.

Hokey DA, Wachholder R, Darrah PA, Bolton DL, Barouch DH, Hill K, Dheenadhayalan V, Schwander S, Godin CS, Douoguih M, Pau MG, Seder RA, Roederer M, Sadoff JC, Sizemore D.

Hum Vaccin Immunother. 2014;10(8):2199-210. doi: 10.4161/hv.29108.


The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses.

Kagina BM, Tameris MD, Geldenhuys H, Hatherill M, Abel B, Hussey GD, Scriba TJ, Mahomed H, Sadoff JC, Hanekom WA; 018-402 Clinical Lab study team, Mansoor N, Hughes J, de Kock M, Whatney W, Africa H, Krohn C, Veldsman A, Kany AL, Douoguih M, Pau MG, Hendriks J, McClainc B, Benko J, Snowden MA, Hokey DA.

Vaccine. 2014 Oct 14;32(45):5908-17. doi: 10.1016/j.vaccine.2014.09.001. Epub 2014 Sep 10.


Aerosol vaccination with AERAS-402 elicits robust cellular immune responses in the lungs of rhesus macaques but fails to protect against high-dose Mycobacterium tuberculosis challenge.

Darrah PA, Bolton DL, Lackner AA, Kaushal D, Aye PP, Mehra S, Blanchard JL, Didier PJ, Roy CJ, Rao SS, Hokey DA, Scanga CA, Sizemore DR, Sadoff JC, Roederer M, Seder RA.

J Immunol. 2014 Aug 15;193(4):1799-811. doi: 10.4049/jimmunol.1400676. Epub 2014 Jul 14.


Induction and regulation of T-cell immunity by the novel tuberculosis vaccine M72/AS01 in South African adults.

Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, Erasmus M, Makhethe L, Hughes EJ, Gelderbloem S, Bollaerts A, Bourguignon P, Cohen J, DemoitiƩ MA, Mettens P, Moris P, Sadoff JC, Hawkridge A, Hussey GD, Mahomed H, Ofori-Anyinam O, Hanekom WA.

Am J Respir Crit Care Med. 2013 Aug 15;188(4):492-502. doi: 10.1164/rccm.201208-1385OC.


Vaccine protection against acquisition of neutralization-resistant SIV challenges in rhesus monkeys.

Barouch DH, Liu J, Li H, Maxfield LF, Abbink P, Lynch DM, Iampietro MJ, SanMiguel A, Seaman MS, Ferrari G, Forthal DN, Ourmanov I, Hirsch VM, Carville A, Mansfield KG, Stablein D, Pau MG, Schuitemaker H, Sadoff JC, Billings EA, Rao M, Robb ML, Kim JH, Marovich MA, Goudsmit J, Michael NL.

Nature. 2012 Jan 4;482(7383):89-93. doi: 10.1038/nature10766.


Optimizing HIV-1-specific CD8+ T-cell induction by recombinant BCG in prime-boost regimens with heterologous viral vectors.

Hopkins R, Bridgeman A, Bourne C, Mbewe-Mvula A, Sadoff JC, Both GW, Joseph J, Fulkerson J, Hanke T.

Eur J Immunol. 2011 Dec;41(12):3542-52. doi: 10.1002/eji.201141962. Epub 2011 Oct 26.


Genetic immunization in the lung induces potent local and systemic immune responses.

Song K, Bolton DL, Wei CJ, Wilson RL, Camp JV, Bao S, Mattapallil JJ, Herzenberg LA, Herzenberg LA, Andrews CA, Sadoff JC, Goudsmit J, Pau MG, Seder RA, Kozlowski PA, Nabel GJ, Roederer M, Rao SS.

Proc Natl Acad Sci U S A. 2010 Dec 21;107(51):22213-8. doi: 10.1073/pnas.1015536108. Epub 2010 Dec 6. Erratum in: Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2629. Wei, Chih-Jen [added].


Safety and immunogenicity of novel recombinant BCG and modified vaccinia virus Ankara vaccines in neonate rhesus macaques.

Rosario M, Fulkerson J, Soneji S, Parker J, Im EJ, Borthwick N, Bridgeman A, Bourne C, Joseph J, Sadoff JC, Hanke T.

J Virol. 2010 Aug;84(15):7815-21. doi: 10.1128/JVI.00726-10. Epub 2010 May 19.


Update on research and development pipeline: tuberculosis vaccines.

Beresford B, Sadoff JC.

Clin Infect Dis. 2010 May 15;50 Suppl 3:S178-83. doi: 10.1086/651489. Review.


Novel recombinant Mycobacterium bovis BCG, ovine atadenovirus, and modified vaccinia virus Ankara vaccines combine to induce robust human immunodeficiency virus-specific CD4 and CD8 T-cell responses in rhesus macaques.

Rosario M, Hopkins R, Fulkerson J, Borthwick N, Quigley MF, Joseph J, Douek DC, Greenaway HY, Venturi V, Gostick E, Price DA, Both GW, Sadoff JC, Hanke T.

J Virol. 2010 Jun;84(12):5898-908. doi: 10.1128/JVI.02607-09. Epub 2010 Apr 7.


The novel tuberculosis vaccine, AERAS-402, induces robust and polyfunctional CD4+ and CD8+ T cells in adults.

Abel B, Tameris M, Mansoor N, Gelderbloem S, Hughes J, Abrahams D, Makhethe L, Erasmus M, de Kock M, van der Merwe L, Hawkridge A, Veldsman A, Hatherill M, Schirru G, Pau MG, Hendriks J, Weverling GJ, Goudsmit J, Sizemore D, McClain JB, Goetz M, Gearhart J, Mahomed H, Hussey GD, Sadoff JC, Hanekom WA.

Am J Respir Crit Care Med. 2010 Jun 15;181(12):1407-17. doi: 10.1164/rccm.200910-1484OC. Epub 2010 Feb 18.


Recombinant yellow fever vaccine virus 17D expressing simian immunodeficiency virus SIVmac239 gag induces SIV-specific CD8+ T-cell responses in rhesus macaques.

Bonaldo MC, Martins MA, Rudersdorf R, Mudd PA, Sacha JB, Piaskowski SM, Costa Neves PC, Veloso de Santana MG, Vojnov L, Capuano S 3rd, Rakasz EG, Wilson NA, Fulkerson J, Sadoff JC, Watkins DI, Galler R.

J Virol. 2010 Apr;84(7):3699-706. doi: 10.1128/JVI.02255-09. Epub 2010 Jan 20.


Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime-boost regimen.

Skeiky YA, Dietrich J, Lasco TM, Stagliano K, Dheenadhayalan V, Goetz MA, Cantarero L, Basaraba RJ, Bang P, Kromann I, McMclain JB, Sadoff JC, Andersen P.

Vaccine. 2010 Jan 22;28(4):1084-93. doi: 10.1016/j.vaccine.2009.10.114. Epub 2009 Nov 5.


Tuberculosis vaccine research: the impact of immunology.

Barker LF, Brennan MJ, Rosenstein PK, Sadoff JC.

Curr Opin Immunol. 2009 Jun;21(3):331-8. doi: 10.1016/j.coi.2009.05.017. Epub 2009 Jun 7. Review.


Novel recombinant BCG expressing perfringolysin O and the over-expression of key immunodominant antigens; pre-clinical characterization, safety and protection against challenge with Mycobacterium tuberculosis.

Sun R, Skeiky YA, Izzo A, Dheenadhayalan V, Imam Z, Penn E, Stagliano K, Haddock S, Mueller S, Fulkerson J, Scanga C, Grover A, Derrick SC, Morris S, Hone DM, Horwitz MA, Kaufmann SH, Sadoff JC.

Vaccine. 2009 Jul 16;27(33):4412-23. doi: 10.1016/j.vaccine.2009.05.048. Epub 2009 Jun 2.


A new recombinant bacille Calmette-GuƩrin vaccine safely induces significantly enhanced tuberculosis-specific immunity in human volunteers.

Hoft DF, Blazevic A, Abate G, Hanekom WA, Kaplan G, Soler JH, Weichold F, Geiter L, Sadoff JC, Horwitz MA.

J Infect Dis. 2008 Nov 15;198(10):1491-501. doi: 10.1086/592450.


Whole genome identification of Mycobacterium tuberculosis vaccine candidates by comprehensive data mining and bioinformatic analyses.

Zvi A, Ariel N, Fulkerson J, Sadoff JC, Shafferman A.

BMC Med Genomics. 2008 May 28;1:18. doi: 10.1186/1755-8794-1-18.


Correlates, surrogates, and vaccines.

Sadoff JC, Wittes J.

J Infect Dis. 2007 Nov 1;196(9):1279-81. Epub 2007 Oct 2. No abstract available.


Protective immune responses to a recombinant adenovirus type 35 tuberculosis vaccine in two mouse strains: CD4 and CD8 T-cell epitope mapping and role of gamma interferon.

Radosevic K, Wieland CW, Rodriguez A, Weverling GJ, Mintardjo R, Gillissen G, Vogels R, Skeiky YA, Hone DM, Sadoff JC, van der Poll T, Havenga M, Goudsmit J.

Infect Immun. 2007 Aug;75(8):4105-15. Epub 2007 May 25.

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