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Items: 39

1.

Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial.

Carter C, Houser KV, Yamshchikov GV, Bellamy AR, May J, Enama ME, Sarwar U, Larkin B, Bailer RT, Koup R, Chen GL, Patel SM, Winokur P, Belshe R, Dekker CL, Graham BS, Ledgerwood JE; VRC 703 study team.

PLoS One. 2019 Sep 18;14(9):e0222178. doi: 10.1371/journal.pone.0222178. eCollection 2019.

2.

DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.

Houser KV, Yamshchikov GV, Bellamy AR, May J, Enama ME, Sarwar U, Larkin B, Bailer RT, Koup R, Paskel M, Subbarao K, Anderson E, Bernstein DI, Creech B, Keyserling H, Spearman P, Wright PF, Graham BS, Ledgerwood JE; VRC 702 study team.

PLoS One. 2018 Nov 2;13(11):e0206837. doi: 10.1371/journal.pone.0206837. eCollection 2018.

3.

An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial.

DeZure AD, Coates EE, Hu Z, Yamshchikov GV, Zephir KL, Enama ME, Plummer SH, Gordon IJ, Kaltovich F, Andrews S, McDermott A, Crank MC, Koup RA, Schwartz RM, Bailer RT, Sun X, Mascola JR, Tumpey TM, Graham BS, Ledgerwood JE.

NPJ Vaccines. 2017 Jun 1;2:15. doi: 10.1038/s41541-017-0016-6. eCollection 2017.

4.

Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection.

Lyke KE, Ishizuka AS, Berry AA, Chakravarty S, DeZure A, Enama ME, James ER, Billingsley PF, Gunasekera A, Manoj A, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Kc N, Murshedkar T, Mendoza FH, Gordon IJ, Zephir KL, Holman LA, Plummer SH, Hendel CS, Novik L, Costner PJ, Saunders JG, Berkowitz NM, Flynn BJ, Nason MC, Garver LS, Laurens MB, Plowe CV, Richie TL, Graham BS, Roederer M, Sim BK, Ledgerwood JE, Hoffman SL, Seder RA.

Proc Natl Acad Sci U S A. 2017 Mar 7;114(10):2711-2716. doi: 10.1073/pnas.1615324114. Epub 2017 Feb 21.

5.

Safety and Immunogenicity of a rAd35-EnvA Prototype HIV-1 Vaccine in Combination with rAd5-EnvA in Healthy Adults (VRC 012).

Crank MC, Wilson EM, Novik L, Enama ME, Hendel CS, Gu W, Nason MC, Bailer RT, Nabel GJ, McDermott AB, Mascola JR, Koup RA, Ledgerwood JE, Graham BS; VRC012 Study Team.

PLoS One. 2016 Nov 15;11(11):e0166393. doi: 10.1371/journal.pone.0166393. eCollection 2016.

6.

Corrigendum: Protection against malaria at 1 year and immune correlates following PfSPZ vaccination.

Ishizuka AS, Lyke KE, DeZure A, Berry AA, Richie TL, Mendoza FH, Enama ME, Gordon IJ, Chang LJ, Sarwar UN, Zephir KL, Holman LA, James ER, Billingsley PF, Gunasekera A, Chakravarty S, Manoj A, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, K C N, Murshedkar T, DeCederfelt H, Plummer SH, Hendel CS, Novik L, Costner PJ, Saunders JG, Laurens MB, Plowe CV, Flynn B, Whalen WR, Todd JP, Noor J, Rao S, Sierra-Davidson K, Lynn GM, Epstein JE, Kemp MA, Fahle GA, Mikolajczak SA, Fishbaugher M, Sack BK, Kappe SH, Davidson SA, Garver LS, Björkström NK, Nason MC, Graham BS, Roederer M, Sim BK, Hoffman SL, Ledgerwood JE, Seder RA; VRC 312 and VRC 314 Study Teams.

Nat Med. 2016 Jun 7;22(6):692. doi: 10.1038/nm0616-692c. No abstract available.

PMID:
27270781
7.

Protection against malaria at 1 year and immune correlates following PfSPZ vaccination.

Ishizuka AS, Lyke KE, DeZure A, Berry AA, Richie TL, Mendoza FH, Enama ME, Gordon IJ, Chang LJ, Sarwar UN, Zephir KL, Holman LA, James ER, Billingsley PF, Gunasekera A, Chakravarty S, Manoj A, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, K C N, Murshedkar T, DeCederfelt H, Plummer SH, Hendel CS, Novik L, Costner PJ, Saunders JG, Laurens MB, Plowe CV, Flynn B, Whalen WR, Todd JP, Noor J, Rao S, Sierra-Davidson K, Lynn GM, Epstein JE, Kemp MA, Fahle GA, Mikolajczak SA, Fishbaugher M, Sack BK, Kappe SH, Davidson SA, Garver LS, Björkström NK, Nason MC, Graham BS, Roederer M, Sim BK, Hoffman SL, Ledgerwood JE, Seder RA.

Nat Med. 2016 Jun;22(6):614-23. doi: 10.1038/nm.4110. Epub 2016 May 9. Erratum in: Nat Med. 2016 Jun 7;22(6):692.

PMID:
27158907
8.

Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection.

Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team.

Sci Transl Med. 2015 Dec 23;7(319):319ra206. doi: 10.1126/scitranslmed.aad5752.

PMID:
26702094
9.

Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults.

Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team.

Clin Exp Immunol. 2015 Dec;182(3):289-301. doi: 10.1111/cei.12692. Epub 2015 Sep 24.

10.

Phase I clinical evaluation of seasonal influenza hemagglutinin (HA) DNA vaccine prime followed by trivalent influenza inactivated vaccine (IIV3) boost.

Ledgerwood JE, Hu Z, Costner P, Yamshchikov G, Enama ME, Plummer S, Hendel CS, Holman L, Larkin B, Gordon I, Bailer RT, Poretz DM, Sarwar U, Kabadi A, Koup R, Mascola JR, Graham BS; VRC 307 and VRC 309 Study Teams.

Contemp Clin Trials. 2015 Sep;44:112-118. doi: 10.1016/j.cct.2015.08.006. Epub 2015 Aug 12.

11.

DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial.

Ledgerwood JE, Bellamy AR, Belshe R, Bernstein DI, Edupuganti S, Patel SM, Renehan P, Zajdowicz T, Schwartz R, Koup R, Bailer RT, Yamshchikov GV, Enama ME, Sarwar U, Larkin B, Graham BS; VRC 701 study team.

PLoS One. 2015 May 7;10(5):e0125914. doi: 10.1371/journal.pone.0125914. eCollection 2015.

12.

Phase 1 study of pandemic H1 DNA vaccine in healthy adults.

Crank MC, Gordon IJ, Yamshchikov GV, Sitar S, Hu Z, Enama ME, Holman LA, Bailer RT, Pearce MB, Koup RA, Mascola JR, Nabel GJ, Tumpey TM, Schwartz RM, Graham BS, Ledgerwood JE; VRC 308 Study Team.

PLoS One. 2015 Apr 17;10(4):e0123969. doi: 10.1371/journal.pone.0123969. eCollection 2015.

13.

Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial.

Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team.

Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.

PMID:
25540891
14.

Chimpanzee Adenovirus Vector Ebola Vaccine.

Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team.

N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.

15.

Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial.

Sarwar UN, Novik L, Enama ME, Plummer SA, Koup RA, Nason MC, Bailer RT, McDermott AB, Roederer M, Mascola JR, Ledgerwood JE, Graham BS; VRC 015 study team.

PLoS One. 2014 Sep 29;9(9):e106240. doi: 10.1371/journal.pone.0106240. eCollection 2014.

16.

Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial.

Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team.

J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

17.

Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial.

Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team.

Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.

PMID:
25132507
18.

Phase I randomized clinical trial of VRC DNA and rAd5 HIV-1 vaccine delivery by intramuscular (i.m.), subcutaneous (s.c.) and intradermal (i.d.) administration (VRC 011).

Enama ME, Ledgerwood JE, Novik L, Nason MC, Gordon IJ, Holman L, Bailer RT, Roederer M, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 011 Study Team.

PLoS One. 2014 Mar 12;9(3):e91366. doi: 10.1371/journal.pone.0091366. eCollection 2014.

19.

Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine.

Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB; HVTN 505 Study Team.

N Engl J Med. 2013 Nov 28;369(22):2083-92. doi: 10.1056/NEJMoa1310566. Epub 2013 Oct 7.

20.

Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine.

Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team.

Science. 2013 Sep 20;341(6152):1359-65. doi: 10.1126/science.1241800. Epub 2013 Aug 8.

21.

Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect.

Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team.

J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.

22.

DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.

Graham BS, Enama ME, Nason MC, Gordon IJ, Peel SA, Ledgerwood JE, Plummer SA, Mascola JR, Bailer RT, Roederer M, Koup RA, Nabel GJ; VRC 008 Study Team.

PLoS One. 2013;8(4):e59340. doi: 10.1371/journal.pone.0059340. Epub 2013 Apr 8.

23.

Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire.

Casazza JP, Bowman KA, Adzaku S, Smith EC, Enama ME, Bailer RT, Price DA, Gostick E, Gordon IJ, Ambrozak DR, Nason MC, Roederer M, Andrews CA, Maldarelli FM, Wiegand A, Kearney MF, Persaud D, Ziemniak C, Gottardo R, Ledgerwood JE, Graham BS, Koup RA; VRC 101 Study Team.

J Infect Dis. 2013 Jun 15;207(12):1829-40. doi: 10.1093/infdis/jit098. Epub 2013 Mar 12.

24.

Influenza virus h5 DNA vaccination is immunogenic by intramuscular and intradermal routes in humans.

Ledgerwood JE, Hu Z, Gordon IJ, Yamshchikov G, Enama ME, Plummer S, Bailer R, Pearce MB, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 304 and VRC 305 Study Teams.

Clin Vaccine Immunol. 2012 Nov;19(11):1792-7. doi: 10.1128/CVI.05663-11. Epub 2012 Sep 5.

25.

Randomization to standard and concise informed consent forms: development of evidence-based consent practices.

Enama ME, Hu Z, Gordon I, Costner P, Ledgerwood JE, Grady C; VRC 306 and 307 Consent Study Teams.

Contemp Clin Trials. 2012 Sep;33(5):895-902. Epub 2012 Apr 20.

26.

DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials.

Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team.

Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.

PMID:
21975270
27.

A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial.

Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team.

J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.

28.

A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults.

Ledgerwood JE, Costner P, Desai N, Holman L, Enama ME, Yamshchikov G, Mulangu S, Hu Z, Andrews CA, Sheets RA, Koup RA, Roederer M, Bailer R, Mascola JR, Pau MG, Sullivan NJ, Goudsmit J, Nabel GJ, Graham BS; VRC 205 Study Team.

Vaccine. 2010 Dec 16;29(2):304-13. doi: 10.1016/j.vaccine.2010.10.037. Epub 2010 Oct 27.

PMID:
21034824
29.

Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses.

Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team.

PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.

30.

A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial.

Martin JE, Louder MK, Holman LA, Gordon IJ, Enama ME, Larkin BD, Andrews CA, Vogel L, Koup RA, Roederer M, Bailer RT, Gomez PL, Nason M, Mascola JR, Nabel GJ, Graham BS; VRC 301 Study Team.

Vaccine. 2008 Nov 25;26(50):6338-43. doi: 10.1016/j.vaccine.2008.09.026. Epub 2008 Sep 26.

31.

A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial.

Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS.

J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650.

32.

Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine.

Catanzaro AT, Roederer M, Koup RA, Bailer RT, Enama ME, Nason MC, Martin JE, Rucker S, Andrews CA, Gomez PL, Mascola JR, Nabel GJ, Graham BS; VRC 007 Study Team.

Vaccine. 2007 May 16;25(20):4085-92. Epub 2007 Mar 7.

PMID:
17391815
33.

Safety and immunogenicity of a Gag-Pol candidate HIV-1 DNA vaccine administered by a needle-free device in HIV-1-seronegative subjects.

Tavel JA, Martin JE, Kelly GG, Enama ME, Shen JM, Gomez PL, Andrews CA, Koup RA, Bailer RT, Stein JA, Roederer M, Nabel GJ, Graham BS.

J Acquir Immune Defic Syndr. 2007 Apr 15;44(5):601-5.

34.

Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax challenge in vaccinia-naïve and vaccinia-immune individuals.

Parrino J, McCurdy LH, Larkin BD, Gordon IJ, Rucker SE, Enama ME, Koup RA, Roederer M, Bailer RT, Moodie Z, Gu L, Yan L, Graham BS; VRC 201/203 Study Team.

Vaccine. 2007 Feb 9;25(8):1513-25. Epub 2006 Nov 7.

35.

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine.

Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; Vaccine Research Center 004 Study Team.

J Infect Dis. 2006 Dec 15;194(12):1650-60. Epub 2006 Nov 8.

36.

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team.

J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8. Erratum in: J Infect Dis. 2009 Oct 15;200(8):1352-3.

37.

A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial.

Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, Bailer RT, Chakrabarti BK, Bailey MA, Gomez PL, Andrews CA, Moodie Z, Gu L, Stein JA, Nabel GJ, Graham BS.

Clin Vaccine Immunol. 2006 Nov;13(11):1267-77. Epub 2006 Sep 20.

38.

Early bactericidal activity of isoniazid in pulmonary tuberculosis. Optimization of methodology. The DATRI 008 Study Group.

Hafner R, Cohn JA, Wright DJ, Dunlap NE, Egorin MJ, Enama ME, Muth K, Peloquin CA, Mor N, Heifets LB.

Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):918-23.

PMID:
9310014

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