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Items: 19

1.

Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study.

Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE; VRC 608 Study team.

Lancet. 2019 Mar 2;393(10174):889-898. doi: 10.1016/S0140-6736(19)30036-4. Epub 2019 Jan 24.

PMID:
30686586
2.

Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.

Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams.

Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.

3.

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.

4.

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.

5.

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
6.

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
7.

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.

8.

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.

9.

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.

10.

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.

11.

Colorectal screening: don't start too early.

Novik L.

J Fam Pract. 2010 Jun;59(6):313; author reply 313. No abstract available.

PMID:
20544061
12.

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.

13.

Hepatitis A seroprevalence in children and adults in Kiev City, Ukraine.

Moisseeva AV, Marichev IL, Biloschitchkay NA, Pavlenko KI, Novik LV, Kovinko LV, Lyabis OI, Houillon G, Rasuli AM.

J Viral Hepat. 2008 Oct;15 Suppl 2:43-6. doi: 10.1111/j.1365-2893.2008.01028.x.

PMID:
18837833
14.

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.

15.

[Effect of Cerebral on the immune system in experimental hemorrhagic stroke].

Arkad'ev VG, Novik LV, Pustovarov AIu, Maksimov IuN, Makarenko AN.

Eksp Klin Farmakol. 2002 Mar-Apr;65(2):20-3. Russian.

PMID:
12109285
16.

Recirculation reassessed: the impact of blood flow rate and the low-flow method reevaluated.

Sherman RA, Matera JJ, Novik L, Cody RP.

Am J Kidney Dis. 1994 Jun;23(6):846-8.

PMID:
8203367
17.

Gardnerella infection.

Novik L.

Am Fam Physician. 1984 Mar;29(3):55. No abstract available.

PMID:
6702552
18.

[Effect of prolonged administration of thyrocalcitonine on mineralization of regenerating bone after fracture].

Rolevich IV, Balaba TY, Briskin AL, Petruchuk IV, Novik LI.

Vopr Med Khim. 1975 Nov-Dec;21(6):647-52. Russian.

PMID:
1216780
19.

[Experimental study of the processes of mineralization of bone regenerate].

Rolevich IV, Petruchuk IV, Novik LI.

Ortop Travmatol Protez. 1974 Dec;(12):13-8. Russian. No abstract available.

PMID:
4459753

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