메뉴 건너뛰기




Volumn 391, Issue 10120, 2018, Pages 552-562

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

(90)  Gaudinski, Martin R a   Houser, Katherine V a   Morabito, Kaitlyn M a   Hu, Zonghui a   Yamshchikov, Galina a   Rothwell, Ro Shauna a   Berkowitz, Nina a   Mendoza, Floreliz a   Saunders, Jamie G a   Novik, Laura a   Hendel, Cynthia S a   Holman, LaSonji A a   Gordon, Ingelise J a   Cox, Josephine H a   Edupuganti, Srilatha b   McArthur, Monica A c   Rouphael, Nadine G b   Lyke, Kirsten E c   Cummings, Ginny E c   Sitar, Sandra a   more..

d NONE

Author keywords

[No Author keywords available]

Indexed keywords

DNA VACCINE; PLASMID VECTOR; UNCLASSIFIED DRUG; VIRUS ENVELOPE PROTEIN; VIRUS VACCINE; VRC 5283; VRC 5288; CYTOKINE; NEUTRALIZING ANTIBODY; VIRUS ANTIBODY;

EID: 85037039416     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)33105-7     Document Type: Article
Times cited : (244)

References (32)
  • 1
    • 84957917366 scopus 로고    scopus 로고
    • Zika virus in the Americas—yet another arbovirus threat
    • Fauci, AS, Morens, DM, Zika virus in the Americas—yet another arbovirus threat. N Engl J Med 374 (2016), 601–604.
    • (2016) N Engl J Med , vol.374 , pp. 601-604
    • Fauci, A.S.1    Morens, D.M.2
  • 3
    • 67149088928 scopus 로고    scopus 로고
    • Zika virus outbreak on Yap Island, Federated States of Micronesia
    • Duffy, MR, Chen, T-H, Hancock, WT, et al. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med 360 (2009), 2536–2543.
    • (2009) N Engl J Med , vol.360 , pp. 2536-2543
    • Duffy, M.R.1    Chen, T.-H.2    Hancock, W.T.3
  • 4
    • 84922276783 scopus 로고    scopus 로고
    • Notes on Zika virus—an emerging pathogen now present in the South Pacific
    • Derraik, JG, Slaney, D, Notes on Zika virus—an emerging pathogen now present in the South Pacific. Aust NZ J Public Health 39 (2015), 5–7.
    • (2015) Aust NZ J Public Health , vol.39 , pp. 5-7
    • Derraik, J.G.1    Slaney, D.2
  • 6
    • 84969559736 scopus 로고    scopus 로고
    • Evidence of sexual transmission of Zika virus
    • D'Ortenzio, E, Matheron, S, Yazdanpanah, Y, et al. Evidence of sexual transmission of Zika virus. N Engl J Med 374 (2016), 2195–2198.
    • (2016) N Engl J Med , vol.374 , pp. 2195-2198
    • D'Ortenzio, E.1    Matheron, S.2    Yazdanpanah, Y.3
  • 7
    • 84988328439 scopus 로고    scopus 로고
    • Evidence for transmission of Zika virus by platelet transfusion
    • Motta, IJ, Spencer, BR, Cordeiro da Silva, SG, et al. Evidence for transmission of Zika virus by platelet transfusion. N Engl J Med 375 (2016), 1101–1103.
    • (2016) N Engl J Med , vol.375 , pp. 1101-1103
    • Motta, I.J.1    Spencer, B.R.2    Cordeiro da Silva, S.G.3
  • 8
    • 84963743482 scopus 로고    scopus 로고
    • Survey of blood collection centers and implementation of guidance for prevention of transfusion-transmitted Zika virus infection—Puerto Rico, 2016
    • Vasquez, AM, Sapiano, MR, Basavaraju, SV, Kuehnert, MJ, Rivera-Garcia, B, Survey of blood collection centers and implementation of guidance for prevention of transfusion-transmitted Zika virus infection—Puerto Rico, 2016. MMWR Morb Mortal Wkly Rep 65 (2016), 375–378.
    • (2016) MMWR Morb Mortal Wkly Rep , vol.65 , pp. 375-378
    • Vasquez, A.M.1    Sapiano, M.R.2    Basavaraju, S.V.3    Kuehnert, M.J.4    Rivera-Garcia, B.5
  • 9
    • 85016623377 scopus 로고    scopus 로고
    • Zika virus transmission—region of the Americas, May 15, 2015–December 15, 2016
    • Ikejezie, J, Shapiro, CN, Kim, J, et al. Zika virus transmission—region of the Americas, May 15, 2015–December 15, 2016. MMWR Morb Mortal Wkly Rep 66 (2017), 329–334.
    • (2017) MMWR Morb Mortal Wkly Rep , vol.66 , pp. 329-334
    • Ikejezie, J.1    Shapiro, C.N.2    Kim, J.3
  • 10
    • 84959096835 scopus 로고    scopus 로고
    • Zika virus and microcephaly: why is this situation a PHEIC?
    • Heymann, DL, Hodgson, A, Sall, AA, et al. Zika virus and microcephaly: why is this situation a PHEIC?. Lancet 387 (2016), 719–721.
    • (2016) Lancet , vol.387 , pp. 719-721
    • Heymann, D.L.1    Hodgson, A.2    Sall, A.A.3
  • 11
    • 85010933967 scopus 로고    scopus 로고
    • Zika virus infection as a cause of congenital brain abnormalities and Guillain-Barré syndrome: systematic review
    • Krauer, F, Riesen, M, Reveiz, L, et al. Zika virus infection as a cause of congenital brain abnormalities and Guillain-Barré syndrome: systematic review. PLoS Med, 14, 2017, e1002203.
    • (2017) PLoS Med , vol.14 , pp. e1002203
    • Krauer, F.1    Riesen, M.2    Reveiz, L.3
  • 12
    • 85021149360 scopus 로고    scopus 로고
    • Infection-related microcephaly after the 2015 and 2016 Zika virus outbreaks in Brazil: a surveillance-based analysis
    • de Oliveira, WK, de Franca, GVA, Carmo, EH, Duncan, BB, de Souza Kuchenbecker, R, Schmidt, MI, Infection-related microcephaly after the 2015 and 2016 Zika virus outbreaks in Brazil: a surveillance-based analysis. Lancet 390 (2017), 861–870.
    • (2017) Lancet , vol.390 , pp. 861-870
    • de Oliveira, W.K.1    de Franca, G.V.A.2    Carmo, E.H.3    Duncan, B.B.4    de Souza Kuchenbecker, R.5    Schmidt, M.I.6
  • 13
    • 55749111036 scopus 로고    scopus 로고
    • 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, et al. A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a phase I clinical trial. Vaccine 26 (2008), 6338–6343.
    • (2008) Vaccine , vol.26 , pp. 6338-6343
    • Martin, J.E.1    Louder, M.K.2    Holman, L.A.3
  • 14
    • 33846909686 scopus 로고    scopus 로고
    • A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial
    • Martin, JE, Sullivan, NJ, Enama, ME, et al. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol 13 (2006), 1267–1277.
    • (2006) Clin Vaccine Immunol , vol.13 , pp. 1267-1277
    • Martin, J.E.1    Sullivan, N.J.2    Enama, M.E.3
  • 15
    • 78751572962 scopus 로고    scopus 로고
    • Evaluation of a prototype dengue-1 DNA vaccine in a phase 1 clinical trial
    • Beckett, CG, Tjaden, J, Burgess, T, et al. Evaluation of a prototype dengue-1 DNA vaccine in a phase 1 clinical trial. Vaccine 29 (2011), 960–968.
    • (2011) Vaccine , vol.29 , pp. 960-968
    • Beckett, C.G.1    Tjaden, J.2    Burgess, T.3
  • 16
    • 39149128276 scopus 로고    scopus 로고
    • A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial
    • Martin, JE, Pierson, TC, Hubka, S, et al. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis 196 (2007), 1732–1740.
    • (2007) J Infect Dis , vol.196 , pp. 1732-1740
    • Martin, J.E.1    Pierson, T.C.2    Hubka, S.3
  • 17
    • 81855182191 scopus 로고    scopus 로고
    • DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials
    • Ledgerwood, JE, Wei, CJ, Hu, Z, et al. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis 11 (2011), 916–924.
    • (2011) Lancet Infect Dis , vol.11 , pp. 916-924
    • Ledgerwood, J.E.1    Wei, C.J.2    Hu, Z.3
  • 18
    • 33744792063 scopus 로고    scopus 로고
    • Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, severe acute respiratory syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts
    • Sheets, RL, Stein, J, Manetz, TS, et al. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, severe acute respiratory syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Sci 91 (2006), 620–630.
    • (2006) Toxicol Sci , vol.91 , pp. 620-630
    • Sheets, R.L.1    Stein, J.2    Manetz, T.S.3
  • 19
    • 33845412550 scopus 로고    scopus 로고
    • Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine
    • Graham, BS, Koup, RA, Roederer, M, et al. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194 (2006), 1650–1660.
    • (2006) J Infect Dis , vol.194 , pp. 1650-1660
    • Graham, B.S.1    Koup, R.A.2    Roederer, M.3
  • 20
    • 0029162425 scopus 로고
    • Synthesis and secretion of recombinant tick-borne encephalitis virus protein E in soluble and particulate form
    • Allison, SL, Stadler, K, Mandl, CW, Kunz, C, Heinz, FX, Synthesis and secretion of recombinant tick-borne encephalitis virus protein E in soluble and particulate form. J Virol 69 (1995), 5816–5820.
    • (1995) J Virol , vol.69 , pp. 5816-5820
    • Allison, S.L.1    Stadler, K.2    Mandl, C.W.3    Kunz, C.4    Heinz, F.X.5
  • 21
    • 0035051928 scopus 로고    scopus 로고
    • West Nile virus recombinant DNA vaccine protects mouse and horse from virus challenge and expresses in vitro a noninfectious recombinant antigen that can be used in enzyme-linked immunosorbent assays
    • Davis, BS, Chang, GJ, Cropp, B, et al. West Nile virus recombinant DNA vaccine protects mouse and horse from virus challenge and expresses in vitro a noninfectious recombinant antigen that can be used in enzyme-linked immunosorbent assays. J Virol 75 (2001), 4040–4047.
    • (2001) J Virol , vol.75 , pp. 4040-4047
    • Davis, B.S.1    Chang, G.J.2    Cropp, B.3
  • 22
    • 84991706651 scopus 로고    scopus 로고
    • Rapid development of a DNA vaccine for Zika virus
    • Dowd, KA, Ko, SY, Morabito, KM, et al. Rapid development of a DNA vaccine for Zika virus. Science 354 (2016), 237–240.
    • (2016) Science , vol.354 , pp. 237-240
    • Dowd, K.A.1    Ko, S.Y.2    Morabito, K.M.3
  • 23
    • 31144445030 scopus 로고    scopus 로고
    • West Nile virus discrimintates between DC-SIGN and DC-SIGNR for cellular attachment and infection
    • Davis, CW, Nguyen, HY, Hanna, SL, Sánchez, MD, Doms, RW, Pierson, TC, West Nile virus discrimintates between DC-SIGN and DC-SIGNR for cellular attachment and infection. J Virol 80 (2006), 1290–1301.
    • (2006) J Virol , vol.80 , pp. 1290-1301
    • Davis, C.W.1    Nguyen, H.Y.2    Hanna, S.L.3    Sánchez, M.D.4    Doms, R.W.5    Pierson, T.C.6
  • 24
    • 84922473334 scopus 로고    scopus 로고
    • 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, et al. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis 211 (2015), 549–557.
    • (2015) J Infect Dis , vol.211 , pp. 549-557
    • Sarwar, U.N.1    Costner, P.2    Enama, M.E.3
  • 25
    • 85016959543 scopus 로고    scopus 로고
    • Vaccine development as a means to control dengue virus pathogenesis: do we know enough?
    • Pierson, TC, Diamond, MS, Vaccine development as a means to control dengue virus pathogenesis: do we know enough?. Ann Rev Virol 1 (2014), 375–398.
    • (2014) Ann Rev Virol , vol.1 , pp. 375-398
    • Pierson, T.C.1    Diamond, M.S.2
  • 26
    • 84976361840 scopus 로고    scopus 로고
    • Vaccine protection against Zika virus from Brazil
    • Larocca, RA, Abbink, P, Peron, JP, et al. Vaccine protection against Zika virus from Brazil. Nature 536 (2016), 474–478.
    • (2016) Nature , vol.536 , pp. 474-478
    • Larocca, R.A.1    Abbink, P.2    Peron, J.P.3
  • 27
    • 0024457636 scopus 로고
    • Dengue virus-specific cross-reactive CD8+ human cytotoxic T lymphocytes
    • Bukowski, JF, Kurane, I, Lai, CJ, Bray, M, Falgout, B, Ennis, FA, Dengue virus-specific cross-reactive CD8+ human cytotoxic T lymphocytes. J Virol 63 (1989), 5086–5091.
    • (1989) J Virol , vol.63 , pp. 5086-5091
    • Bukowski, J.F.1    Kurane, I.2    Lai, C.J.3    Bray, M.4    Falgout, B.5    Ennis, F.A.6
  • 28
    • 0038379214 scopus 로고    scopus 로고
    • Original antigenic sin and apoptosis in the pathogenesis of dengue hemorrhagic fever
    • Mongkolsapaya, J, Dejnirattisai, W, Xu, XN, et al. Original antigenic sin and apoptosis in the pathogenesis of dengue hemorrhagic fever. Nat Med 9 (2003), 921–927.
    • (2003) Nat Med , vol.9 , pp. 921-927
    • Mongkolsapaya, J.1    Dejnirattisai, W.2    Xu, X.N.3
  • 29
    • 84948706705 scopus 로고    scopus 로고
    • New insights into the immunopathology and control of dengue virus infection
    • Screaton, G, Mongkolsapaya, J, Yacoub, S, Roberts, C, New insights into the immunopathology and control of dengue virus infection. Nat Rev Immunol 15 (2015), 745–759.
    • (2015) Nat Rev Immunol , vol.15 , pp. 745-759
    • Screaton, G.1    Mongkolsapaya, J.2    Yacoub, S.3    Roberts, C.4
  • 30
    • 84954245170 scopus 로고    scopus 로고
    • Guiding dengue vaccine development using knowledge gained from the success of the yellow fever vaccine
    • Liang, H, Lee, M, Jin, X, Guiding dengue vaccine development using knowledge gained from the success of the yellow fever vaccine. Cell Mol Immunol 13 (2016), 36–46.
    • (2016) Cell Mol Immunol , vol.13 , pp. 36-46
    • Liang, H.1    Lee, M.2    Jin, X.3
  • 31
    • 84876002357 scopus 로고    scopus 로고
    • 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, et al. 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. PLoS One, 8, 2013, e59340.
    • (2013) PLoS One , vol.8 , pp. e59340
    • Graham, B.S.1    Enama, M.E.2    Nason, M.C.3
  • 32
    • 85115301430 scopus 로고    scopus 로고
    • Safety and immunogencity of an anti-Zika virus DNA vaccine—preliminary report
    • published online Oct 4.
    • Tebas, P, Roberts, CC, Muthumani, K, et al. Safety and immunogencity of an anti-Zika virus DNA vaccine—preliminary report. N Engl J Med, 2017 published online Oct 4. DOI:10.1056/NEJMoa1708120.
    • (2017) N Engl J Med
    • Tebas, P.1    Roberts, C.C.2    Muthumani, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.