메뉴 건너뛰기




Volumn 14, Issue 9, 2018, Pages 2158-2162

Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine

Author keywords

antibody dependent enhancement; dengue; serious adverse event; severe dengue; vaccine

Indexed keywords

DENGUE VACCINE; LIVE VACCINE; RECOMBINANT VACCINE;

EID: 85046028109     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.1080/21645515.2018.1445448     Document Type: Note
Times cited : (58)

References (31)
  • 2
    • 84942434252 scopus 로고    scopus 로고
    • Addendum to report of the Global Advisory Committee on Vaccine Safety, 10–11 June 2015. Safety of CYD-TDV dengue vaccine
    • WHO. Addendum to report of the Global Advisory Committee on Vaccine Safety, 10–11 June 2015. Safety of CYD-TDV dengue vaccine. Weekly Epidemiological Record. 2015;90:421–32
    • (2015) Weekly Epidemiological Record. , vol.90 , pp. 421-432
  • 3
    • 78649376681 scopus 로고    scopus 로고
    • Guidelines for the clinical evaluation of dengue vaccines in endemic areas
    • Geneva, Switzerland: World Health Organization,. In:, ed
    • WHO. Guidelines for the clinical evaluation of dengue vaccines in endemic areas. In: Department of Immunization VaB, ed. Geneva, Switzerland: World Health Organization; 2008:441
    • (2008) Department of Immunization VaB , pp. 441
  • 4
    • 84973521591 scopus 로고    scopus 로고
    • Meeting of the Strategic Advisory Group of Experts on Immunization, April 2016, conclusions and recommendations
    • 27236868. PMID
    • WHO. Meeting of the Strategic Advisory Group of Experts on Immunization, April 2016, conclusions and recommendations. Weekly Epidemiological Record. 2016;91:265–84. PMID:27236868
    • (2016) Weekly Epidemiological Record. , vol.91 , pp. 265-284
  • 5
    • 85011600837 scopus 로고    scopus 로고
    • Dengue vaccine: WHO position paper, July 2016–recommendations
    • 28185744. ,. PMID
    • WHO. Dengue vaccine: WHO position paper, July 2016–recommendations. Vaccine. 2017;35:1200–1. doi:10.1016/j.vaccine.2016.10.070. PMID:28185744
    • (2017) Vaccine. , vol.35 , pp. 1200-1201
  • 6
    • 85054485877 scopus 로고    scopus 로고
    • Updated Questions and Answers related to the dengue vaccine Dengvaxia® and its use. Published 22 December 2017
    • Geneva: WHO,. In:, ed.,. Available from
    • WHO. Updated Questions and Answers related to the dengue vaccine Dengvaxia® and its use. Published 22 December 2017. In: Immunization VaB, ed. Geneva: WHO; 2017. Available from: http://www.who.int/immunization/diseases/dengue/q_and_a_dengue_vaccine_dengvaxia_use/en/
    • (2017) Immunization VaB
  • 7
    • 84960349690 scopus 로고    scopus 로고
    • Protective and immunological behavior of chimeric yellow fever dengue vaccine
    • 26873054. ,. PMID
    • Halstead SB, Russell PK. Protective and immunological behavior of chimeric yellow fever dengue vaccine. Vaccine. 2016;34:1643–7. doi:10.1016/j.vaccine.2016.02.004. PMID:26873054
    • (2016) Vaccine. , vol.34 , pp. 1643-1647
    • Halstead, S.B.1    Russell, P.K.2
  • 8
    • 84990047113 scopus 로고    scopus 로고
    • Licensed Dengue Vaccine: Public Health Conundrum and Scientific Challenge
    • 27352870. ,. PMID
    • Halstead SB. Licensed Dengue Vaccine: Public Health Conundrum and Scientific Challenge. Am J Trop Med Hyg. 2016;95:741–5. doi:10.4269/ajtmh.16-0222. PMID:27352870
    • (2016) Am J Trop Med Hyg. , vol.95 , pp. 741-745
    • Halstead, S.B.1
  • 9
    • 84988699044 scopus 로고    scopus 로고
    • Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines
    • 27513928,. ,. PMID
    • Russell PK, Halstead SB. Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines. PLoS Negl Trop Dis. 2016;10:e0004854. doi:10.1371/journal.pntd.0004854. PMID:27513928
    • (2016) PLoS Negl Trop Dis. , vol.10 , pp. e0004854
    • Russell, P.K.1    Halstead, S.B.2
  • 11
    • 84868211668 scopus 로고    scopus 로고
    • Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial
    • 22975340, et al. ,. PMID
    • Sabchareon A, Wallace D, Sirivichayakul C, Limkittikul K, Chanthavanich P, Suvannadabba S, Jiwariyavej V, Dulyachai W, Pengsaa K, Wartel TA, et al. Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Lancet. 2012;380:1559–67. doi:10.1016/S0140-6736(12)61428-7. PMID:22975340
    • (2012) Lancet. , vol.380 , pp. 1559-1567
    • Sabchareon, A.1    Wallace, D.2    Sirivichayakul, C.3    Limkittikul, K.4    Chanthavanich, P.5    Suvannadabba, S.6    Jiwariyavej, V.7    Dulyachai, W.8    Pengsaa, K.9    Wartel, T.A.10
  • 12
    • 84908160975 scopus 로고    scopus 로고
    • Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial
    • 25018116, et al. ,. PMID
    • Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, Luong CQ, Rusmil K, Wirawan DN, Nallusamy R, et al. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet. 2014;384:1358–65. doi:10.1016/S0140-6736(14)61060-6. PMID:25018116
    • (2014) Lancet. , vol.384 , pp. 1358-1365
    • Capeding, M.R.1    Tran, N.H.2    Hadinegoro, S.R.3    Ismail, H.I.4    Chotpitayasunondh, T.5    Chua, M.N.6    Luong, C.Q.7    Rusmil, K.8    Wirawan, D.N.9    Nallusamy, R.10
  • 14
    • 84960334283 scopus 로고    scopus 로고
    • Estimation of parameters related to vaccine efficacy and dengue transmission from two large phase III studies
    • 26614588. ,. PMID
    • Coudeville L, Baurin N, Vergu E. Estimation of parameters related to vaccine efficacy and dengue transmission from two large phase III studies. Vaccine. 2016;34:6417–25. doi:10.1016/j.vaccine.2015.11.023. PMID:26614588
    • (2016) Vaccine. , vol.34 , pp. 6417-6425
    • Coudeville, L.1    Baurin, N.2    Vergu, E.3
  • 16
    • 0642287817 scopus 로고    scopus 로고
    • Neutralization and antibody dependent enhancement of dengue viruses
    • Halstead SB. Neutralization and antibody dependent enhancement of dengue viruses Adv Virus Research. 2003;60:421–67. doi:10.1016/S0065-3527(03)60011-4
    • (2003) Adv Virus Research. , vol.60 , pp. 421-467
    • Halstead, S.B.1
  • 18
    • 33846929417 scopus 로고    scopus 로고
    • Global Advisory Committee on Vaccine Safety, 6–7 December 2017
    • WHO. Global Advisory Committee on Vaccine Safety, 6–7 December 2017. Weekly Epidemiological Record. 2018;3:18–30
    • (2018) Weekly Epidemiological Record. , vol.3 , pp. 18-30
  • 20
    • 84980337096 scopus 로고    scopus 로고
    • Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials
    • 27459266,. ,. PMID
    • Harenberg A, de Montfort A, Jantet-Blaudez F, Bonaparte M, Boudet F, Saville M, Jackson N, Guy B. Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials. PLoS Negl Trop Dis. 2016;10:e0004830. doi:10.1371/journal.pntd.0004830. PMID:27459266
    • (2016) PLoS Negl Trop Dis. , vol.10 , pp. e0004830
    • Harenberg, A.1    de Montfort, A.2    Jantet-Blaudez, F.3    Bonaparte, M.4    Boudet, F.5    Saville, M.6    Jackson, N.7    Guy, B.8
  • 21
    • 84994141295 scopus 로고    scopus 로고
    • Tetravalent Dengue Vaccine Reduces Symptomatic and Asymptomatic Dengue Virus Infections in Healthy Children and Adolescents Aged 2–16 Years in Asia and Latin America
    • 27418050. ,. PMID
    • Olivera-Botello G, Coudeville L, Fanouillere K, Guy B, Chambonneau L, Noriega F, Jackson N, CYD-TDV Vaccine Trial Group. Tetravalent Dengue Vaccine Reduces Symptomatic and Asymptomatic Dengue Virus Infections in Healthy Children and Adolescents Aged 2–16 Years in Asia and Latin America. J Infect Dis. 2016;214:994–1000. doi:10.1093/infdis/jiw297. PMID:27418050
    • (2016) J Infect Dis. , vol.214 , pp. 994-1000
    • Olivera-Botello, G.1    Coudeville, L.2    Fanouillere, K.3    Guy, B.4    Chambonneau, L.5    Noriega, F.6    Jackson, N.7
  • 22
    • 85019354473 scopus 로고    scopus 로고
    • Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?
    • 28528764. ,. PMID
    • Gessner BD, Halsey N. Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence? Vaccine. 2017;35:3452–6. doi:10.1016/j.vaccine.2017.05.003. PMID:28528764
    • (2017) Vaccine. , vol.35 , pp. 3452-3456
    • Gessner, B.D.1    Halsey, N.2
  • 23
    • 84951568741 scopus 로고    scopus 로고
    • Dengue vaccine: hypotheses to understand CYD-TDV-induced protection
    • 26639777. ,. PMID
    • Guy B, Jackson N. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection. Nat Rev Microbiol. 2016;14:45–54. doi:10.1038/nrmicro.2015.2. PMID:26639777
    • (2016) Nat Rev Microbiol. , vol.14 , pp. 45-54
    • Guy, B.1    Jackson, N.2
  • 24
    • 84989790877 scopus 로고    scopus 로고
    • Dengue vaccine: WHO position paper–July 2016
    • 27476189. PMID
    • WHO. Dengue vaccine: WHO position paper–July 2016. Weekly Epidemiological Record. 2016;91:349–64. PMID:27476189
    • (2016) Weekly Epidemiological Record. , vol.91 , pp. 349-364
  • 25
    • 84999670040 scopus 로고    scopus 로고
    • The Long-Term Safety, Public Health Impact, and Cost-Effectiveness of Routine Vaccination with a Recombinant, Live-Attenuated Dengue Vaccine (Dengvaxia): A Model Comparison Study
    • 27898668, et al.,. ,. PMID
    • Flasche S, Jit M, Rodriguez-Barraquer I, Coudeville L, Recker M, Koelle K, Milne G, Hladish TJ, Perkins TA, Cummings DA, et al. The Long-Term Safety, Public Health Impact, and Cost-Effectiveness of Routine Vaccination with a Recombinant, Live-Attenuated Dengue Vaccine (Dengvaxia): A Model Comparison Study. PLoS Med. 2016;13:e1002181. doi:10.1371/journal.pmed.1002181. PMID:27898668
    • (2016) PLoS Med. , vol.13 , pp. e1002181
    • Flasche, S.1    Jit, M.2    Rodriguez-Barraquer, I.3    Coudeville, L.4    Recker, M.5    Koelle, K.6    Milne, G.7    Hladish, T.J.8    Perkins, T.A.9    Cummings, D.A.10
  • 26
    • 85054503430 scopus 로고    scopus 로고
    • WHO, Geneva
    • Global Vaccine Safety Blueprint. WHO/IVB/12.07. WHO, Geneva, 2012. pp 38
    • (2012) WHO/IVB/12.07 , pp. 38
  • 27
    • 85054488321 scopus 로고    scopus 로고
    • Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated). Geneva: WHO Technical Report Series, 2011. Annex 2
    • Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated). Geneva: WHO Technical Report Series, 2011. Annex 2 2011
    • (2011)
  • 28
    • 47149086769 scopus 로고    scopus 로고
    • “Guidelines for the clinical evaluation of dengue vaccines in endemic areas”: Summary of a World Health Organization Technical Consultation
    • 18597906. ,. PMID
    • Edelman R, Hombach J. “Guidelines for the clinical evaluation of dengue vaccines in endemic areas”: Summary of a World Health Organization Technical Consultation. Vaccine. 2008;26:4113–9. doi:10.1016/j.vaccine.2008.05.058. PMID:18597906
    • (2008) Vaccine. , vol.26 , pp. 4113-4119
    • Edelman, R.1    Hombach, J.2
  • 29
    • 84999770048 scopus 로고    scopus 로고
    • Critique of World Health Organization Recommendation of a Dengue Vaccine
    • 27496975. ,. PMID
    • Halstead SB. Critique of World Health Organization Recommendation of a Dengue Vaccine. J Infect Dis. 2016;214:1793–5. doi:10.1093/infdis/jiw340. PMID:27496975
    • (2016) J Infect Dis. , vol.214 , pp. 1793-1795
    • Halstead, S.B.1
  • 30
    • 85015991736 scopus 로고    scopus 로고
    • Population perspectives and WHO recommendations for CYD-TDV dengue vaccine
    • 26747708,. ,. PMID
    • Wilder-Smith A, Vannice KS, Hombach J, Farrar J, Nolan T. Population perspectives and WHO recommendations for CYD-TDV dengue vaccine. J Infect Dis. 2016. doi:10.1093/infdis/jiw341. PMID:26747708
    • (2016) J Infect Dis.
    • Wilder-Smith, A.1    Vannice, K.S.2    Hombach, J.3    Farrar, J.4    Nolan, T.5
  • 31
    • 85016015412 scopus 로고    scopus 로고
    • Dengue Vaccine Efficacy: Not a Zero Sum Game
    • 27694632,. ,. PMID
    • Halstead SB. Dengue Vaccine Efficacy: Not a Zero Sum Game. J Infect Dis. 2016;214:2014. doi:10.1093/infdis/jiw458. PMID:27694632
    • (2016) J Infect Dis. , vol.214 , pp. 2014
    • Halstead, S.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.