메뉴 건너뛰기




Volumn 11, Issue 1, 2013, Pages

Implications of the licensure of a partially efficacious malaria vaccine on evaluating second-generation vaccines

Author keywords

Clinical trials; Malaria; Vaccine

Indexed keywords

MALARIA VACCINE; PLACEBO;

EID: 84887931701     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-11-232     Document Type: Article
Times cited : (10)

References (31)
  • 2
    • 84874499711 scopus 로고    scopus 로고
    • Geneva, Switzerland: WHO Press/World Health Organization, WHO
    • WHO World Malaria Report 2012 2012, 1-89. Geneva, Switzerland: WHO Press/World Health Organization, WHO.
    • (2012) World Malaria Report 2012 , pp. 1-89
  • 3
    • 84870871965 scopus 로고    scopus 로고
    • Malatia Vaccine Initiative
    • Malatia Vaccine Initiative Malaria Vaccine Technology Roadmap http://www.malariavaccine.org/files/Malaria_Vaccine_TRM_Final_000.pdf, Malatia Vaccine Initiative.
    • Malaria Vaccine Technology Roadmap
  • 8
    • 84855494087 scopus 로고    scopus 로고
    • A review of malaria vaccine clinical projects based on the WHO rainbow table
    • 10.1186/1475-2875-11-11, 3286401, 22230255
    • Schwartz L, Brown GV, Genton B, Moorthy VS. A review of malaria vaccine clinical projects based on the WHO rainbow table. Malar J 2012, 11:11. 10.1186/1475-2875-11-11, 3286401, 22230255.
    • (2012) Malar J , vol.11 , pp. 11
    • Schwartz, L.1    Brown, G.V.2    Genton, B.3    Moorthy, V.S.4
  • 10
    • 80054056017 scopus 로고    scopus 로고
    • Malaria vaccines and the new malaria agenda
    • 10.1111/j.1469-0691.2011.03612.x, 21883665
    • Greenwood BM, Targett GA. Malaria vaccines and the new malaria agenda. Clin Microbiol Infect 2011, 17:1600-1607. 10.1111/j.1469-0691.2011.03612.x, 21883665.
    • (2011) Clin Microbiol Infect , vol.17 , pp. 1600-1607
    • Greenwood, B.M.1    Targett, G.A.2
  • 11
    • 78751704914 scopus 로고    scopus 로고
    • Immunological correlates of protection for the RTS, S candidate malaria vaccine
    • 10.1016/S1473-3099(11)70001-9, 21237716
    • Greenwood B. Immunological correlates of protection for the RTS, S candidate malaria vaccine. Lancet Infect Dis 2011, 11:75-76. 10.1016/S1473-3099(11)70001-9, 21237716.
    • (2011) Lancet Infect Dis , vol.11 , pp. 75-76
    • Greenwood, B.1
  • 13
    • 77954762106 scopus 로고    scopus 로고
    • The RTS, S malaria vaccine
    • 10.1016/j.vaccine.2010.05.033, 20553771
    • Casares S, Brumeanu TD, Richie TL. The RTS, S malaria vaccine. Vaccine 2010, 28:4880-4894. 10.1016/j.vaccine.2010.05.033, 20553771.
    • (2010) Vaccine , vol.28 , pp. 4880-4894
    • Casares, S.1    Brumeanu, T.D.2    Richie, T.L.3
  • 14
    • 84871666296 scopus 로고    scopus 로고
    • A statistical interaction between circumsporozoite protein-specific T cell and antibody responses and risk of clinical malaria episodes following vaccination with RTS, S/AS01E
    • 10.1371/journal.pone.0052870, 3531328, 23300801
    • Ndungu FM, Mwacharo J, Kimani D, Kai O, Moris P, Jongert E, Vekemans J, Olotu A, Bejon P. A statistical interaction between circumsporozoite protein-specific T cell and antibody responses and risk of clinical malaria episodes following vaccination with RTS, S/AS01E. PLoS ONE 2012, 7:e52870. 10.1371/journal.pone.0052870, 3531328, 23300801.
    • (2012) PLoS ONE , vol.7
    • Ndungu, F.M.1    Mwacharo, J.2    Kimani, D.3    Kai, O.4    Moris, P.5    Jongert, E.6    Vekemans, J.7    Olotu, A.8    Bejon, P.9
  • 15
    • 0035893156 scopus 로고    scopus 로고
    • Challenges in the development, licensure, and use of combination vaccines
    • 10.1086/322560, 11767721
    • Postema AS, Myers MG, Breiman RF. Challenges in the development, licensure, and use of combination vaccines. Clin Infect Dis 2001, 33:S261-S266. 10.1086/322560, 11767721.
    • (2001) Clin Infect Dis , vol.33
    • Postema, A.S.1    Myers, M.G.2    Breiman, R.F.3
  • 16
    • 63249136766 scopus 로고    scopus 로고
    • Non-inferiority trials: determining whether alternative treatments are good enough
    • Scott IA. Non-inferiority trials: determining whether alternative treatments are good enough. Med J Aust 2009, 190:326-330.
    • (2009) Med J Aust , vol.190 , pp. 326-330
    • Scott, I.A.1
  • 17
    • 82555195187 scopus 로고    scopus 로고
    • A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial
    • 10.1371/journal.pmed.1001119, 3210754, 22087077, The Four Artemisinin-Based Combinations (4ABC) Study Group
    • The Four Artemisinin-Based Combinations (4ABC) Study Group A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. PLoS Med 2011, 8:e1001119. 10.1371/journal.pmed.1001119, 3210754, 22087077, The Four Artemisinin-Based Combinations (4ABC) Study Group.
    • (2011) PLoS Med , vol.8
  • 18
    • 77952303346 scopus 로고    scopus 로고
    • Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial
    • 10.1016/S0140-6736(10)60322-4, 20417857, Pyronaridine-artesunate Study Team
    • Tshefu AK, Gaye O, Kayentao K, Thompson R, Bhatt KM, Sesay SS, Bustos DG, Tjitra E, Bedu-Addo G, Borghini-Fuhrer I, Duparc S, Shin CS, Fleckenstein L, Pyronaridine-artesunate Study Team Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial. Lancet 2010, 375:1457-1467. 10.1016/S0140-6736(10)60322-4, 20417857, Pyronaridine-artesunate Study Team.
    • (2010) Lancet , vol.375 , pp. 1457-1467
    • Tshefu, A.K.1    Gaye, O.2    Kayentao, K.3    Thompson, R.4    Bhatt, K.M.5    Sesay, S.S.6    Bustos, D.G.7    Tjitra, E.8    Bedu-Addo, G.9    Borghini-Fuhrer, I.10    Duparc, S.11    Shin, C.S.12    Fleckenstein, L.13
  • 21
    • 65549167913 scopus 로고    scopus 로고
    • Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial
    • 10.1186/1475-2875-8-63, 2678145, 19366448
    • Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimdé A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J 2009, 8:63. 10.1186/1475-2875-8-63, 2678145, 19366448.
    • (2009) Malar J , vol.8 , pp. 63
    • Sagara, I.1    Rulisa, S.2    Mbacham, W.3    Adam, I.4    Sissoko, K.5    Maiga, H.6    Traore, O.B.7    Dara, N.8    Dicko, Y.T.9    Dicko, A.10    Djimdé, A.11    Jansen, F.H.12    Doumbo, O.K.13
  • 22
    • 63849233470 scopus 로고    scopus 로고
    • The efficacy and safety of a new fixed-dose combination of amodiaquine and artesunate in young African children with acute uncomplicated Plasmodium falciparum
    • 10.1186/1475-2875-8-48, 2662869, 19291301
    • Sirima SB, Tiono AB, Gansane A, Diarra A, Ouedraogo A, Konate AT, Kiechel JR, Morgan CC, Olliaro PL, Taylor WR. The efficacy and safety of a new fixed-dose combination of amodiaquine and artesunate in young African children with acute uncomplicated Plasmodium falciparum. Malar J 2009, 8:48. 10.1186/1475-2875-8-48, 2662869, 19291301.
    • (2009) Malar J , vol.8 , pp. 48
    • Sirima, S.B.1    Tiono, A.B.2    Gansane, A.3    Diarra, A.4    Ouedraogo, A.5    Konate, A.T.6    Kiechel, J.R.7    Morgan, C.C.8    Olliaro, P.L.9    Taylor, W.R.10
  • 23
    • 70349423602 scopus 로고    scopus 로고
    • Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine
    • 10.1086/605474, 19656069
    • Briand V, Bottero J, Noël H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis 2009, 200:991-1001. 10.1086/605474, 19656069.
    • (2009) J Infect Dis , vol.200 , pp. 991-1001
    • Briand, V.1    Bottero, J.2    Noël, H.3    Masse, V.4    Cordel, H.5    Guerra, J.6    Kossou, H.7    Fayomi, B.8    Ayemonna, P.9    Fievet, N.10    Massougbodji, A.11    Cot, M.12
  • 24
    • 0037056016 scopus 로고    scopus 로고
    • Sample size determination for phase II studies of new vaccines
    • 10.1016/S0264-410X(02)00317-1, 12213406
    • Rao MR, Blackwelder WC, Troendle JF, Naficy AB, Clemens JD. Sample size determination for phase II studies of new vaccines. Vaccine 2002, 20:3364-3369. 10.1016/S0264-410X(02)00317-1, 12213406.
    • (2002) Vaccine , vol.20 , pp. 3364-3369
    • Rao, M.R.1    Blackwelder, W.C.2    Troendle, J.F.3    Naficy, A.B.4    Clemens, J.D.5
  • 25
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement
    • 10.1001/jama.295.10.1152, 16522836
    • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006, 295:1152-1160. 10.1001/jama.295.10.1152, 16522836.
    • (2006) JAMA , vol.295 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3    Pocock, S.J.4    Evans, S.J.5
  • 27
    • 34249107535 scopus 로고    scopus 로고
    • Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation
    • 10.1016/j.vaccine.2007.01.085, 17577487
    • Moorthy V, Reed Z, Smith PG. Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. Vaccine 2007, 25:5115-5123. 10.1016/j.vaccine.2007.01.085, 17577487.
    • (2007) Vaccine , vol.25 , pp. 5115-5123
    • Moorthy, V.1    Reed, Z.2    Smith, P.G.3
  • 29
    • 79961108687 scopus 로고    scopus 로고
    • Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children
    • 10.1186/1475-2875-10-222, 3167766, 21816030
    • Lievens M, Aponte JJ, Williamson J, Mmbando B, Mohamed A, Bejon P, Leach A. Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children. Malar J 2011, 10:222. 10.1186/1475-2875-10-222, 3167766, 21816030.
    • (2011) Malar J , vol.10 , pp. 222
    • Lievens, M.1    Aponte, J.J.2    Williamson, J.3    Mmbando, B.4    Mohamed, A.5    Bejon, P.6    Leach, A.7
  • 30
    • 83755173307 scopus 로고    scopus 로고
    • What is the efficacy of the RTS, S malaria vaccine?
    • Duncan CJ, Hill AV. What is the efficacy of the RTS, S malaria vaccine?. BMJ Clin Res Ed 2011, 343:d7728.
    • (2011) BMJ Clin Res Ed , vol.343
    • Duncan, C.J.1    Hill, A.V.2
  • 31
    • 0030045041 scopus 로고    scopus 로고
    • Evaluating new vaccines for developing countries. Efficacy or effectiveness?
    • 10.1001/jama.1996.03530290060038, 8569019
    • Clemens J, Brenner R, Rao M, Tafari N, Lowe C. Evaluating new vaccines for developing countries. Efficacy or effectiveness?. JAMA 1996, 275:390-397. 10.1001/jama.1996.03530290060038, 8569019.
    • (1996) JAMA , vol.275 , pp. 390-397
    • Clemens, J.1    Brenner, R.2    Rao, M.3    Tafari, N.4    Lowe, C.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.