Design of vaccine efficacy trials during public health emergencies

被引:39
作者
Dean, Natalie E. [1 ]
Gsell, Pierre-Stephane [2 ]
Brookmeyer, Ron [3 ]
De Gruttola, Victor [4 ]
Donnelly, Christl A. [5 ,6 ]
Halloran, M. Elizabeth [7 ,8 ]
Jasseh, Momodou [9 ]
Nason, Martha [10 ]
Riveros, Ximena [2 ]
Watson, Conall H. [11 ]
Henao-Restrepo, Ana Maria [2 ]
Longini, Ira M. [1 ]
机构
[1] Univ Florida, Dept Biostat, Gainesville, FL 32611 USA
[2] WHO, Geneva, Switzerland
[3] Univ Calif Los Angeles, Dept Biostat, Los Angeles, CA USA
[4] Harvard Univ, Dept Biostat, Boston, MA 02115 USA
[5] Univ Oxford, Dept Stat, Oxford, England
[6] Imperial Coll London, MRC Ctr Global Infect Dis Anal, Sch Publ Hlth, Dept Infect Dis Epidemiol, London, England
[7] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1124 Columbia St, Seattle, WA 98104 USA
[8] Univ Washington, Dept Biostat, Seattle, WA 98195 USA
[9] Gambia London Sch Hyg & Trop Med, Med Res Council, Fajara, Gambia
[10] NIAID, Biostat Res Branch, Rockville, MD USA
[11] London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London, England
基金
英国医学研究理事会;
关键词
EBOLA-VIRUS DISEASE; RING VACCINATION; GUINEA;
D O I
10.1126/scitranslmed.aat0360
中图分类号
Q2 [细胞生物学];
学科分类号
071009 ; 090102 ;
摘要
Public health emergencies, such as an Ebola disease outbreak, provide a complex and challenging environment for the evaluation of candidate vaccines. Here, we outline the need for flexible and responsive vaccine trial designs to be used in public health emergencies, and we summarize recommendations for their use in this setting.
引用
收藏
页数:7
相关论文
共 40 条
[1]  
[Anonymous], R D BLUEPR LIST BLUE
[2]  
[Anonymous], 252783 BIORXIV
[3]  
[Anonymous], ZIKV WORKSH 1 2 JUN
[4]  
[Anonymous], R D BLUEPR C DEV NEW
[5]  
[Anonymous], INT CLIN RES EP RESP
[6]  
[Anonymous], HUM CHALL TRIALS VAC
[7]  
[Anonymous], CLIN TRIALS DESIGN O
[8]  
[Anonymous], 2011, STAT COMMUN INFECT D
[9]   Statistical power and validity of Ebola vaccine trials in Sierra Leone: a simulation study of trial design and analysis [J].
Bellan, Steven E. ;
Pulliam, Juliet R. C. ;
Pearson, Carl A. B. ;
Champredon, David ;
Fox, Spencer J. ;
Skrip, Laura ;
Galvani, Alison P. ;
Gambhir, Manoj ;
Lopman, Ben A. ;
Porco, Travis C. ;
Meyers, Lauren Ancel ;
Dushoff, Jonathan .
LANCET INFECTIOUS DISEASES, 2015, 15 (06) :703-710
[10]   CEPI-a new global R&D organisation for epidemic preparedness and response [J].
Brende, Borge ;
Farrar, Jeremy ;
Gashumba, Diane ;
Moedas, Carlos ;
Mundel, Trevor ;
Shiozaki, Yasuhisa ;
Vardhan, Harsh ;
Wanka, Johanna ;
Rottingen, John-Arne .
LANCET, 2017, 389 (10066) :233-235