How can controlled human infection models accelerate clinical development and policy pathways for vaccines against Shigella?

被引：22

作者：

Giersing, Birgitte K. ^{[1
]}

Porter, Chad K. ^{[2
]}

Kotloff, Karen ^{[3
,4
]}

Neels, Pieter ^{[5
]}

Cravioto, Alejandro ^{[6
]}

MacLennan, Calman A. ^{[7
]}

机构：

[1] WHO Headquarters, Dept Immunizat Vaccines & Biol, Initiat Vaccine Res, 20 Ave Appia, CH-1211 Geneva 27, Switzerland

[2] Naval Med Res Ctr, 503 Robert Grant Ave, Silver Spring, MD 20910 USA

[3] Univ Maryland, Sch Med, Dept Pediat, Baltimore, MD 21201 USA

[4] Univ Maryland, Sch Med, Ctr Vaccine Dev & Global Hlth, Baltimore, MD 21201 USA

[5] Int Alliance Biol Standardizat, Geneva, Switzerland

[6] Univ Nacl Autonoma Mexico, Fac Med, Ciudad De Mexico, Mexico

[7] Bill & Melinda Gates Fdn, Global Hlth, Enter & Diarrheal Dis, Seattle, WA USA

来源：

VACCINE | 2019年 / 37卷 / 34期

关键词：

Shigella; Challenge; Vaccine; Development; Policy; TOXOID CONJUGATE VACCINE; ORAL CHOLERA VACCINE; DOUBLE-BLIND; IMMUNOGENICITY; SAFETY; EFFICACY; VI; MULTICENTER; INFANTS; ADULTS;

D O I：

10.1016/j.vaccine.2019.03.036

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Controlled Human Infection Models (CHIMs) now exist for several infectious diseases. CHIMs offer significant insight into disease pathogenesis, as well the potential to rapidly test clinical proof-of-concept of vaccine candidates. The application of CHIMs to identify a correlate of protection that may reduce the sample size of, or obviate the need for clinical efficacy studies to achieve licensure is of considerable interest to vaccine developers and public health stakeholders. This topic was the subject of a workshop at the 2018 Vaccines Against Shigella and ETEC (VASE) conference, in the context of O-antigen-based Shigella vaccines. (C) 2019 The Authors. Published by Elsevier Ltd.

引用

页码：4778 / 4783

页数：6

共 37 条

[1]

[Anonymous], 2017, Wkly Epidemiol Rec, V92, P477

[2]

[Anonymous], 2010, Wkly Epidemiol Rec, V85, P117

[3]

[Anonymous], 2018, WEEKLY EPIDEMIOL REC, V93, P153

[4]

Baay MFD, 2018, HUMAN CHALLENGE TRIA

[5] Establishment of a Shigella sonnei human challenge model in Thailand [J].

Bodhidatta, Ladaporn ;

Pitisuttithum, Punnee ;

Chamnanchanant, Supat ;

Chang, Karen T. ;

Islam, Dilara ;

Bussaratid, Valai ;

Venkatesan, Malabi M. ;

Hale, Thomas L. ;

Mason, Carl J. .

VACCINE, 2012, 30 (49) :7040-7045

[6]

Chaignat CL, 2007, J HEALTH POPUL NUTR, V25, P244

[7] Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor [J].

Chen, Wilbur H. ;

Cohen, Mitchell B. ;

Kirkpatrick, Beth D. ;

Brady, Rebecca C. ;

Galloway, David ;

Gurwith, Marc ;

Hall, Robert H. ;

Kessler, Robert A. ;

Lock, Michael ;

Haney, Douglas ;

Lyon, Caroline E. ;

Pasetti, Marcela F. ;

Simon, Jakub K. ;

Szabo, Flora ;

Tennant, Sharon ;

Levine, Myron M. .

CLINICAL INFECTIOUS DISEASES, 2016, 62 (11) :1329-1335

[8] Double-blind vaccine-controlled randomised efficacy trial of an investigational Shigella sonnei conjugate vaccine in young adults [J].

Cohen, D ;

Ashkenazi, S ;

Green, MS ;

Gdalevich, M ;

Robin, G ;

Slepon, R ;

Yavzori, M ;

Orr, N ;

Block, C ;

Ashkenazi, I ;

Shemer, J ;

Taylor, DN ;

Hale, TL ;

Sadoff, JC ;

Pavliakova, D ;

Schneerson, R ;

Robbins, JB .

LANCET, 1997, 349 (9046) :155-159

[9]

Cohen D, 2017, VACC ENTERIC DIS POR

[10]

Colombara DV., 2016, The American Journal of Gastroenterology Supplements, V3, P4, DOI [DOI 10.1038/AJGSUP.2016.9, 10.1038/ajgsup.2016.9]

← 1 2 3 4 →