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DOI10.1016/j.biologicals.2013.11.011
Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward
Isbrucker, Richard1; Arciniega, Juan2; McFarland, Richard2; Chapsal, Jean-Michel3; Xing, Dorothy4; Bache, Christina5; Nelson, Sue6; Costanzo, Angele7; Hoonakker, Marieke8; Castiaux, Amelie9; Halder, Marlies10; Casey, Warren11; Johnson, Nelson12; Jones, Brett12; Doelling, Vivian12; Sprankle, Cathy12; Rinckel, Lori12; Stokes, William11,12
发表日期2014-03-01
ISSN1045-1056
卷号42期号:2页码:114-122
英文摘要

Regulatory authorities require safety and potency testing prior to the release of each production lot of acellular pertussis (aP)-containing vaccines. Currently, the murine histamine sensitization test (HIST) is used to evaluate the presence of residual pertussis toxin in aP containing vaccines. However, the testing requires the use of a significant number of mice and results in unrelieved pain and distress. NICEATM, ICCVAM, their partners in the International Cooperation on Alternative Test Methods, and the International Working Group for Alternatives to HIST organized a workshop to discuss recent developments in alternative assays to the HIST, review data from an international collaborative study on non-animal alternative tests that might replace the HIST, and address the path toward global acceptance of this type of method. Currently, there are three potential alternative methods to HIST. Participants agreed that no single in vitro method was sufficiently developed for harmonized validation studies at this time. It is unlikely that any single in vitro method would be applicable to all aP vaccines without modification, due to differences between vaccines. Workshop participants recommended further optimization of cell-based assays under development. Participants agreed that the next international collaborative studies should commence in 2013 based on discussions during this workshop.


英文关键词Pertussis toxin;Acellular pertussis vaccines;Alternative methods;Safety;Biochemical assays;Cell-based assays
语种英语
WOS记录号WOS:000335202200008
来源期刊BIOLOGICALS
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61783
作者单位1.Hlth Canada, Biol & Genet Therapies Directorate, Ottawa, ON K1A 0K9, Canada;
2.US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA;
3.Sanofi Pasteur, Lyon, France;
4.Natl Inst Biol Stand & Controls, Div Bacteriol, S Mimms EN6 3QG, Herts, England;
5.Paul Ehrlich Inst, D-63225 Langen, Germany;
6.Sanofi Pasteur, Toronto, ON, Canada;
7.European Directorate Qual Med & Healthcare, Strasbourg, France;
8.Netherlands Vaccine Inst, NL-3721 MA Bilthoven, Netherlands;
9.GlaxoSmithKline, B-1330 Rixensart, Belgium;
10.Inst Hlth & Consumer Protect, European Commiss Joint Res Ctr, European Union Reference Lab Alternat Anim Testin, I-21027 Ispra, Varese, Italy;
11.Natl Inst Environm Hlth Sci, Natl Toxicol Program, Ctr Evaluat, Alternat Toxicol Methods Div,NIH, Res Triangle Pk, NC 27709 USA;
12.Integrated Lab Syst Inc, Morrisville, NC 27560 USA
推荐引用方式
GB/T 7714
Isbrucker, Richard,Arciniega, Juan,McFarland, Richard,et al. Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward[J]. 美国环保署,2014,42(2):114-122.
APA Isbrucker, Richard.,Arciniega, Juan.,McFarland, Richard.,Chapsal, Jean-Michel.,Xing, Dorothy.,...&Stokes, William.(2014).Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward.BIOLOGICALS,42(2),114-122.
MLA Isbrucker, Richard,et al."Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward".BIOLOGICALS 42.2(2014):114-122.
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