Scientific Opinion on field trials for bovine tuberculosis vaccination
Scientific Opinion on field trials for bovine tuberculosis vaccination
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DOI：
10.2903/j.efsa.2013.3475
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发表时间：
2013-12-01
期刊：
影响因子：
3.3
通讯作者：
Zientara, Stephan
中科院分区：
文献类型：
--
作者：
Authie, Edith;Berg, Charlotte;Zientara, Stephan
该意见提供了与田间试验设计相关的建议，以测试牛结核病（bTB）疫苗的性能，沿着检测接种动物中感染的试验（DIVA）。牛接种疫苗的目的是将疫苗与欧盟目前采用的控制措施结合使用，以帮助根除bTB。DIVA测试的理想现场试验将遵循OIE测试验证指南。任何与DIVA试验性能相关的理想试验设计偏离都应证明合理，并应考虑随后可能引入的偏倚。疫苗接种性能的理想田间试验设计应实施双盲随机试验方案，并考虑田间情况下的已知风险因素。与疫苗性能相关的任何偏离理想试验设计的情况也应得到证明，并应考虑随后可能引入的偏倚。本意见描述了田间试验设计中应考虑的相关风险因素和可能的混杂因素。候选疫苗的安全性在主管当局对疫苗药物的注册中得到保证。田间试验将需要满足这些要求，以证明在田间使用这种疫苗对公共卫生和环境都是安全的。关于这种特定疫苗的安全性的一些额外评论包括在本意见中。(C)欧洲食品安全局，2013年
The opinion provides advice relating to the design of field trials to test the performance of a vaccine for bovine tuberculosis (bTB), along with a test to Detect Infected among Vaccinated Animals (DIVA). The objective of cattle vaccination is to use the vaccine in combination with presently applied control measures within the EU as an aid towards bTB eradication. The ideal field trials for the DIVA test will follow the OIE guidelines for test validation. Any deviations from the ideal trial design in relation to DIVA test performance should be justified, and the bias that may subsequently be introduced should be accounted for. The ideal field trial design for vaccination performance should implement a double- blind randomised test scenario, and allow for known risk factors in the field situation. Any deviations from the ideal trial design in relation to vaccine performance should also be justified and bias that may subsequently be introduced should be accounted for. Relevant risk factors and possible confounders that should be taken into consideration in the design of field trials are described in this opinion. The safety of a candidate vaccine is guaranteed in the registration of a vaccine medication by a competent authority. The field trials will need to fulfil these requirements to prove that the use of this vaccine in the field is safe for both public health and the environment. Some additional remarks regarding the safety of this specific vaccine are included in this opinion. (C) European Food Safety Authority, 2013