Scientific Opinion on field trials for bovine tuberculosis vaccination
2013; Wiley; Volume: 11; Issue: 12 Linguagem: Inglês
10.2903/j.efsa.2013.3475
ISSN1831-4732
Tópico(s)Viral gastroenteritis research and epidemiology
ResumoEFSA JournalVolume 11, Issue 12 3475 OpinionOpen Access Scientific Opinion on field trials for bovine tuberculosis vaccination EFSA Panel on Animal Health and Welfare (AHAW), EFSA Panel on Animal Health and Welfare (AHAW)Search for more papers by this author EFSA Panel on Animal Health and Welfare (AHAW), EFSA Panel on Animal Health and Welfare (AHAW)Search for more papers by this author First published: 11 December 2013 https://doi.org/10.2903/j.efsa.2013.3475Citations: 5 Panel members: Edith Authie, Charlotte Berg, Anette Bøtner, Howard Browman, Ilaria Capua, Aline De Koeijer, Klaus Depner, Mariano Domingo, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde, Preben Willeberg and Stéphan Zientara Correspondence: ahaw@efsa.europa.eu Acknowledgement: The Panel wishes to thank the members of the Working Group on bovine tuberculosis vaccination: Aline De Koeijer, Arjan Stegeman, Edith Authie, Caroline Guittre, Eamonn Gormley, Javier Bezos and the hearing experts Rowland Kao, Fabian Tibaldi, Glyn Hewinson and Rebecca Jones for the preparatory work on this scientific opinion and EFSA staff: Frank Verdonck, Ana Afonso, Jane Richardson and José Cortinas Abrahantes for the support provided to this scientific opinion. Adoption date: 27 November 2013 Published date: 11 December 2013 Question number: EFSA-Q-2013-00241 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract 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. References Aagaard C, Govaerts M, Okkels LM, Andersen P and Pollock JM, 2003. Genomic approach to identification of Mycobacterium bovis diagnostic antigens in cattle. Journal of Clinical Microbiology, 41, 3719– 3728. Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P and Pollock JM, 2006. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6–CFP10 mixture shows optimal sensitivity and specificity. Journal of Clinical Microbiology, 44, 4326– 4335. 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