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Vaccines 2014, 2(2), 463-499; doi:10.3390/vaccines2020463
Review

Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations

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Received: 13 February 2014 / Revised: 24 April 2014 / Accepted: 6 May 2014 / Published: 16 June 2014
(This article belongs to the Special Issue Tuberculosis Vaccines)
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Abstract

Novel efficient vaccines are needed to control tuberculosis (TB), a major cause of morbidity and mortality worldwide. Several TB vaccine candidates are currently in clinical and preclinical development. They fall into two categories, the one of candidates designed as a replacement of the Bacille Calmette Guérin (BCG) to be administered to infants and the one of sub-unit vaccines designed as booster vaccines. The latter are designed as vaccines that will be administered to individuals already vaccinated with BCG (or in the future with a BCG replacement vaccine). In this review we provide up to date information on novel tuberculosis (TB) vaccines in development focusing on the risk assessment of candidates composed of genetically modified organisms (GMO) which are currently evaluated in clinical trials. Indeed, these vaccines administered to volunteers raise biosafety concerns with respect to human health and the environment that need to be assessed and managed.
Keywords: tuberculosis; vaccine candidate; clinical trial; genetically modified organism; risk assessment; biosafety tuberculosis; vaccine candidate; clinical trial; genetically modified organism; risk assessment; biosafety
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Leunda, A.; Baldo, A.; Goossens, M.; Huygen, K.; Herman, P.; Romano, M. Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations. Vaccines 2014, 2, 463-499.

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