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Vaccines (Basel). 2014 Jun 16;2(2):463-99. doi: 10.3390/vaccines2020463.

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

Vaccines

Amaya Leunda, Aline Baldo, Martine Goossens, Kris Huygen, Philippe Herman, Marta Romano

Affiliations

  1. Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. [email protected].
  2. Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. [email protected].
  3. Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. [email protected].
  4. Immunology Unit, Scientific Institute of Public Health, 642 Engeland Street, Brussels 1180, Belgium. [email protected].
  5. Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. [email protected].
  6. Immunology Unit, Scientific Institute of Public Health, 642 Engeland Street, Brussels 1180, Belgium. [email protected].

PMID: 26344627 PMCID: PMC4494264 DOI: 10.3390/vaccines2020463

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: biosafety; clinical trial; genetically modified organism; risk assessment; tuberculosis; vaccine candidate

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