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

Leunda A, Baldo A, Goossens M, Huygen K, Herman P, Romano M - Vaccines (Basel) (2014)

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Amaya.Leunda@wiv-isp.be.

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.

No MeSH data available.


Related in: MedlinePlus

The risk assessment of a “contained use” activity. The risk assessment takes into consideration on one hand, the identification of biological hazards of the genetically modified or pathogenic organism and the determination of its risk group and on the other hand, the nature of the manipulations determining the probability of exposure to potential biological hazards. The risk assessment allows assigning a class of risk to the contained use activity and the implementation of the recommended containment level in order to protect public health and the environment.
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vaccines-02-00463-f001: The risk assessment of a “contained use” activity. The risk assessment takes into consideration on one hand, the identification of biological hazards of the genetically modified or pathogenic organism and the determination of its risk group and on the other hand, the nature of the manipulations determining the probability of exposure to potential biological hazards. The risk assessment allows assigning a class of risk to the contained use activity and the implementation of the recommended containment level in order to protect public health and the environment.

Mentions: During the pre-clinical stages of research and development of novel TB vaccines, a number of studies are performed involving handling pathogenic Mtb or the GMO-based vaccine candidate. These research activities are carried out in contained facilities with a set of containment measures in order to protect human health and the environment against an accidental exposure to Mtb or the GMO vaccine candidate. A case-by-case risk assessment of these activities is performed to estimate the probability of occurrence and the severity of adverse effects in order to adapt the containment measures (Figure 1). It should identify potentially harmful properties of the biological agent (pathogenic organism genetically modified or not) that is manipulated. The following properties have to be documented to conduct a proper risk assessment: the pathogenicity of the organism, the transmission mode, its infectious dose, its persistence and stability in the environment and the availability of effective prophylaxis or therapy against the disease. Concerning the risk assessment of a GMO, each element used towards the achievement of the genetic modification should be assessed: the recipient organism, the genetic material inserted, the vector and the donor organism. The final organism (genetically modified or not) is then classified into one of the four risk groups according to their relative hazards, RG 1 referring to micro-organisms that are proven non-pathogenic or are unlikely to cause disease (in healthy individuals) and RG 4 referring to micro-organisms highly transmissible that cause a fatal disease for which no treatment or prophylaxis is available [2]. The risk assessment takes also into account the characteristics of the operation performed with the organism that could influence the probability of exposure of workers, the general population and the environment: the scale of the operations (a production activity involving high volumes), the concentration of the organism and the type of manipulations involving the organism (creating infectious aerosols for example).


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

Leunda A, Baldo A, Goossens M, Huygen K, Herman P, Romano M - Vaccines (Basel) (2014)

The risk assessment of a “contained use” activity. The risk assessment takes into consideration on one hand, the identification of biological hazards of the genetically modified or pathogenic organism and the determination of its risk group and on the other hand, the nature of the manipulations determining the probability of exposure to potential biological hazards. The risk assessment allows assigning a class of risk to the contained use activity and the implementation of the recommended containment level in order to protect public health and the environment.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494264&req=5

vaccines-02-00463-f001: The risk assessment of a “contained use” activity. The risk assessment takes into consideration on one hand, the identification of biological hazards of the genetically modified or pathogenic organism and the determination of its risk group and on the other hand, the nature of the manipulations determining the probability of exposure to potential biological hazards. The risk assessment allows assigning a class of risk to the contained use activity and the implementation of the recommended containment level in order to protect public health and the environment.
Mentions: During the pre-clinical stages of research and development of novel TB vaccines, a number of studies are performed involving handling pathogenic Mtb or the GMO-based vaccine candidate. These research activities are carried out in contained facilities with a set of containment measures in order to protect human health and the environment against an accidental exposure to Mtb or the GMO vaccine candidate. A case-by-case risk assessment of these activities is performed to estimate the probability of occurrence and the severity of adverse effects in order to adapt the containment measures (Figure 1). It should identify potentially harmful properties of the biological agent (pathogenic organism genetically modified or not) that is manipulated. The following properties have to be documented to conduct a proper risk assessment: the pathogenicity of the organism, the transmission mode, its infectious dose, its persistence and stability in the environment and the availability of effective prophylaxis or therapy against the disease. Concerning the risk assessment of a GMO, each element used towards the achievement of the genetic modification should be assessed: the recipient organism, the genetic material inserted, the vector and the donor organism. The final organism (genetically modified or not) is then classified into one of the four risk groups according to their relative hazards, RG 1 referring to micro-organisms that are proven non-pathogenic or are unlikely to cause disease (in healthy individuals) and RG 4 referring to micro-organisms highly transmissible that cause a fatal disease for which no treatment or prophylaxis is available [2]. The risk assessment takes also into account the characteristics of the operation performed with the organism that could influence the probability of exposure of workers, the general population and the environment: the scale of the operations (a production activity involving high volumes), the concentration of the organism and the type of manipulations involving the organism (creating infectious aerosols for example).

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Amaya.Leunda@wiv-isp.be.

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.

No MeSH data available.


Related in: MedlinePlus