The vaccines that are currently used for the vaccination of tuberculosis is a live attenuated vaccine and it requires booster dose because of the short-lived activity and memory of antibodies produced (Counoupas et al. 2018). To overcome these the recent innovation is the formation of vaccine which by the use of recombinant technology. From the use of conventional technology, it was seen that there is overexpression of Ag85B which was produced when the vaccination was administered and the only strain that produced the antigen expression was rBCG (Triccas and Counoupas 2016). The protein which is responsible for the overexpression of the antigen is cultivated in lab animals which are grown under controlled conditions.
The idea behind the recombinant technology is that t instead of administration of live attenuated organisms which are responsible for the development of the disease in humans only the antigenic portion is extracted from the organism and when this is administered it can form only the antibodies (Bachtarzi and Farries 2019). The antibodies formed as a result is the one which will have strong memory as they will be formed only against the antigen and they will not fight against the live attenuated organisms. From previous research, the protein has been identified by the use of DNA encoding responsible for the causation of tuberculosis in humans.
There are 16 genomic regions of differentiation RD1–RD16, plus nRD18 and during attenuation, RD-1 is lost in strains of BCG vaccines and it encodes for the T-lymphocyte epitopes such as ESAT-6, CFP-10, Rv3873, and PPE protein (Da Costa et al. 2014). RD1 encodes Mpt64 and CFP-21 while RD14 is responsible morphology of colony and cell membrane formation (Oliveira et al. 2017). The markers which are identified in the T-cells responsible for the memory formation are CD45RAhi, CD45ROneg, and CCR7neg, while for central memory T-cell populations it is CD45RAhi/low, CD45ROneg, and CCR7pos (Da Costa et al. 2014; Bhattacharya et al. 2014).
The aim of the recombinant vaccine is to extract the best bits of the DNA or proteins from the strains of the mycobacterium tuberculosis so as to eliminate the bacterial vector which is causative of the disease and just get the immunological reaction (Horwitz and Jia 2018). Before the product can be commercialized it is important that patency is obtained for the product which can be obtained from national or international bodies.
The production will involve a lot of steps and procedures the first step is to obtain the protein from the microorganism and then cultivate ex-vivo by polymerization followed by checking of the efficacy in lab animals that have the disease process similar to that of humans. Further, it is tested based on phases of the clinical trial starting with volunteer and ending in commercial administration of the vaccine (Hoft et al. 2016). The vaccine needs to be produced in batches where first the protein is extracted and there is the deletion of the portions not required and then by PCR technique, the quantity can be increased lastly it is packaged for use.
Bachtarzi, H. and Farries, T. 2019. The Genetically Modified Organism Medicinal Framework in Europe, United States, and Japan: Underlying Scientific Principles and Considerations Toward the Development of Gene Therapy and Genetically Modified Cell-Based Products. Human Gene Therapy Clinical Development, 30(3), pp.114-128.
Bhattacharya, D., Dwivedi, V.P., Kumar, S., Reddy, M.C., Van Kaer, L., Moodley, P. and Das, G. 2014. Simultaneous inhibition of T helper 2 and T regulatory cell differentiation by small molecules enhances Bacillus Calmette-Guerin vaccine efficacy against tuberculosis. Journal of Biological Chemistry, 289(48), pp.33404-33411.
Counoupas, C., Pinto, R., Nagalingam, G., Britton, W.J. and Triccas, J.A. 2018. Protective efficacy of recombinant BCG over-expressing protective, stage-specific antigens of Mycobacterium tuberculosis. Vaccine, 36(19), pp.2619-2629.
Da Costa, A.C., de Oliveira Costa-Junior, A., de Oliveira, F.M., Nogueira, S.V., Rosa, J.D., Resende, D.P., Kipnis, A. and Junqueira-Kipnis, A.P. 2014. A new recombinant BCG vaccine induces specific Th17 and Th1 effector cells with higher protective efficacy against tuberculosis. PLoS One, 9(11).
Da Costa, A.C., Nogueira, S.V., Kipnis, A. and Junqueira-Kipnis, A.P. 2014. Recombinant BCG: innovations on an old vaccine. Scope of BCG strains and strategies to improve long-lasting memory. Frontiers in Immunology, 5, p.152.
Hoft, D.F., Blazevic, A., Selimovic, A., Turan, A., Tennant, J., Abate, G., Fulkerson, J., Zak, D.E., Walker, R., McClain, B. and Sadoff, J. 2016. Safety and immunogenicity of the
recombinant BCG vaccine AERAS-422 in healthy BCG-naïve adults: a randomized, active-controlled, first-in-human phase 1 trial. EBioMedicine, 7, pp.278-286.
Horwitz, M.A. and Jia, Q. 2018. Live recombinant booster vaccine against tuberculosis. U.S. Patent 10,010,595.
Oliveira, T.L., Rizzi, C. and Dellagostin, O.A. 2017. Recombinant BCG vaccines: molecular features and their influence in the expression of foreign genes. Applied Microbiology and Biotechnology, 101(18), pp.6865-6877.
Triccas, J.A. and Counoupas, C. 2016. Novel vaccination approaches to prevent tuberculosis in children. Pneumonia, 8(1), p.18.
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