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Living Modified Organism
(LMO)
The image below identifies the LMO through its unique identifier, trade name and a link to this page of the BCH. Click on it to download a larger image on your computer. For help on how to use it go to the LMO quick-links page.
Biotech Vac COX
EN
TUBSUB1
No
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Organization:Vetanco do Brasil Importação e Exportação Ltda (Vetanco)R. Edgar Marchiori, 255 - Distrito Industrial Benedito Storani, Vinhedo - SP, 13280-000Vinhedo - SP,
,Phone: [49] 9 9119.1020,Fax:Email: contato@vetanco.com.br,Website: https://www.vetanco.com/br/,
Biotech Vac COX is an oral recombinant veterinary vaccine intended to induce protective immunity against avian coccidiosis caused by different species of Eimeria (coccidia parasite). To achieve protection against Eimeria infections, B. subtilis expresses the TUBSUB1 protein which acts as the vaccine antigen. The antigen induces an immune response that contributes to protection against coccidiosis in birds and pigs. The final vaccine contains no viable modified bacteria, as the recombinant B. subtilis is inactivated before formulation.
The term “Recipient organism” refers to an organism (either already modified or non-modified) that was subjected to genetic modification, whereas “Parental organisms” refers to those that were involved in cross breeding or cell fusion.
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BCH-ORGA-SCBD-103064-6 Organism Bacillus subtilis (Bacillus, BACIU)Bacteria
EN
pHT01
EN
- Agrobacterium-mediated DNA transfer
Some of these genetic elements may be present as fragments or truncated forms. Please see notes below, where applicable.
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BCH-GENE-SCBD-300064-1 Synthetic subtilisinProtein coding sequence | Production of medical or pharmaceutical compounds (human or animal) (Vaccines),Use in industrial applications
Information on the inserted DNA sequence
The modified Bacillus subtilis contains a recombinant pHT01 plasmid carrying a genetic expression cassette for the expression of the TUBSUB1 antigen from Eimeria sp. used in the vaccine formulation. A conserved Eimeria antigen was identified by comparison with a homologous Toxoplasma gondii protein. The corresponding coding sequence was designed in silico, codon-optimized for expression in Bacillus subtilis while maintaining the amino acid sequence of the encoded antigen, chemically synthesized, and cloned into the pHT01 expression plasmid. The coding sequence was inserted into the BamHI/XbaI multiple cloning site of the expression plasmid.
Expression of the TUBSUB1 coding sequence is regulated by a LacI/PgroESL regulatory cassette, in which the groESL operon is composed of the groEL chaperonin and groES helper protein from Bacillus subtilis and transcription is controlled by the LacI repressor encoded by the lacI gene and induced by isopropyl β-D-1-thiogalactopyranoside (IPTG). The expressed TUBSUB1 protein is transported to the bacterial cell surface, where it serves as the immunogenic component of the vaccine. Production of the TUBSUB1 protein is inactivated by treatment with formalin.
The modified Bacillus subtilis contains a recombinant pHT01 plasmid carrying a genetic expression cassette for the expression of the TUBSUB1 antigen from Eimeria sp. used in the vaccine formulation. A conserved Eimeria antigen was identified by comparison with a homologous Toxoplasma gondii protein. The corresponding coding sequence was designed in silico, codon-optimized for expression in Bacillus subtilis while maintaining the amino acid sequence of the encoded antigen, chemically synthesized, and cloned into the pHT01 expression plasmid. The coding sequence was inserted into the BamHI/XbaI multiple cloning site of the expression plasmid.
Expression of the TUBSUB1 coding sequence is regulated by a LacI/PgroESL regulatory cassette, in which the groESL operon is composed of the groEL chaperonin and groES helper protein from Bacillus subtilis and transcription is controlled by the LacI repressor encoded by the lacI gene and induced by isopropyl β-D-1-thiogalactopyranoside (IPTG). The expressed TUBSUB1 protein is transported to the bacterial cell surface, where it serves as the immunogenic component of the vaccine. Production of the TUBSUB1 protein is inactivated by treatment with formalin.
Note
- The recombinant expression plasmid was propagated in Escherichia coli DH5α before transformation into Bacillus subtilis.
- Recombinant transformants were selected on chloramphenicol-containing medium.
- The recombinant plasmid is maintained as an episomal element and is not integrated into the chromosome of Bacillus subtilis.
- The recombinant Bacillus subtilis strain is inactivated prior to incorporation into the final vaccine product, thus the final product vaccine does not contain viable genetically modified bacteria.
EN
- Vaccine
EN
- Biotech Vac COX is an inactivated oral subunit vaccine (TUBSUB1) containing a modified derivative produced by Bacillus subtilis. The LM is inactivated prior to incorporation into the final vaccine formulation and is not intended to replicate following administration.
- The transformation event listed is the transformation event provided by the submitter. Should there be another transformation event available or additional information regarding the modification of Bacillus subtilis for the use of Eimeria spp. vaccine antigen, the record will be updated.
- Poultry Science (2021). Evaluation of a subunit vaccine candidate (Biotech Vac Cox) against Eimeria [PDF] [ English ]
- Patent (2023). Compositions and methods of enhancing immune responses [PDF] ( US11752205 ) [ English ]
- CTNBio Technical Summary: Request for Opinion on Commercial Release of the Biotech Vac COX vaccine [PDF] ( SEI/MCTI, 11775964, Parecer Técnico, Comissão técnica nacional de biossegurança, National Technical Commission on Biosafety ) [ English ]
- BMC Genomics (2012). Stage-specific expression of protease genes in the apicomplexan parasite, Eimeria tenella [PDF] [ English ]
- Life (2023). What Do We Know about Surface Proteins of Chicken Parasites Eimeria [PDF] [ English ]
- Immunology (2010). A protease-dependent mechanism for initiating T-dependent B cell responses to large particulate antigens [PDF] [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | LMO identification | 1 | |
| Risk Assessment generated by a regulatory process | Living modified organism(s) | 1 | |
