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Modified Organism
Bovela® Vaccine
Record information and status
Record ID
Date of creation
2016-06-23 18:14 UTC (gutemberg.sousa@mctic.gov.br)
Date of last update
2016-08-03 16:55 UTC (dina.abdelhakim@cbd.int)
Date of publication
2016-08-03 16:55 UTC (dina.abdelhakim@cbd.int)

Living Modified Organism identity
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.

LMO name
Bovela® Vaccine
Transformation event
Dra Patrícia Schwarz
technician in charge representing
Boheringer Ingelheim Química e Farmacêutica Ltda.
Avenida das Nações Unidas, 14171, 18º andar - Torre B - Vila Gertrudes. 04794-000.
São Paulo, São Paulo
Brazil, 04794-000
Phone:55 11 4949-4700
Fax:55 11 4949-4700
Url:Boheringer Ingelheim
Bovela is a vaccine  developed to immunize bovines against the disease caused by the bovine viral diarrhea virus (BVDV) types 1 and 2, including the vaccination of cows and calves, in order to protect the fetus against transplacental BVDV infection.

This virus is a single stranded positive-sense RNA pestivirus from the Flaviviridae family that replicates only in the cytoplasm. Its genetic material codes for the EMS and NPRO proteins, which in their native form inhibit the interferon dependent (IFN-gamma) immune response type Th1, therefore inhibiting the host immune response.

The absence of coding sequences for these viral genome proteins impairs the virus's ability to inhibit the production of interferon, therefore promoting the host immune system. The vaccine is adjuvant-free and targeted for the active immunization  of pregnant cows and of animals after three months of age, in order to reduce the clinical symptoms of the disease, viremia and viral excretion.
Recipient Organism or Parental Organisms
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.
Pestivirus A - BVDV-1
Pestivirus B - BVDV-2
Point of collection or acquisition of the recipient organism
Parental strains of the two viral types were isolated from animals infected in Germany (KE9, BVDV-1) and the United States (NY-93 and BVDV-2).
Characteristics of the transformation process
pXIKE-B-NdN and pKANE99C
Techniques used for the modification
  • Virus-mediated gene transfer
Introduced or modified genetic elements
Some of these genetic elements may be present as fragments or truncated forms. Please see notes below, where applicable.
Erns coding sequence - Pestivirus A - BVDV-1
Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Npro coding sequence - Pestivirus A - BVDV-1
Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Notes regarding the genetic elements introduced or modified in this LMO
Briefly, modified BVDV-1 and BVDV-2 RNA were transcribed in vitro from complete clones of cDNA pXYKE-B-NdN (corresponding to the modified BVDV-2) and pKANE99C (corresponding to the modified BVDV-1). Later on, the BVDV strains were propagated in MDBK-B2 cells lineage and the viral RNA was extracted to establish the cDNA standard library and to its extension by polymerase (RT-PCR) chain reaction. The target living virus, modified and attenuated, were obtained by cDNA elaboration after in vitro transcription and RNA transfection of MDBK cells.

Sequencing of master virus seeds (MVS) to modified BVDVs were used to inoculation in MDBKB2 cells and, after 48 hours of incubation, the supernatant material was removed and cells were cleansed and lysed. Total RNA was extracted from cells, examined for integrity and later converted into cDNA for sequencing. Results of sequencing the established MVS confirmed the presence of introduced deletions in Npro and Erns. When compared, the MVS sequences and original isolated KE9 and NY93 showed the presence of just minor differences in nucleotides that were determined to have no influence over the attenuated phenotype.

PCR data obtained for MVS and WVS (MVS + 5) of strains in vaccines of modified BVDV have also confirmed the presence of the introduced Npro deletion. The in vitro data were also supported by PCR data obtained in BVDV (virus isolation method) positive samples which showed that the introduced Npro deletion remained stable for several in vitro passages. Jointly, the data show that BVDV genomes containing the inserted deletions are genetically stable in vitro and in vivo.
LMO characteristics
Modified traits
Common use(s)
  • Vaccine

Records referencing this document (2)
2record(s) found
Country's Decision or any other Communication1 record
Risk Assessment1 record