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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of the InnovaxND Vaccine - Technical Opinion No. 3265/2012.
EN
15 Mar 2012
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Intervet do Brasil Veterinária Ltda (INTERVET)Private sector (business and industry)Av. Sir Henry Wellcome 335, Prédio Administrativo, 1º andar, Ala "E", Moinho Velho.Cotia, São Paulo
06714-050, BrazilPhone: 55 (11) 4613-4000 / 4613-4006,Fax: 55 (11) 4613-4000 / 4613-4006,Email: sonia.bognar@intervet.com,Website:
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INNOVAX® ND Vaccine| Intervet do Brasil Veterinária Ltda(INTERVET) | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
- Commercial release 3265-2012.pdf [ Portuguese ]
For the production of the recombinant vaccine, the non-virulent, non-pathogenic strain of Marek's disease virus HVT PB1 was used, which has been used as a vaccine for over two decades. As a vaccine, it has as an important characteristic the great biological containment, due to its non-spreading nature and not infecting other species besides birds. The vector used to clone the F gene of NDV was pVEC04. This vector was generated by Sondermeijer et al. (1993). The gene encoding the F protein was isolated from viral RNA with the synthesis of a cDNA, prepared from NDVs grown in embryonated eggs. The gene was inserted into the BglII site of the recombinant HVT vector at the BamHI site (as a result, the BglII site was lost), resulting in plasmid pNDV04. The modified virus was obtained by homologous recombination and plaque purification was performed to obtain the recombinant HVT virus: HVT/NDV-F. The only difference between the recombinant HVT/NDV-F strain and the original HVT strain is the insertion of the NDV fragment containing the F gene and the respective promoter region. The recombinant virus does not have sequences from the plasmid used in the recombination experiment (pVEC04) or marker genes. This generated a recombinant organism (HVT/NDV-F) that can be used as a vaccine against both Marek's disease and Newcastle disease.
There is no evidence that the use of this vaccine strain poses risks to human health, vaccinated animals or the environment. environment.
Studies on the effect of the vaccine strain on non-target species, on the distribution of the virus in the target species, and on the spread and replication of the virus have shown that the HVT/NDV-F strain does not behave differently than the HVT PB1 strain. . To assess genetic stability, two studies were conducted. In both, after five passages in chickens, no specific lesions for Marek's Disease were observed. Immunofluorescence studies showed that after 5 passages in chickens, F protein expression remained stable. Likewise, DNA hybridization through Southern blot demonstrated the non-occurrence of gene reorganization, so it can be concluded that the F gene is stable in the genome of the HVT/NDV-F virus and that there was no loss or rearrangement of genes. Other tests were done in vitro, and no evidence of genetic alteration was observed.
This new vaccine is similar to other vaccines with the same purpose already approved and considered safe by the CTNBio.
The risk classification of the genetically modified organism present in the vaccine is risk class 1 (low individual risk and low risk for the community); 2- The stability of HVT/NDV-F was demonstrated by several passages in cells, with Southern analyses, in which genomic reorganizations were not observed; 3- Studies to verify the spread of HVT/NDV-F in comparison with the parental HVT in chickens, pigeons, ducks and turkeys, showed that there are no differences for this factor; 4- The recombinant virus is not resistant to desiccation and is not spread horizontally from chicken to chicken; 5- This new vaccine is similar to other vaccines with the same purpose already approved and considered safe by CTNBio; 6- That genetic modification does not generate significant changes, from a biosafety point of view, in relation to the parental virus, with a safe history of use as a vaccine for 25 years; 7- There is no evidence that the use of this vaccine strain poses risks to human health, vaccinated animals or the environment.
Several studies were carried out with the aim of observing whether the behavior of the recombinant virus differed from the parental vaccine strain. All parameters evaluated showed that the biological characteristics of HVT/NDV-F are not different from the biological characteristics of the parental virus, in terms of in vivo replication and tissue tropism.
The vaccine poses no risk to human health, vaccinated animals or the environment.
It fully complies with CTNBio's rules and relevant legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
Molecular traditional methods.
Yes
No
No
EN
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