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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of the INNOVAX ILT Vaccine - Technical Opinion No. 2872/2011.
EN
31 Aug 2010
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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,Phone: (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,Phone: 55 (11) 4613-4000 / 4613-4006,Fax: 55 (11) 4613-4000 / 4613-4006,Email: sonia.bognar@intervet.com,Website:
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INNOVAX®-ILT| MSD Animal Health | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
- Commercial release 2872-2011.pdf [ Portuguese ]
The ILTV gD and gI genes, containing the regulatory regions, were inserted into the HVT FC-126 sample by homologous recombination by overlapping fragments, resulting in the sample named HVT/ILT-138. For this construction, the gD and gI genes were inserted into the 711-92.1A vector, in the PacI site previously inserted by cloning a synthetic DNA sequence in the XhoI site of the vector. This vector, with the ILTV genes inserted, was used in a cotransfection with the HVT FC126 sample to generate HVT/ILT-138: in this process, there was a homologous recombination between the vector and the recipient sample. The only difference between the recombinant HVT/ILT-138 sample and the parental HVT FC126 sample is the insertion of the ILTV fragment containing the gD and gI genes. Plasmid sequences or markers are not present in the recombinant virus.
The vaccine is safe for use in chickens and poses no safety risk.
The vaccine has been shown to be safe for use in chickens. Chickens were vaccinated by puncturing the wing membrane with a 10X dose of the vaccine. After an observation period of 21 days, no adverse reactions or clinical signs of BA, MG, EA were observed. Thus, the vaccine is safe for use in chickens and poses no safety risk. Vaccine safety was also evaluated during the efficacy study. Chickens were vaccinated at 8 weeks of age. Birds were kept for three weeks to develop immunity before challenge. During this period, birds were observed daily and no adverse reactions or clinical signs of FP, MG or AE were observed. After the observation period, the birds were challenged and the vaccine was effective against challenge with FP, MG or EA. When chickens were vaccinated via wing membrane puncture with a 100X dose of vaccine, after an observation period of 21 days, no adverse reactions or clinical signs of BA, MG or AE were observed. There were also no reported adverse reactions associated with the parental FPV sample, such as the USDA-licensed vaccine used in the US, which was used to build the vaccine.
There is no evidence that the use of this vaccine strain poses any risks to human health, vaccinated animals or the environment.
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); whereas the data presented show that this vaccine does not entail additional risks to the environment and animal production;. that there is a history of safe use of a similar recombinant vaccine (Vectormune HVT-IBD), using the same virus, but with the viral protein VP2 of the Gumboro Disease virus strain, has already been analyzed by CTNBio and considered safe for commercial use, favorable to the release of this vaccine for commercialization for application in birds; there is no evidence that the use of this vaccine strain poses risks to human health, vaccinated animals or the environment.
Safety was demonstrated in other avian species (turkeys, quails, finches, and doves) by: (1) vaccination with the vaccine or the parental FPV sample and (2) comparison of clinical signs, adverse reactions, and viral isolation between the two groups. vaccinated. The results showed that other avian species vaccinated with the vaccine showed no clinical signs or adverse reactions and no virus was isolated from the inoculation site or from the blood or trachea of quails, birds and doves. Identical results were also obtained when avian species were inoculated with the parental FPV sample. According to literature data, FPV is known to replicate in turkeys and is used for thigh scarification vaccination (Tripathy & Reed, 1997, Winterfield & Reed, 1985 Poultry Science 64, 65-70, Winterfield et al., 1985 Poultry Science 64, 2076-2080.). From the turkeys, the recombinant and the parental FPV were isolated from the inoculation site only up to 7 days after inoculation. Based on these results, it was shown that the host range of the vaccine is similar to the parental FPV sample. Thus, the vaccine is safe for these avian species and use in chickens does not pose any safety risk to other avian species.
No adverse reactions were observed.
The Commission considered that the information provided and the other proposed biosafety measures comply with the CTNBio norms and the pertinent 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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