The Neoleish vaccine, with the participation of the Margarita Salas Biological Research Centre (CIB-CSIC), prevents infection and reduces the presence of the parasite by more than 90%.

Intracellular phase of the parasite Leishmania spp. in bone marrow cells of a dog. / CIB-CSIC

A team formed by the Zendal group and scientists from the CSIC developed in 2022 the first vaccine for mammalian animals based on recombinant DNA to tackle canine leishmaniasis, a parasite that causes everything from skin ulcers to severe inflammation of the liver and spleen.

A few days ago, the company specialising in pets Petia, part of the pharmaceutical group Zendal, presented its arrival on the market at the XLI Annual Congress of the Madrid Association of Pet Veterinarians held at IFEMA. The vaccine is capable of reducing the risk of infection after exposure to the parasite and reduces its presence in nine out of ten cases.

Leishmaniasis is a disease caused by the Leishmania parasite, of the trypanosomatid family, which is carried by the phlebotomine sandfly. It is a severe zoonosis (meaning that it is transmitted from animals to humans), present in the Mediterranean basin, Asia and America, which can cause death without treatment and whose main reservoir is the dog. The clinical manifestations of the disease range from spontaneously healing skin ulcers to fatal forms in which severe inflammation of the liver and spleen occurs. Between 500,000 and one million new cases occur each year and, in Spain, it is estimated that almost 30% of dogs have had contact with the parasite.

‘It is a peculiar parasitic protozoan that is introduced into the cells of the immune system of the animal it infects and thus protects itself from the antibodies it generates to eliminate it. It therefore requires, for its protection, the activation of the so-called cellular pathway (the well-known killer cells and T lymphocytes) in order to be eliminated,’ says CSIC researcher Vicente Larraga, from the Molecular Parasitology group at the Margarita Salas Biological Research Centre (CIB-CSIC), who has led the development together with CIB-CSIC researchers Pedro José Alcolea and Ana Alonso Ayala.

It is a highly innovative vaccine that uses DNA technology, based on fragments of genetic information that encode immunogens, making it the third vaccine of its kind to be marketed in the world

Neoleish is a highly innovative vaccine that uses DNA technology, based on fragments of genetic information that encode immunogens, making it the third vaccine of its kind to be marketed in the world. Named by the European Medicines Agency (EMA) as one of the three innovative biotech medicines of the year 2022, it received marketing authorisation as a veterinary medicinal product for dogs in November 2022.

The vaccine specifically activates the cellular defence pathway in infected animals and reduces, by more than 90%, the presence of the parasite within the cells of vaccinated dogs. In addition, it allows active immunisation of Leishmania-negative dogs from 6 months of age to reduce the risk of developing active infection and/or clinical disease following exposure to Leishmania infantum.

‘This is an important milestone for the company, given the importance of this vaccine in the pet health environment,’ said Troncoso. ‘Once again, the combination of public-private synergies has produced good results in the biopharmaceutical field. The Zendal-CSIC alliance has achieved a milestone in animal vaccinology. After a long time of research, today we are putting a safe vaccine on the market, belonging to the most innovative group, the so-called third generation vaccines,’ concludes Andrés Fernández, CEO of Zendal.

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