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Development of new leishmaniosis vaccine

The scope of this project is to complete the r&d required for obtaining the market authorization of a new recombinant vaccine against canine leishmaniasis, which has been shown protective in experimental trials in dogs with better performance than that of gold-standards.

Leishmaniasis is one of the most worrisome zoonotic diseases. It is caused by intracellular protozoan parasites of the Leishmania genera, which are transmitted by the bite of infected phlebotomines (sand fly). The infection is chronic and there three main forms of the disease: (1) visceral leishmaniasis, which is the gravest form, (2) cutaneous and (3) mucocutaneous leishmaniasis. Although there are more than 70 species that might act as reservoirs for the parasite, dogs are the most relevant epidemiologically. The disease is global and its incidence is rapidly growing. There are between 900.000 and 1.3 million new cases each year, while the yearly death rate ranges from 20.000 to 30.000 based on data of the World Health Organization (WHO 2016). In the countries of origin of the participants in this project, Argentina and Spain, the disease is endemic. In the Latin American countries where the disease is endemic, 43.57% of the population is at risk of suffering leishmaniasis (WHO 2016). Among Leishmania species, Leishmania infantum is the major causal agent of human visceral leishmaniasis and of horizontal transmission between humans and dogs in both Argentina and Spain. Exposure to the vector is increasing due to environmental changes linked to expansion of the geographical area occupied by phlebotomines. Development of the disease in humans needs some degree of immunodepression, usually linked to malnutrition, migration or poor housing conditions. Therefore it is an unmet disease targeting the poor. All cases of canine leishmaniosis in Europe are caused by L. infantum, where no other Leishmania species have been diagnosed. Millions of dogs are infected in South America, with high infection rates in some areas of Brazil and Venezuela. Seroprevalence studies from Italy, Spain, France and Portugal report that 3 million dogs in these countries are infected. The seroprevalence in dogs in the Mediterranean basin ranges from 5% to 30% depending on regions. Canine L. infantum infection leads to several degrees of disease severity are found in dogs, ranging from mild to severe fatal disease. The "resistant" dogs, which are able to maintain a chronic subclinical infection are able to raise a protective T-cell-mediated immune response featuring production of Th1 cytokines such as INF-gamma, IL-2 and TNF-alfa, which induce anti-Leishmania activity by apoptosis of parasites in macrophages via nitric oxide metabolism, while the sick dogs are characterized by a marked humoral immune response, reduced cell-mediated immunity, a mixed Th1- Th2 cytokine pattern and high parasite burden, which is detrimental to the animal. There are two vaccines registered in Europe against canine leishmaniasis and a third vaccine registered in Brazil. However, the performance of the vaccines is suboptimal, and there is still the need of development of a more protective vaccine with better properties, which will allow more comprehensive vaccination programs in dogs in order to reduce significantly the incidence of the disease. Once the vaccine in animal health was achieved, in a second stage, it could be valued for its usefulness in human medicine. This project begins with a recombinant vaccine named BNT005, which has been already developed until the stage of experimental trials of protection in Beagle dogs performed with laboratory batches in Spain. We apply for funds in order to (1) advance in development of the industrial manufacturing process, (2) perform experimental trials of protection of dogs in Argentina, in order to show global application of BNT005, and (3) perform experimental trials in Beagle dogs to show that the vaccine is not only protective but curative, which will add a significant milestone to the product and its reachable market. The activities for reaching the general objectives 1 and 2 will be carried out by Biotandil, after the technology transfer of the product from Bionaturis. Bionaturis will carry out the activities of milestone 3. Importantly, a competitive advantage of BNT005 over other vaccines, shown in the experiments carried out so far, is its ability to raise a significant specific cell-mediated immunity in the dogs, which correlates with protection. Products able to raise cell-mediated immunity could prevent many parasitic diseases and not only Leishmaniasis. Bionaturis and Biotandil have signed an agreement for taking BNT005 until reaching market authorization in Argentina. Biotandil has shown already its capacity for development, manufacturing, and marketing of Tricovac®, a vaccine against a sexually transmitted parasite.
Acronym: 
BNT005
Project ID: 
11 694
Start date: 
01-09-2017
Project Duration: 
36months
Project costs: 
800 000.00€
Technological Area: 
Biology / Biotechnology
Market Area: 
MEDICAL / HEALTH RELATED

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