A team of Spanish researchers is developing a tuberculosis vaccine that is now making history by entering phase 3, which means the last stage of clinical research before it becomes possible. The first vaccine is an attenuated human pathogen to reach this stage. To promote its development and contribute to the eradication of tuberculosis, they present the T.END Foundation, which aims to concentrate efforts and financing that they so badly need to complete their development.

According to data from the World Health Organization (WHO), about a third of the world’s population is infected with the tuberculosis bacillus, but only a small proportion of those infected will end up suffering from it. One of the goals of the Sustainable Development Goals 2030 is to end this global epidemic.

The Spanish team, led by Carlos Martin, a research leader and professor of Microbiology at the University of Zaragoza, is looking for a vaccine capable of eradicating this disease. The first attenuated vaccine is based on a human pathogen that has reached stage 3 (the last before its commercialization). To do this they will try to vaccinate more than 7000 fetuses from South Africa, Madagascar and Senegal.

Preliminary results from clinical trials of this Spanish vaccine suggest that it is safe and well tolerated. To talk about this phase 3 vaccine and the need for its commercialization, OKSALUD interviews Carlos Martín.

QUESTION Why is tuberculosis such a serious disease?

A.- In 2021, it is estimated that 1.6 million people will have died of tuberculosis and more than 10 million people will be infected with this disease, of which more than 500,000 would be resistant to conventional treatment. The death rate of a tuberculosis patient, without treatment, is 50% and it was only surpassed by COVID-19 in 2020, but this year tuberculosis is surpassing CVID-19 again.

Q.- Why is the tuberculosis vaccine not in the Spanish vaccination schedule?

A. – The current BCG vaccine has been used for more than 100 years and protects against the most serious forms of tuberculosis in children, such as meningeal or disseminated, but not against the respiratory forms that are responsible for its transmission. BCG is indicated in regions where tuberculosis numbers are very high. It is not included in the schedule of Europe or the United States of America or Australia and, despite this, BCG continues to be one of the most widely used vaccines in the world, with vaccination coverage of 90% of the world’s population.

Q.- What makes these Spanish vaccines different? Which?

A.- The attenuated BCG vaccine was derived from a strain that caused tuberculosis in cows (Mycobacterium bovis), while MTBVAC was constructed by genetic engineering from a strain that caused tuberculosis in humans (Mycobacterium tuberculosis). Therefore, the antigen content of MTBVAC is higher than BCG and contains antigens absent in BCG. We believe that the antigens absent in BCG and in MTBVAC are present against essential respiratory forms of human tuberculosis. Currently, studies are directed at infants born in countries with a high incidence of tuberculosis. In the future, its effectiveness will be investigated in adolescents and adults.

Q.- The first attenuated vaccine based on a human pathogen that reaches Phase 3 in Spain: what does this imply?

A. – After more than 20 years of MTBVAC construction and research from a Spanish university approaching its industrial and clinical development by the Spanish biopharmaceutical company Biofabri (belonging to the Zendal group), the vaccine has passed different preclinical stages. development In 2012, its safety and immunogenicity clinical studies began in humans: Phase 1a in adults, Phase 1b in fetuses, and Phase 2 safety and immunogenicity in several fetuses. Entering Phase 3 efficacy means it’s time to “break through” time, proving how well the current BCG vaccine protects against respiratory forms of the disease.

Q.- How much time did the research take to reach this point?

A. – As I said before, it has been more than 20 years of construction and research of MTBVAC, to which we must add another more than 15 years of development of technology (development of genetic tools) to be able to build MTBVAC. .

Q:- Why don’t you have the necessary financing?

A. Tuberculosis is a disease that now has epidemics in low and middle regions. It is one of the three diseases of poverty, along with AIDS and malaria. Tuberculosis is also a cause of poverty, affecting the population of reproductive age. The vaccine is essential for these countries, but the low purchasing power for the vaccine at a high price makes the development of a vaccine against tuberculosis very unattractive for large pharmaceutical multinationals.

Q.- How long can they be sold?

A.- When the Phase 3 efficacy in children ends, if we demonstrate that it is more effective than the current BCG. For this we need to complete the financing of this Phase 3 study, which the European Union finances through its EDCTP program (for the development of clinical trials in Africa). That is why the T.END Foundation is seeking the cooperation of Institutions, Philanthropists, Major National Brands, etc. that they can altruistically contribute to the realization that in Spain a vaccine was built and developed to end the tuberculosis disease, which caused the most deaths in history and continues today to be the infectious disease that causes the most deaths. planets

Q.- Is it universally accessible?

A. – Our concern has never been financial. From the beginning of the “Spanish vaccine against tuberculosis” project, we have been looking for a vaccine for universal use, ready and affordable for the countries that need it most and MTBVAC can be this vaccine!

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