World's first kala azar vaccine enters the clinic

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Leishmaniasis comes in a number of forms, but visceral leishmaniasis is the worst. Left untreated, it is almost always fatal within two years. However, a Seattle-based nonprofit has started a human trial of a vaccine that could start to make the disease a thing of the past.

Visceral leishmaniasis, also known as kala azar, is caused by the Leishmania parasite. The parasite causes fever and weight loss, attacks the spleen and the liver, and destroys red and white blood cells, leading to anemia. It causes around 50,000 deaths each year. Visceral leishmaniasis is most common in India, Nepal, Bangladesh, Sudan and Brazil, and its range is spreading.

The nonprofit Infectious Disease Research Institute (IDRI) has launched what it believes to be the world's first clinical trial of a vaccine against the parasite. The vaccine, code-named LEISH–F3 + GLA-SE, includes a recombinant form of two fused Leishmania parasite proteins with an adjuvant to promote the immune response. The first trial, which is taking place in Washington, will include 36 volunteers who will receive the vaccine with three different doses of the adjuvant. This will be followed up with a Phase I trial in healthy volunteers in India with IDRI's partner Gennova Biopharmaceuticals, in collaboration with the Banaras Hindu University. The Phase I trials are funded by the Bill & Melinda Gates Foundation.

"Visceral leishmaniasis is a persistent and deadly global health problem," said Steve Reed, IDRI founder and chief scientific officer, who led the more than 20 years of preclinical vaccine work. "Our partnership with India will speed the development of an effective vaccine and accelerate its control."

Because current treatments for visceral leishmaniasis are expensive, difficult to administer or toxic, a vaccine that is low-cost and easy to administer could be a step in controlling this deadly disease. However, many more trials will be needed before this vaccine reaches the market.

- read the press release