First Vaccine Against Fatal Visceral Leishmaniasis Enters Phase I Trial

As the disease expands its global reach, the Infectious Disease Research Institute teams up with India and the Gates Foundation to target the most deadly form of leishmaniasis.

AsianScientist (Feb. 27, 2012) – The first clinical trial of a new vaccine for visceral leishmaniasis (VL) has been launched by Seattle-based non-profit organization, the Infectious Disease Research Institute (IDRI).

The Phase I trial is taking place in Washington State, with a companion Phase I trial planned in India, where IDRI is transferring its vaccine technology to the Gennova Biopharmaceuticals. Last month, Gennova opened a vaccine formulation center that will be producing vaccines for neglected diseases in Pune, India, where the company is based.

Also known as LEISH–F3 + GLA-SE, the IDRI vaccine is a highly purified, recombinant vaccine. It incorporates two fused Leishmania parasite proteins and a powerful adjuvant to stimulate an immune response against the parasite.

Beginning later in 2012, the Indian biotherapeutics and vaccine manufacturer will produce the LEISH-F3 + GLA-SE vaccine. It will be then tested in healthy Indian adults, in collaboration with the Banaras Hindu University in Varanasi, India.

Both trials are being funded by the Bill & Melinda Gates Foundation, which also recently announced a global partnership with the World Health Organization and 13 pharmaceutical companies to control or eliminate 10 neglected tropical diseases, including leishmaniasis.

Leishmaniasis takes several forms, all of which are caused by the Leishmania parasite and transmitted by infected sand flies. It affects vital organs and bone marrow, destroying white and red blood cells. Because VL attacks the immune system, it has been called the parasitic version of HIV/AIDS.

“Visceral leishmaniasis is a persistent and deadly global health problem,” said Steve Reed, IDRI founder and Chief Scientific Officer, who led the preclinical vaccine work over more than two decades. “Our partnership with India will speed the development of an effective vaccine and accelerate its control.”

VL is most common in India, Nepal, Bangladesh, Sudan, and Brazil and causes about 500,000 cases and 50,000 deaths each year. Cutaneous leishmaniasis, the most common form of the disease, causes serious skin lesions and often leaves its victims permanently disfigured. Leishmaniasis occurs in 88 countries, affecting 12 million people.

While the disease can be treated, current treatments are too expensive, difficult to administer, or toxic for widespread use in poor countries. Drug resistance is also a growing problem, particularly in India. Left untreated, VL has a 90 percent case fatality, and death can come within two years – much more quickly than AIDS.

In India, VL is known as kala-azar, a Hindi word that means black fever, named after the fever that ravages affected individuals, whose skin becomes dark gray.

“Kala-azar is a significant health problem across northern India and neighboring countries,” said Dr. Sanjay Singh, CEO of Gennova.

“Bringing a vaccine to India will not only end deaths and disease, it will also help many of our poorest citizens to lead more productive lives and move out of poverty.”

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Source: IDRI; Photo: Jill Ashman.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

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