Vaccine trial for kala azar soon

 The first-ever vaccine to prevent kala azar, the world’s second largest parasitic killer after malaria, has been developed and clinical trials to test it is being planned in India, the epicentre of the disease, along with the US.

Visceral leishmaniasis (VL) or black fever affects 500,000 people each year in India, Nepal, Bangladesh, Sudan, and Brazil and also called the “parasitic version of HIV.”

According to the National Vector-borne Disease Control programme, more than 25,000 cases had been reported in 2010 in India with 73 deaths.

The vaccine, which took researchers more than two decades to develop, entered Phase I trials in recent weeks, according to the Vaccine’s developer Steve Reed, founder of the Infectious Disease Research Institute (IDRI).

The Phase 1 trial is taking place in Washington State, with a companion Phase 1 trial planned in India.

“Vaccines can do what medicines can’t – prevent the disease from even occurring,” said Dr N K Ganguly, a highly distinguished biotechnology professor and former Director General of the Indian Council of Medical Research (ICMR).

“Only with an effective vaccine can we expect to control leishmaniasis in South Asia.”
The Phase 1 clinical trials are being funded by the Bill & Melinda Gates Foundation, which also recently announced a global partnership with the World Health Organisation and 13 pharmaceutical companies to control or eliminate 10 neglected tropical diseases, including leishmaniasis.

VL 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.

Leishmaniasis takes several forms, all of which are caused by the Leishmania parasite and transmitted by infected sand flies. 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. LV has a 90 per cent fatality rate when left untreated and death can come within two years—much more quickly than AIDS.

“With this clinical trial, we hope to launch a new era in the fight against Visceral Leishmaniasis,” saidFranco Piazza, Medical Director at IDRI and leader of the vaccine’s clinical development.

“For the first time, an advanced vaccine to prevent this devastating disease is being tested in people.”

The IDRI vaccine, known as LEISH–F3 + GLA-SE, 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.

The Phase 1 clinical trial will enroll 36 adult volunteers in Washington State.
They will be randomly assigned to receive one of three versions of the vaccine, which differ in the amount of adjuvant included.

The trial will evaluate the safety and immunogenicity of each version.

A second Phase 1 trial will take place 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.

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

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.