The first-of-its-kind clinical trial to test the efficacy of a novel visceral leishmaniasis vaccine has started in India as part of a joint initiative by the Infectious Diseases Research Institute (IDRI), a Seattle-based non-profit organization in the US, and Pune-based Gennova Biopharmaceuticals in India. The announcement came close on the heels of Indian Immunologicals conducting pre-clinical studies for the world's first chikungunya vaccine. There are no vaccines for either of the two diseases till now.

Traditionally, falling under the ambit of ‘neglected tropical diseases', cases of visceral leishmaniasis and chikungunya are found largely in developing countries only. Due to low or no prevalence in developed countries, the market size for vaccines or drugs for these diseases are not considered to be highly profitable. In light of this, the fact that Indian companies are now taking the initiative to develop solutions for such problems is a welcome move.

According to the World Health Organisation (WHO), Leishmaniasis is found in 88 countries, with 1.6 million cases estimated to occur worldwide. The most pathogenic form of this disease is Visceral Leishmaniasis, more commonly known as kala azar or black fever, a name derived from the darkening of face, hand, feet and abdomen skin, which is a common occurrence in this disease. Since mandatory reporting is present in only 33 of the affected countries, only six lakh cases of leishmaniasis are reported, of which five lakh are that of visceral leishmaniasis. Over 90 percent of these cases occur in Bangladesh, Brazil, Ethiopia, India, Nepal and Sudan, causing 50,000 deaths every year, which makes it the second-largest parasitic killer in the world. If left untreated, kala azar has 90 percent chances of case fatality with death with two years.

Kala azar is caused due to a parasite of the genus Leishmania. The pathogenesis is very much like that of the malarial parasite where the pathogen spreads through the insect vector, a sandfly. The current treatment modalities involving amphotericin still remain expensive in developing countries such as India where, Bihar, with a large population below the poverty line, is the worst affected state. Of late, kala azar has been in the news for patients showing co-infection with Leishmania and HIV, an emerging problem that could escalate further.

Dr Sanjay Singh, chief executive officer, Gennova Biopharmaceuticals, outlines the plan for kala azar vaccine. "The kala azar vaccine is a joint effort between the IDRI, which developed the vaccine, Gennova, which will produce the vaccine, and Banaras Hindu University Medical Institute that will conduct the phase I trials. The phase I trial, which have to be first conducted in the US for the highly purified, recombinant vaccine, have already started after which the Indian trials will be initiated," he informs.

He adds that if successful "we hope to conduct the phase II trials soon, with support from the Department of Biotechnology". "Being a parasitic disease, developing a vaccine for kala azar has been very tough, but our motivation for eradicating it is very strong. The vaccine would be produced at the recently inaugurated Vaccine Formulation and Research Center inaugurated recently at Gennova," he says.