The Infectious Disease Research Institute (IDRI) has launched the first human trial of a new vaccine for Visceral Leishmaniasis (VL). The trial is being conducted in Washington State, and a Phase 1 trial is planned in India, where VL is prevalent.
The IDRI is a Seattle-based nonprofit that develops products to prevent, detect, and treat diseases of poverty.
Visceral leishmaniasis is a severe form of leishmaniasis – a disease caused by protozoan parasites and transmitted by the bite of certain species of sand fly. In VL, parasites migrate to the vital organs and bone marrow, destroying white and red blood cells. VL has been called the parasitic version of HIV/AIDs, as it attacks the immune system.
Steve Reed, IDRI founder and Chief Scientific Officer, who led the over twenty years of preclinical vaccine work, explained:
“Visceral leishmaniasis is a persistent and deadly global health problem. Our partnership with India will speed the development of an effective vaccine and accelerate control of the disease.”
VL is most prevalent in Indian, Bangladesh, Nepal, Brazil, and Sudan. In addition, VL causes approximate 500,000 cases and kills 50,000 people each year. The most common form of the disease is Cutaneous leishmaniasis, which causes skin lesions and often leaves the infected individual permanently disfigured. 12 million people from 88 countries are affected by leishmaniasis.
Even though the disease is treatable, current treatments are difficult to administer, too expensive, or toxic for extensive use in developing nations. Furthermore, resistance to treatment is an increasing problem, particularly in India. 90% of people with VL die if the infection is left untreated, and death can come within 2 years, significantly faster than AIDS.
According to researchers the geographical range for leishmaniasis is expanding as a result of mass migration, rapid urbanization, and global warming, with cases being reported in areas that had previously been unaffected.
Therefore, researchers believe that a vaccine is vital to control and eliminate the disease.
Franco Piazza, Medical Director at IDRI and leader of the vaccine’s clinical development, said:
“With this clinical trial, we hope to launch a new era in the fight against Visceral Leishmaniasis. 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 involves 2 fused Leishmaniaparasite proteins and a strong adjuvant to activate an immune response against the parasite.
36 adult volunteers will participate in the Washington State Phase 1 clinical trial. The participants will be randomly assigned to 1 of 3 versions of the vaccine. Each of the 3 vaccines will vary in the amount of adjuvant included. The researchers will assess each version of the vaccines’ safety and immunogenicity.
The IDRI is transferring its vaccine technology to Gennova Biopharmaceuticals, and a second Phase 1 trial will be conducted in India. Gennova recently opened a vaccine formulation center that will generate vaccines for neglected diseases in Pune, India, where the company is located.
In India, VL is known as kala-azar, a Hindi word meaning black fever, named after the fever that ravages affected individuals, whose skin becomes dark gray.
Dr. Sanjay Singh, CEO of Gennova, said:
“Kala-azar is a significant health problem across northern India and neighboring countries. 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.”
The Indian vaccine manufacturer will produce the LEISH-F3 + GLA-SE vaccine later in 2012. The vaccine will then be tested on healthy adults in Indian, in collaboration with the Banaras Hindu University in Varanasi, India.
Dr. Shyam Sundar, Professor of Medicine at the University’s Institute of Medical Sciences, said:
“We are very pleased to be working with IDRI on this vaccine, which is critically important to the many people who suffer from this disease in India as well as to the millions of people who are infected around the world.”
The researchers will conduct subsequent human trials that will involve more participants who are at high risk VL, as they are frequently bitten by sand flies. Larger trials, carried out in real-life settings of disease exposure, are the only way to determine the full effectiveness of the vaccine.
Dr. N. K. Ganguly, a highly distinguished biotechnology professor and advisor in India, and former Director General of the Indian Council of Medical Research (ICMR), New Delhi, said:
“Vaccines can do what medicines can’t – prevent the disease from even occurring. Only with an effective vaccine can we expect to control leishmaniasis in South Asia.”
The Bill & Melinda Gates Foundation is funding the Phase 1 clinical trials. The foundation has recently announced a worldwide partnership with the WHO and 13 pharmaceutical companies to control or eliminate 10 neglected tropical diseases, including leishmaniasis.
Written by Grace Rattue