The trial for the first ever vaccine to prevent kala azar, or visceral leishmaniasis (VL), is all set to begin in the US and India.
The trials funded by the Bill & Melinda Gates Foundation are launched by the Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research body with a companion Phase 1 trial planned in India, an epicenter of the disease.
IDRI is transferring its technology to Pune's Gennova Biopharmaceuticals, which has opened a new facility that will produce the candidate vaccine for the clinical trial to begin later in 2012.
The phase-1 trial in the US has been launched in Washington state in the US, IDRI said.
"Our partnership with India will speed the development of an effective vaccine and accelerate control of the disease," IDRI founder and Chief Scientific Officer Steve Reed told IANS at the opening of the new facility in Pune last month.
"The trials (in the US and India) are a milestone toward halting a disease with a 90 percent fatality rate within two years if left untreated, killing much more quickly than AIDS," IDRI said in a statement.
VL affects vital organs and bone marrow, destroying white and red blood cells. If untreated it can kill within two years.
It causes about 500,000 cases and 50,000 deaths each year, and is most common in India, Nepal, Bangladesh, Sudan and Brazil.
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.
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, IDRI said.
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 to evaluate the safety and immunogenicity of the vaccine will enrol 36 adult volunteers in Washington.
The second Phase 1 trial will take place in India where the vaccine produced at Gennova's new facility in Pune will be tested on healthy adults, in collaboration with the Banaras Hindu University in Varanasi.
"Kala azar is a significant health problem across northern India and neighbouring countries," said 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."
The IDRI said that subsequent clinical trials will involve larger numbers of people who are at high risk of developing VL during their daily lives, because they are frequently bitten by sand flies.
Only such large trials, conducted in real-life situations of disease exposure, will determine the full effectiveness of the vaccine.
(K.S. Jayaraman can be contacted at [email protected]