03 March 2012
By Kounteya Sinha
New Delhi India
Phase I Trial On 36 Adult Volunteers Begins In Washington, Indian Trials In Collaboration With BHU
India and the US have jointly started human trials of a new and powerful vaccine against kalazar. The disease is the second largest parasitic killer in the world after malaria, with a 90% fatality rate within two years if left untreated.
The Phase 1 clinical trial on 36 adult volunteers has started in Washington that will evaluate the vaccine’s safety and immunogenicity. A second trial will be conducted in India for which Seattle–based Infectious Disease Research Institute (IDRI) has transferred its technology to Pune’s Gennova Biopharmaceuticals. Gennova will produce the candidate vaccine.
The LEISH–F3 + GLA–SE vaccine will be tested on healthy Indian adults in collaboration with the Banaras Hindu University later this year. The vaccine is a highly purified, recombinant and incorporates two fused parasite proteins and a powerful adjuvant to stimulate an immune response. “ Vaccines can do what medicines cannot – prevent the disease from even occurring,” said Dr N K Ganguly, former director general of the Indian Council of Medical Research (ICMR). “Only with an effective vaccine can we expect to control kalazar in south Asia,” he said.
Kalazar, which is transmitted through the bite of a sand fly, causes about five lakh cases and 50,000 deaths each year across 88 countries and is most common in India, Nepal, Bangladesh, Sudan and Brazil.
Kalazar affects vital organs and bone marrow, destroying white and red blood cells. Because it attacks the immune system, it has been called the parasitic version of HIV/AIDS. “Visceral leishmaniasis or Kalazar 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,” said Steve Reed, founder of IDRI.
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 a growing problem in India. Scientists warn that the geographical range for leishmaniasis is expanding. Spurred by global warming, mass migration and rapid urbanization, cases are being reported in previously unaffected areas.
“Given such challenges, a vaccine is considered essential to control and eliminate the disease. With this clinical trial, we hope to launch a new era in the fight against Visceral leishmaniasis,” said Franco Piazza, leader of the vaccine’s clinical development.
Subsequent clinical trials will involve more people, who are at high risk of developing kalazar 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 LEISHF3 + GLA–SE vaccine.
India missed the National Health Policy target to eliminate Kalazar by 2010, and has now set a new target to eliminate or reduce the number of cases to one per 10,000 people by 2015.
“We have missed the 2010 target. According to a tripartite treaty among Bangladesh, Nepal and India, the new elimination target date is 2015. Elimination means reducing number of cases to one per 10,000 people,” a Union health ministry official said. He added, “Only 542 blocks across India report the infection. And in 50% of these blocks, we have eliminated the disease.”Killer Sting
Kalazar is endemic in 48 dists in Bihar, Jharkhand, UP, W Bengal About 65.4 million people are at risk in these four states WHO’s deadline to eliminate kalazar from S–E Asia expires in 2016 Of 38 dists in Bihar, 31 are kalazar–prone Also known as black fever, it afflicts poor people The infection causes Visceral leishmaniasis that attacks liver and spleen, causing irregular bouts of fever and substantial weightloss In developing countries, where patients generally have poor nutrition and compromised immune function, it is 100% fatal without treatment Kalazar tends to recur after every 15 years