Companion trial is planned for India
The Infectious Disease Research Institute (IDRI), based in Seattle, US, has launched the first clinical trial of a new vaccine for visceral leishmaniasis (VL).
The Phase 1 trial, funded by the Bill & Melinda Gates Foundation, is taking place in Washington State, with a companion trial planned in India, an epicentre of the disease. 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 grey.
VL affects vital organs and bone marrow, destroying white and red blood cells and because it attacks the immune system, it has been called the parasitic version of HIV/AIDS.
‘Visceral leishmaniasis is a persistent and deadly global health problem,’ said Steve Reed, IDRI founder and chief scientific officer, who led the preclinical vaccine work for more than 20 years. ‘Our partnership with India will speed the development of an effective vaccine and accelerate its control.’
VL is most common in India, Nepal, Bangladesh, Sudan and Brazil and causes about 500,000 cases and 50,000 deaths each year.
‘With this clinical trial, we hope to launch a new era in the fight against visceral leishmaniasis,’ said Franco Piazza, medical director at IDRI and leader of the vaccine’s clinical development.
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 enrol 36 adult volunteers. 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.
The companion trial will take place in India, where IDRI is transferring its vaccine technology to Gennova Biopharmaceuticals. Last month, Gennova opened a vaccine formulation centre that will be producing vaccines for neglected diseases in Pune, India, where the company is based.
‘Kala-azar is a significant health problem across northern India and neighbouring countries,’ said Sanjay Singh, chief executive 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.’
Gennova will start producing the LEISH-F3 + GLA-SE vaccine later this year. It will then be tested in healthy Indian adults, in collaboration with the Banaras Hindu University in Varanasi, India.
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 LEISH-F3 + GLA-SE vaccine.