The phase I trial is taking place in Washington state, while a companion phase I trial is being planned in India—an epicenter of VL, which destroys white and red blood cells and if left untreated has a 90% case fatality.
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.
"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. "For the first time, an advanced vaccine to prevent this devastating disease is being tested in people."
The U.S. phase I clinical trial will consist of 36 adult volunteers 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 Indian phase I trial will be led by Gennova in collaboration with the Banaras Hindu University in Varanasi, India, in the former’s new, neglected-disease vaccine formulation center. Beginning later in 2012, Gennova will produce the LEISH-F3 + GLA-SE vaccine using IDRI technology and then begin testing in healthy Indian adults.
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. IDRI believes only such large trials, conducted in real-life situations of disease exposure, will determine the full effectiveness of the LEISH-F3 + GLA-SE vaccine.
