Covance in Madison has started the first human trial of the first vaccine designed specifically for leprosy, an ancient disease that continues to sicken about a quarter of a million people worldwide each year.
Two dozen people are expected to take part in the phase 1 study, announced Thursday by the Infectious Disease Research Institute and American Leprosy Missions, developers of the vaccine called LepVax.
Covance, which conducts drug trials and food analysis in its research facility near the Dane County Regional Airport, is the only site involved in the initial study of the vaccine, said Lee Schoentrup, spokeswoman for the Seattle-based Infectious Diseases Research Institute.
If the vaccine is approved, it could treat leprosy — which persists mostly in Africa, Asia and Latin America — and prevent people who are exposed to the bacterium from developing the disease, which can leave people disabled, disfigured and blind.
“We believe this may be the most exciting breakthrough in leprosy treatment since multi-drug therapy, the current treatment for leprosy, was launched in the 1980s,” Bill Simmons, president and CEO of American Leprosy Missions, based in Greenville, South Carolina, said in a statement.
Dr. James Conway, associate director for health sciences at UW-Madison’s Global Health Institute, said drug treatment helps but leprosy still can be debilitating.
“It’s a significant problem, but it doesn’t move quickly or kill a lot of people, so it’s kind of off the radar,” Conway said.
In the study at Covance, healthy people ages 18 to 55 will be given three injections of the vaccine over two months, with some receiving a higher dose than others.
The study will assess the safety of the vaccine, as is routine, and participants’ immune response to it. Additional trials, involving more people and other sites, are expected to evaluate its efficacy.
There is no chance of getting leprosy from the vaccine because it doesn’t contain the bacterium that causes the disease, said Malcolm Duthie, a senior scientist at the Infectious Disease Research Institute.
Other vaccines tested for leprosy, including one being studied in India, have been developed primarily for tuberculosis or other diseases, Schoentrup said.
LepVax combines four proteins from Mycobacterium leprae, the bacterium that causes leprosy, with an immune-system stimulant, she said.
Representatives from Covance and its parent company, LabCorp, declined comment.
Leprosy, also called Hansen’s disease, can affect the nerves, skin, eyes and lining of the nose, according to the Centers for Disease Control and Prevention.
It can take up to 20 years to develop signs of the infection, according to the CDC.
If untreated, nerve damage can cause paralysis of the hands and feet. In advanced cases, people may have multiple injuries due to lack of sensation and the body may reabsorb affected digits over time, resulting in the apparent loss of toes and fingers, the CDC says.
About 200 people in the United States and 250,000 people around the world get the illness each year.
Leprosy was long feared as highly contagious but is actually hard to spread, the CDC says. However, in many places, sufferers are isolated and discriminated against.