Mumbai, Oct 2 (Inditop.com) A clinical trial to test the safety and efficacy of a newly-developed anti-rabies antibody has got underway here.
The antibody, known as human monoclonal antibody (MAB), used to neutralise the rabies virus, has been developed by MassBiologics of Massachusetts University Medical School (MB-MUMS), working with the Serum Institute of India.
The trial’s first phase, in which 84 healthy volunteers will receive various doses of the new MAB, is being conducted at the King Edward Memorial Hospital in Mumbai, sponsored by the Serum Institute of India (SII), which is collaborating with MB-MUMS.
The SII is a major supplier of the rabies vaccine.
“India is an appropriate location to do this study because of the serious problem of rabies that exists in the country,” said Donna Ambrosino, executive director of MassBiologics and professor of paediatrics at MUMS.
“Too often physicians in India and other developing countries only have the rabies vaccine to offer, and that alone isn’t always enough to prevent infection,” said Deborah Molrine.
Molrine is the deputy director of clinical and regulatory affairs at MassBiologics, who helped design the clinical trial and will oversee the analysis. “If this new antibody proves effective in people, it will have a tremendous impact on saving lives,” she said.
Worldwide, rabies remains a major public health problem. The World Health Organisation estimates that at least 10 million people are exposed to rabid animals each year, resulting in some 55,000 deaths.
The rabies virus can cause acute encephalitis that is fatal once symptoms appear; however the infection is preventable by prompt treatment following exposure.
By using a rabies vaccine and human rabies immune globulin (hRIG) soon after exposure, patients are protected from the fatal disease.
Unfortunately, hRIG, which is derived from human blood, is expensive and is often not available in developing countries, said MB-MUMS.
To compensate, equine immune globulin derived from horse serum is used in many parts of the world, but it also can be scarce and can carry significant side effects.
