Bookmarkers beware: Bookmarks to pages other than the home page may not work after we change our server in April Editor's Choice | This Week in BMJ | Press releases BMJ No 7129 Volume 316 News Saturday 7 February 1998 India approves leprosy vaccine A vaccine against leprosy has been approved by India's drug control agency and is to be incorporated into the national eradication programme. The vaccine is designed to be used as an adjunct to standard multidrug therapy to accelerate healing and reduce the duration and cost of the treatment. The vaccine, developed at the National Institute of Immunology in New Delhi, is said to be the first in the world that stimulates the immune system to kill Mycobacterium leprae.The vaccine, administered intradermally, is prepared from a killed non-pathogenic strain of Mycobacterium,first isolated in the mid-1970s from the sputum of a patient with tuberculosis in Madras. "Patients who receive the vaccine and standard anti-leprosy multidrug treatment show faster clinical improvement and more rapid clearance of bacteria than those who receive only drugs," said Dr Rama Mukherjee, a senior scientist at the institute. Indian patients with leprosy receiving therapy Photo: SEAN SPRAGUE/PANOS PICTURES Whereas multidrug therapy using rifampicin and two other drugs takes 12-24 months, the vaccine will help to reduce duration of treatment by at least six months in the most severe cases, Dr Mukherjee said. "We expect this vaccine to provide a big boost to the leprosy eradication programme," said Dr Manju Sharma, secretary of India's department of biotechnology, which invested about 20 million rupees (£300,000; $480,000) in the project. Leprosy is prevalent across Asia, Africa, and Latin America, but India accounts for 60% of the global pool of patients with leprosy, estimated to be about one million in 1996. A fifth of patients are below the age of 18. The vaccine is based on the concept of "cross reacting antigens," in which the killed Mycobacterium strain is used to stimulate the immune system into mounting an attack on M leprae."This is possible because the two bacilli have cross reacting antigens," said Dr Mukherjee. The first commercial batch is expected to be released by June 1998 and will be sold in India at six rupees (10p) a dose. Health ministry officials, however, have expressed reservations about the impact of the vaccine in the leprosy eradication programme. "We don't see any real advantage of using this adjunct. Patients who are on standard multidrug therapy are not expected to actually feel any benefit from the faster clearance of the bacteria brought about by the vaccine. Drug treatment alone does lead to complete elimination of bacteria, although the process may be slower," said a senior official. Others argue that the vaccine has been known to cure the disease and clear bacteria within six months in some patients. "It will also help prevent reactivation of the disease in the most severe cases," said Gursaran Talwar, former director of the National Institute of Immunology. India is nowhere near eradicating leprosy with the current treatments available. Last year the health ministry detected 400,000 new cases. Institute scientists say that the immunoprophylactic role of the vaccine is also under investigation. Over the past eight years, nearly 23,000 healthy household contacts of patients with leprosy have received the vaccine, but the results of this study are not expected for another three years because of the long gestation period of the leprosy bacillus. Ganapati Mudur New Delhi Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline