Meningitis vaccine trials to enter 2nd phase next year

The Pune-based Serum Institute of India (SII) will begin the second phase of human trials on the sub-dollar meningitis vaccine, developed by it, by mid to late 2006.

The institute has developed the vaccine under the Bill and Melinda Gates Foundation-supported Programme for Appropriate Technologies in Health (Path) for sub-Saharan Africa.

Scientists from the institute expect the vaccine to become commercially available by 2009, once it clears clinical trials. Said Akshey Goel, additional director, Serum Institute of India, who has been leading this vaccine initiative, "We tentatively expect the vaccine to be ready for commercial release provided it clears all the clinical trials."

It has already cleared the first stage of trials wherein it is checked for safety for human usage. In the second stage, it will be tested for its immune efficiency. The trials are being conducted in sub-Saharan Africa by Path's Meningitis Vaccine Program (MVP).

In 2003, Path had challenged vaccine manufacturers worldwide to come up with a sub-dollar vaccine to control meningitis epidemic in sub-Saharan Africa.

On an average, nearly 50,000 to 100,000 people die of meningitis in the region each year, with the number rising to a million in an epidemic year. The last meningitis epidemic in 1997 recorded over a million deaths in 10 African countries.

While polysacchride-based vaccines have been available for meningitis since early 90s, it is effective only in adults. But in infants, the main target population, its effectiveness has been suspect. Nisseria A, the bacterial strain prevalent in sub-Saharan Africa attacks infants.

Goel said, "We have decided to use conjugate technology to combine polysacchrides and protein, which has been found to be effective in infants."

Also, the vaccine is usually priced at around $50 per dose. Path's strategy has been to develop a vaccine which can be supplied at under a dollar per dose in the underdeveloped countries.

Although Goel declined to disclose the cost of vaccine development, he said using the conjugate technology has helped to bring down the cost of production. Annual demand worldwide for the sub-dollar vaccine has been estimated at 600 million doses. Path had given SII an initial contract for 25 million doses in June 2004.