Malaria vaccine trial to start next year

Tamar Kahn | 11 Nov 2008
Business Day (South Africa)
CAPE TOWN — Scientists hoped to start final tests on the world's most advanced malaria vaccine early next year, they said yesterday.

The trial is expected to involve more than 16000 babies at 11 sites in seven African countries, and will be one of the biggest conducted in Africa.

Malaria is caused by a mosquito-borne parasite, and is among Africa's most devastating diseases. Scientists hope the vaccine will work against all strains of malaria, including those found in southern Africa, where the disease kills about 250000 people a year, mostly children younger than five.

The candidate vaccine, called RTS,S, was developed by GlaxoSmithKline Biologicals (GSK Bio) and the US Walter Reed Army Research Institute.

Previous research, published last year, showed the shot reduced the risk of malaria infection in babies by 65% and cut the number of cases of full-blown malaria by 35%. An earlier study showed the jab was safe and offered some protection to slightly older children, aged between one and four.

GSK Bio and its partners are now finalising arrangements for the last testing stage, a phase III trial that will determine the extent to which the vaccine protects babies from malaria among two key groups: one-third of the babies will get three shots at monthly intervals from the age of six weeks, in conjunction with the jabs they are due to get as part of national immunisation programmes. The rest will get their shots when they are aged between five and 17 months, as many babies do not get all their routine jabs.

"This is the pivotal trial that will generate the kind of data we need to apply for registration with the regulatory authorities," said GSK Bio vice-president Joe Cohen, one of the vaccine's co-inventors. If the trial is successful and if the vaccine is approved by regulatory agencies, it could be available by 2012 .

The vaccine prompts the body to make antibodies that attack the plasmodium falciparum parasite as soon as it enters the blood stream, as well as triggering T-cells to attack any parasites that enter the liver.