The first vaccine against malaria is likely to be distributed in Africa from 2015 after the “milestone moment” of the continent’s largest final-stage drug trial, scientists have told The Times.

A meeting of 1,500 specialists in infectious disease will be told tomorrow that more than 5,500 children have been given the RTS,S vaccine, made by GlaxoSmithKline (GSK), the British pharmaceutical company, as part of the trial. Vaccine developers will tell the conference that the phase three trial is under way in seven countries around Africa, marking a major step in bringing the drug to licence.

Malaria is a parasitic disease that infects about 250 million people every year, resulting in almost a million deaths. It is caused by the Plasmodium parasite, which is passed to humans by infected mosquitoes when they bite. The disease can damage the nervous system, kidneys and liver, and severe cases can quickly lead to death.

About 40 per cent of the world’s population is at risk of malaria, mainly in the poorest countries.

The problem is especially serious in Africa, where one in every five childhood deaths is due to the effects of the disease. An African child has on average between 1.6 and 5.4 episodes of malarial fever each year, with one child dying every 30 seconds from the disease.

Delegates at this week’s conference in Nairobi will be told that although the vaccine will not be a “magic bullet” against the disease, the latest trials of RTS,S brings it within reach of regulatory approval.

Dr Joe Cohen, vice-president of vaccine research and development at GSK, and one of the inventors of RTS,S, said that initial data would be filed within the next 12 months, with trial results expected by 2012 and implementation by 2015.

“There is enormous excitement at reaching this milestone of this pivotal phase three trial. We are really forging ahead now,” he said. “We can see implementation starting broadly in 2015. Just a few years ago the idea of a malaria vaccine entering final phase three trials would have been unthinkable. It’s a tremendous breakthrough.”RTS,S, also known as Mosquirix, is the first potential malaria vaccine to make it to large-scale efficacy and safety trials, but also the first to target a more complex human parasite rather than a bacterium or virus.

The trials, which began in May, have now reached countries including Tanzania, Kenya, Malawi, Mozambique and Gabon. The vaccine has been given to between 5,000 and 6,000 children, and will eventually involve more than double the number.

Data from earlier trials of RTS,S, published last year, showed that it reduced the risk of malaria by 53 per cent in children aged between 5 months and 17 months. It was shown to be safe and tolerable and could be given alongside other vaccines.

Even a partially effective vaccine would have the potential to save hundreds of thousands of lives a year. However, since it is likely to be five years before it is in use, experts said that eradicating the disease would mean fighting on many fronts.

Essential elements include insecticides to spray bednets, building houses to deter mosquitoes and finding new drugs and funding existing ones. Global estimates suggested that $4.2 billion (£2.5 billion) would be needed each year to fight malaria.

Dr Ashley Birkett, director of preclinical development at the PATH Malaria Vaccine Initiative, the non-profit organisation, said that a rethink of funding strategies was needed, including the target of an 80 per cent effective vaccine by 2025. “With vaccine development you have to take a long-term approach,” Dr Birkett said. “RTS,S is the first step not only to preventing illness and death but ultimately to eradicating the disease.”

Counting the cost

• There are four types of human malaria: Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae and Plasmodium ovale. More than 90 per cent of cases are caused by Plasmodium falciparum, the most destructive malaria parasite, found mainly in Africa
• The common first symptoms — fever, headache, chills and vomiting — usually appear 10 to 15 days after a person is infected. If not treated promptly with effective medicines, malaria can cause severe illness and is often fatal
• The disease accounts for about 40 per cent of public health spending in sub-Saharan Africa, and malaria related-illnesses and mortality are estimated to cost Africa’s economy $12 billion a year Travellers from malaria-free areas to disease “hot spots” are especially vulnerable
Sources: World Health Organisation, the Malaria Vaccine

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