The world’s first malaria vaccine could be approved for use in 2015, experts say.
Reporting in PLOS Medicine, researchers found that for every 1,000 children who received the vaccine, an average of 800 cases of illness could be prevented.
In continuing trials it went on to provide protection some 18 months after the injections were given.
GlaxoSmithKline have now applied for regulatory approval – making this the first vaccine to reach this step.
Malaria affects millions of people worldwide and results in 800,000 deaths each year – the majority in children under five who live in sub-Saharan Africa.
The world’s first malaria vaccine could be approved for use in 2015
In the most advanced trial to date, involving several African countries, 1,500 infants and children were given the RTS,S vaccine.
Revisiting them 18 months after the last injection, researchers found that in young children the vaccine almost halved the number of cases of malaria.
For infants, who were aged six to 12 weeks at first vaccination, the drug reduced episodes of malaria by a quarter.
Though the effectiveness of the vaccine was seen to wane over time, the report suggests it may have the largest impact in areas with high rates of disease.
For example, in some Kenyan cities, 2,000 cases of clinical malaria were prevented for every 1,000 children who received the drug (people in this area are at risk of repeated infections).
GSK has now asked the European Medicine’s Authority to approve it for global use.
The drug-makers say together with other preventative measures such as bed nets and insecticides, this could represent a huge step forward in malaria control.
Scientists are investigating whether a booster could further improve the chances of success.
GSK is developing RTS,S with the non-profit Path Malaria Vaccine Initiative, supported by funding from the Bill & Melinda Gates Foundation.
US researchers say a malaria vaccine has shown promising results in early stage clinical trials.
Researchers found the vaccine protected 12 out of 15 patients from the disease, when given in high doses.
The method is unusual because it involves injecting live but weakened malaria-causing parasites directly into patients to trigger immunity.
The research is published in the journal Science.
Lead author Dr. Robert Seder, from the Vaccine Research Center at the National Institutes of Health, in Maryland, said: “We were excited and thrilled by the result, but it is important that we repeat it, extend it and do it in larger numbers.”
It has been known for several decades that exposure to mosquitoes treated with radiation can protect against malaria.
The new vaccine involves injecting live but weakened malaria-causing parasites directly into patients to trigger immunity
However, studies have shown that it takes more than 1,000 bites from the insects over time to build up a high level of immunity, making it an impractical method of widespread protection.
Instead, a biotech company called Sanaria has taken lab-grown mosquitoes, irradiated them and then extracted the malaria-causing parasite (Plasmodium falciparum), all under sterile conditions.
These living but weakened parasites are then counted and placed in vials, where they can then be injected directly into a patient’s bloodstream. This vaccine candidate is called PfSPZ.
To carry out the Phase-1 clinical trial, the researchers looked at a group of 57 volunteers, none of whom had had malaria before.
Of these, 40 received different doses of the vaccine, while 17 did not. They were then all exposed to the malaria-carrying mosquitoes.
The researchers found that for the participants not given any vaccine, and those given low doses, almost all became infected with malaria.
However for the small group given the highest dosage, only three of the 15 patients became infected after exposure to malaria.
Dr. Robert Seder said: “Based on the history, we knew dose was important because you needed 1,000 mosquito bites to get protection – this validates that.
“It allows us in future studies to increase the dose and alter the schedule of the vaccine to further optimize it. The next critical questions will be whether the vaccine is durable over a long period of time and can the vaccine protect against other strains of malaria.”
He added that the fact that the vaccine had to be injected into the bloodstream rather than into or under the skin made delivery more difficult.
There are currently about 20 malaria vaccine candidates in clinical trials.
The most advanced is called RTS,S/AS01, which has been developed by the pharmaceutical company GlaxoSmithKline, and is in a Phase-3 clinical trial involving 15,000 children in Africa.
According to the latest figures from the World Health Organization, there were an estimated 219 million cases of malaria in 2010 and an estimated 660,000 deaths.
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