- Results published yesterday in the 'New England Journal of Medicine' revealed that tests of a malaria vaccine made in Kenya and Tanzania showed it provided both infants and young children with significant protection against the mosquito-borne disease. The vaccine could hit the market by 2011.
Two separate phase II trials reaffirmed earlier study results and supported the ongoing efforts, pending regulatory approvals, to launch the phase III study of GlaxoSmithKline's vaccine candidate across Africa. According to GlaxoSmithKline, this makes it the "world's most clinically advanced malaria vaccine candidate."
In infants, data show for the first time that the vaccine candidate could be administered as part of existing African national immunisation programmes. In children aged 5 to 17 months, the candidate reduced the risk of clinical episodes of malaria by 53 percent over an eight-month follow-up period and was shown to have a promising safety profile.
Malaria kills almost one million people each year - most of them infants and young children in Africa, the intended recipients for this vaccine candidate.
"Today's study results strongly show that our investments in developing malaria vaccines are beginning to pay dividends," said Christian Loucq of the US pharma giant. "We are closer than ever before to developing a malaria vaccine for children in Africa. History has shown that vaccines are the most powerful tool to control and eliminate infectious diseases. Clearly, the world urgently needs a safe and effective vaccine to win the war against this terrible disease," he added.
The infant study enrolled 340 children under 12 months of age in Tanzania and found that the vaccine, when administered at 8, 12, and 16 weeks of age with a commonly used childhood vaccine, did not interfere with other vaccines. In countries where a malaria vaccine is needed most, the current immunisation schedule by the WHO for infants "would provide an optimal delivery platform," GlaxoSmithKline said.
Additionally, the study reported 65 percent reduction against first infection from malaria in those infants who received three doses of the vaccine and were followed over a six-month period. Earlier studies found a similar level of efficacy for the malaria vaccine.
The other trial enrolled 894 children 5-17 months old in both Kenya and Tanzania. It was designed to evaluate the safety and efficacy of the vaccine. The study was a double-blind randomised clinical trial in which children received either three doses of the malaria vaccine candidate or a rabies vaccine.
It found that the vaccine reduces clinical malaria episodes by 53 percent for up to an average of eight months. Earlier studies in Mozambique demonstrated 35 percent efficacy against clinical disease for 18 months among children 1–4 years old.
"These findings build a solid case for phase III testing, which the partners in this endeavour are looking forward to starting in the near future," said Philip Bejon of Kenya Medical Research Institute (KEMRI), the study's lead author.
These results also make the GlaxoSmithKline vaccine the first one to make it this far in clinical testing. If also further studies are successful, marketing approval could be sought as early as 2011, the company indicates. "Given the magnitude of malaria in Africa, the results represent a major milestone," said Ally Olotu, noted one of the researchers from Kilifi, Kenya.
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