With close to 800 000 deaths each year, most of whom are children in sub-Saharan Africa, the first results of phase 3 trial of RTS,S/AS01 vaccine against malaria has brought about hope in protecting children and expecting mothers who are mostly vulnerable to the disease, if the results released on Tuesday are anything to go by.
During the past decade, the scale-up of malaria-control interventions has resulted in considerable reductions in morbidity and mortality associated with malaria in parts of Africa However, malaria continues to pose a major public health threat.

The RTS,S vaccine that targets the circumsporozoite protein and is given with an adjuvant system (AS01 or AS02) has consistently shown protection against Plasmodium falciparum malaria in children and infants in phase 2 trials.

The vaccine had an acceptable side-effect profile and was immunogenic in children who were 6 weeks of age or older. The vaccine could also be administered safely with other childhood vaccines and provided protection against severe malaria.

The trial conducted at 11 sits in seven countries across sub-Saharan Africa showed that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56 percent and 47 percent respectively.

This analysis was performed on data from the first 600 children aged 5 to 17 months, over a 12 month period following vaccination.

The results further show that the analysis of severe malaria episode indicates that there is 35 percent efficacy over a follow-up period ranging between 0 and 12 months.

On safety, the results show that the overall incidence of serious adverse events in the trial was comparable about the RTS,S candidate vaccine with 18 percent recipients and 22 percent for those receiving a control vaccine.

Billionaire philanthropist Bill Gates, who helped fund the research, called it a "huge milestone" and said the vaccine could be ready by 2015 if further study results are positive.

GlaxoSmithKline CEO Andrew Witty discusses why the drug maker has devoted time to researching a malaria vaccine for children in Africa-and why he believes his company has a soul.

To stimulate an immune response to the malaria parasite, the vaccine combines the surface protein that helps the parasite invade liver cells with a protein found in a hepatitis B vaccine.GlaxoSmithKline PLC researchers began working on the vaccine in the late 1980s, in collaboration with the Walter Reed Army Institute of Research in Silver Spring, Md.

Nearly $500 million has been spent developing the vaccine by the Gates Foundation, Glaxo and the U.S. government, Gates said in an interview. If it "continues to show a long-term effect in the 40-50% range, then it has the potential to protect millions of children and save thousands of lives," Gates said in his public remarks.

It isn't clear how much the vaccine would cost. Glaxo has said it plans to sell it at a profit of 5% over the cost of making it, and that it will invest the profit in research and development for malaria and other neglected diseases. Glaxo officials said discussions soon will begin with global donor groups about potentially paying for the vaccine.

In Malawi, the total of 1682 children enrolled in this study with 804 from age 5 to 17 months and 826 from 6 to 12 weeks age groups.

"The results give hope to everyone because the mothers and children who rushed to central hospitals, some of them unconscious and sweating are so many. People are now starting to appreciate that there is light at the end of the tunnel," said Professor Francis Martinson, country Director for University of North Carolina (UUNC) project.

On affordability of the vaccine once the trials are completed and accepted by Word Health Organisation, he said they will make sure that everyone has access to it regardless of economic difficulties.

Malaria and anaemia which is usually attributed to malaria infection, is estimated to be responsible for about 40 percent of under five hospitalization and 30 percent of all hospital deaths with plasmodium falciparum accounting for 98 percent of the infections responsible for severe malaria disease and death, according to UNC project.
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