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Trials in Africa under way that could make malaria as rare as polio

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Wednesday, April 28, 2010

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Clinical Trials

NAIROBI -- Every 30 seconds, a child in Africa dies of malaria.

Parasite-carrying mosquitoes infect 250 million people living in the tropics each year resulting in one million deaths, according to the World Health Organisation. Africa, with 90 per cent of all malaria deaths, is the hardest hit region. Most deaths occur among low-income children under five years old.

The disease is preventable and curable, but there is currently no vaccine for malaria. However, researchers are testing a revolutionary vaccine that could make malaria as rare as polio, a disease that has nearly been eradicated. The drug tests were happening as the international community marked World Malaria Day on Sunday and pledged more funds to fight the disease.

GlaxoSmithKline, the British pharmaceutical company, the US Walter Reed Army Institute of Research and Path Malaria Vaccine Initiative are developing a drug called RTS,S or Mosquitrix, which could be commercially available in two years.

If successful, GlaxoSmithKline, known more for its lifestyle drugs for affluent people, could set a trend of biotech companies finding cures for diseases that plague the developing world. The malaria vaccine has been in the works for 20 years.

The Bill and Melinda Gates Foundation, which recently pledged US$10 billion (Dh36.7bn) to support vaccine development, is helping to fund the research of the malaria vaccine.

The disease is transmitted by a bite from an infected mosquito. The malaria parasites travel quickly to the liver, where they mature and enter the bloodstream.

Telltale symptoms begin with muscle aches and fatigue. Next come the chills and headache followed by nausea and loss of appetite. At this point, if left untreated, children can lapse into a coma and often die.

Simple prevention of malaria includes mosquito nets, insect repellent and removing standing water, where mosquitoes breed. Malaria prophylaxes are available, but are often too expensive for people in the developing world. Side effects are also common.

The third phase of the vaccine’s trial is underway in seven African countries and involves 16,000 children in malaria-affected nations. If the drug is proven effective and safe, GlaxoSmithKline will seek regulatory approval in 2012.

“A malaria vaccine could help save countless lives and redefine the future for Africa’s children,” said Patricia Njuguna, one of the vaccine’s lead investigators based in Kenya. “Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile.” The second phase of the RTS,S trial, conducted on 2,000 children in Mozambique, showed that the drug reduced malaria by 53 per cent. The current clinical trial is the largest test of a malaria vaccine in the world.

“This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa,” said Joe Cohen, the co-inventor of RTS,S. “The Phase III trial is a huge undertaking. Everyone involved has invested significant energy and resources to pave the way for what could become the world’s first malaria vaccine.”

Subsidising the development of the vaccine is key to making it affordable to the world’s poor. Experts say a drug like this needs to be made widely available to target those most in need.

“Development is only half the mission,” said Christian Loucq, the director of the Path Malaria Vaccine Initiative, which is based in the United States. “MVI and its partners are committed to ensuring this vaccine reaches those who need it most. We hope the international community will respond by starting to prepare for the day when, if all goes well, this vaccine will be available for distribution and use.”

GlaxoSmithKline says the vaccine will be made affordable in developing countries. Andrew Witty, the chief executive of GlaxoSmithKline, said the company would not look to make a large profit on the drug, although a final price has not been determined.

“We want to be responsible,” Mr Witty said in a speech in January to the Council on Foreign Relations, a US foreign policy think tank. “That’s why what we will do is set a price that covers our costs and generates a small return. A small return, all of which will be ploughed back into research and development for next-generation malaria vaccines and vaccines against other neglected diseases.”

On Sunday, the third World Malaria Day, Ban Ki-moon, the UN secretary general, praised the efforts to eradicate the disease. “Strong commitment has sparked innovation,” Mr Ban said. “Groundbreaking partnerships are developing new malaria medicines and making existing medicines more accessible and affordable. The challenge now is to ensure that all who are exposed to malaria can receive quality-assured diagnosis and treatment. The advances of recent years show that the battle against malaria can be won.”

But experts caution that the private sector cannot win the battle against malaria alone. Politicians and governments need to step up to see that the vaccine becomes a reality.

“I urge our leaders to now match our advances in research with similar advances in public health capacity and the political will required to widely implement the first ever malaria vaccine,” said Tsiri Agbenyega, who heads a committee that oversees the vaccine’s clinical trials. “We can make the promise of a malaria vaccine a reality if we maintain the momentum of this Phase III trial and begin to plan for the future.”

 

© Copyright of Abu Dhabi Media Company PJSC

Author: By Matt Brown
Source: The National
1.0 from 1 vote
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