Largest-Ever Vaccine Trial Planned in Battle Against Malaria

By Stephen Mbogo | July 7, 2008 | 8:18 PM EDT

Nairobi, Kenya ( - Sixteen thousand children in Kenya and Tanzania and Mozambique will be involved in the largest-ever medical trial of its kind in Africa later this year, as developers of a vaccine for malaria carry out a final test following earlier successes.

Almost a million malaria deaths are recorded every year in sub-Saharan Africa, mostly among children. World Malaria Day is being marked around the globe on Friday.

A spokesman for GlaxoSmithKline, the principal developer of the vaccine, said here that two earlier rounds of trials had been successful. The company does not foresee major clinical obstacles when a third and final round is held later this year.

Dr. John Musunga, head of GSK in East Africa, said the trial, to begin in September, will involve 16,000 children, the largest number of people ever involved in a vaccine trial in Africa.

Other African countries could be included in the trial, which seeks to establish the effectiveness of the vaccine in different environments.

Musunga said it would take about three years to know the effectiveness of the vaccine, based on assessments of participants' responses.

The initiative involves scientists based at institutions including the School of Medicine at Moi University in Kenya. The vaccine will also be tested by public bodies responsible for regulating sales of pharmaceutical products in their respective countries before it can be made available commercially.

Earlier trials of the vaccine, involving some 200 young children in Mozambique in 2007, recorded a 65 percent cut in malaria cases, according to the Malaria Vaccine Initiative, the main body overseeing the trials.

GSK has partnered with the Bill & Melinda Gates Foundation to develop a vaccine for the killer disease. Musunga said the partnership would ensure that the eventual price of the vaccine is lower than it would have cost had GSK developed it on its own.

So far, the foundation had donated almost $260 million to the initiative.

Musunga said African governments had offered "moral support" to the project, rather than financial backing.

Doctors warn that even with a vaccine, other efforts to fight malaria deaths, such as providing mosquito-treated bed nets and spraying of potential mosquito breeding spots, should continue.

The American government currently is assisting 15 African countries to reduce malaria deaths through intervention strategies, including the provision of bed nets and the spraying of insecticides inside houses.

In 2005, President Bush launched the President's Malaria Initiative, a five-year $1.2 billion program aimed at helping selected nations to cut malaria-related deaths by 50 percent.

First Lady Laura Bush said on Capitol Hill Thursday that more than 25 million people already had benefited from the initiative in just its second year of operation.

Bed nets are the main contributors to a drop in malaria hospital visits by almost one-half in countries like Kenya, where according to government figures, 10 million such nets have been distributed since 2005.

Joyce Mageto, a mother of five living in Kenya's malaria-prone Kisii region, said since she started using nets in 2006, the differences were evident.

"I used to take my son to the hospital after every two weeks," Mageto said in a phone interview. "These days, we go for six months without a hospital visit."

Malaria was eradicated in the U.S. in the late 1940s and early 1950s through swamp drainage and spraying of the insecticide DDT, which was later banned by the Environmental Protection Agency at the insistence of environmental activists.

The World Health Organization in 2006 gave the thumbs-up to the use of DDT for indoor spraying in the fight against malaria, saying that out of 12 insecticides currently recommended, DDT is the most effective.

DDT is being used in at least 10 countries in sub-Saharan Africa.

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