ROCKVILLE, MD and RIXENSART, BELGIUM, 25 April 2001 - Screening of children has begun for the clinical trial of a promising malaria vaccine set to start early next month in The Gambia, West Africa. The trial is the first of a series of three planned in The Gambia through a partnership between the Malaria Vaccine Initiative at PATH (Program for Appropriate Technology in Health, a US-based nonprofit organization), and GlaxoSmithKline Biologicals (GSK), the world’s largest vaccine manufacturer. The Gambian clinical trial is the first concrete step in a new partnership between MVI and GSK. The Gambian unit of the U.K.’s Medical Research Council (MRC) will conduct the trial in Basse Santa Su, a region in the country’s northwest where malaria is endemic.
Today’s announcement comes on Africa Malaria Day, as declared last year by African Heads of State in the Abuja Declaration and Plan of Action. Malaria currently infects an estimated 300 to 500 million people. Another 2.3 billion are at risk of the disease, making development of a malaria vaccine a global health priority. Those most vulnerable to malaria are children under five years of age and pregnant women.
"These trials are an important step forward in creating a malaria vaccine for children in Africa," said Regina Rabinovich, MD, Director of the Malaria Vaccine Initiative at PATH. "Most of the more than one million people who die of malaria every year are African children under the age of five." No malaria vaccines have ever been tested and found successful in children.
"As we mark Africa Malaria Day, we are pleased to announce this major advance toward the goal of preventing malaria," said Jean Stéphenne, President and General Manager, GlaxoSmithKline Biologicals. "We are committed to delivering a vaccine that will protect African children from this devastating disease. These trials are a critical step in that process."
The first trial, which will involve approximately 90 children between six and eleven years of age, will test the safety and immune response of GlaxoSmithKline’s “RTS,S” vaccine. Pending positive results, two subsequent trials will test the vaccine in children between one and five years old. Researchers have already safely tested the vaccine in adult volunteers in the United States, Belgium, Kenya, and The Gambia. It demonstrated a 70 percent efficacy rate in protecting adults in The Gambia against infection over a short period of time, making it the world’s only malaria vaccine candidate to have shown that level of efficacy.
During the upcoming children’s trials, MRC investigators will encourage families to take the normally recommended malaria prevention measures. They will closely monitor the children for at least two malaria seasons, which coincide with the annual rainy season, and treat any child who contracts malaria. “Investigators at MRC/Gambia will carefully evaluate each child throughout the trial,” said Keith McAdam, Director of MRC/Gambia. “We are hopeful that the promising results from the adult trial will translate to a safe vaccine that will protect children for a longer period of time.”
Malaria is a parasitic infection transmitted through the bite of the Anopheles mosquito. Currently, no vaccine is licensed to protect against malaria. Anti-malarial drugs are available, but the parasite has consistently developed resistance to them, leaving millions vulnerable to the disease.
GlaxoSmithKline Biologicals, the world’s leading vaccine manufacturer, last year distributed over 1.1 billion doses of vaccines to 177 countries, an average of 35 per second. For information, visit GlaxoSmithKline’s vaccine Web site at www.worldwidevaccines.com. GlaxoSmithKline-one of the world's leading research-based pharmaceutical and healthcare companies-is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.
The Malaria Vaccine Initiative (MVI) at PATH seeks to accelerate the development of promising malaria vaccines and ensure their availability for the developing world. For further information about MVI and PATH, visit the Web sites at www.malariavaccine.org and www.path.org.
The Medical Research Council has worked in The Gambia for 50 years and has developed a strong relationship with the community and the government. As a result, more than 90 percent of Gambia’s children are immunized against the major childhood diseases-a slightly higher rate of immunization than in the United States. For further information about MRC, visit the Web site at www.mrc.ac.uk.
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