A phase III trials of a malaria vaccine candidate developed by GlaxoSmithKline Biologicals and the Walter Reed Army Institute of Research is set to begin at 11 sites in seven African countries early next year.
The PATH Malaria Vaccine Initiative will conduct the trial involving 16,000 infants in clinics and research centres in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.
The trial will examine the extent of protection the vaccine candidate, called RTS,S, offers among infants.
One-third of the infants will receive three immunisations at monthly intervals beginning at the age of six weeks, in conjunction with other routine immunisations.
The remaining infants will receive the malaria vaccine candidate between the ages of five months and 17 months, not necessarily in conjunction with other routine shots.
According to Malaria Vaccine Initiative (MVI) Director, Christian Loucq, the project over the past year has upgraded laboratory equipment and computers, trained technicians and helped develop local equivalents to FDA to ensure the trial is monitored properly.
GSK has spent $300 million on the project so far and estimates it will contribute up to $100 million more. MVI, which is funded by the Bill & Melinda Gates Foundation, has spent $107 million so far and has not yet determined how much additional money it will spend.
Regardless of the vaccine’s success, the investment for the trials will improve communications, research and other infrastructure in the targeted areas of Africa, which could contribute to the search for other vaccines against diseases such as HIV/AIDS, according to researchers involved in the project.
Early trials of RTS,S, conducted since 2003 among 4,000 children, found the vaccine candidate was at least 30 percent effective against mild malaria cases and about 50 percent effective against severe malaria.
In addition, research published last year indicated that the vaccine reduced malaria risk among infants by 65 percent and reduced the number of active malaria cases by 35 percent.
The vaccine also has been shown to be safe and offer some protection for children ages one to four .