The world may soon have its first vaccine against malaria. Results of Phase II human trials of the world’s most clinically advanced malaria vaccine candidate – called RTS,S/AS -- was found to offer protection to both babies and young children in Africa, reports the New England Journal of Medicine.
In children aged 5 to 17 months, the vaccine reduced malaria risk by 53 per cent over an eight-month follow-up period and was found to be safe. In babies, the vaccine candidate can be administered as part of the routine immunisation programmes.
Now that two separate phase II trials have reaffirmed safety and effectiveness, the launch the phase III study of GlaxoSmithKline (GSK) Biologicals’ RTS,S/AS vaccine candidate across Africa are expected to begin early next year, pending regulatory approvals.
Malaria kills almost one million people each year – mostly young children – with over 90 per cent deaths occurring in Africa.
The studies were conducted in Kenya and Tanzania and were presented today at the American Society for Tropical Medicine and Hygiene annual meeting in the US.
RTS,S/AS is the leading candidate in a global effort coordinated by the PATH Malaria Vaccine Initiative (MVI) to develop a malaria vaccine.
“Today’s study results strongly show that our investments in developing malaria vaccines are beginning to pay dividends,” said Christian Loucq, MVI director, said in a statement. “We are closer than ever before to developing a malaria vaccine for children in Africa.”
The vaccine works alongside standard infant vaccines of WHO’s Expanded Programme of Immunizsation, consistently shown to be safe and effective. “We can begin to foresee the difference this scientific breakthrough could make in the lives of millions of African children who suffer and die from this disease year after year,” said Joe Cohen, a co-inventor of the vaccine and vicepresident of Research & Development, Emerging Diseases & HIV at GSK Biologicals.
The vaccine candidate was developed with a US$107.6 million grant from the Bill & Melinda Gates Foundation to MVI. GSK has invested approximately $300 million to date and expects to invest another $50-100 million before the completion of the project.
The clinical development of RTS,S/AS is led by the Clinical Trial Partnership Committee, a collaboration of leading African research institutes, Northern academic partners, MVI and GSK with support from the Malaria Clinical Trial Alliance.