A Phase III trial of the world’s most clinically advanced malaria vaccine candidate was launched in Kisumu, Kenya, in July 2009, under the auspices of the Kenya Medical Research Institute (KEMRI)/CDC Research and Public Health Collaboration.
KEMRI/CDC and other research centers that were selected to oversee the trials in 11 sites in 7 African countries were chosen for their record of world-class clinical research, strong community relations, and commitment to meeting the highest international ethical and regulatory standards in conducting research.
If proven effective, the vaccine will complement existing interventions, such as insecticide-treated bed nets, indoor residual spraying, and effective drug therapies, to help prevent death due to malaria. Malaria kills approximately 900,000 people a year worldwide, most of them children living in sub-Saharan Africa.
The vaccine candidate—GlaxoSmithKline Biologicals' (GSKBio) RTS,S—is the first of the current generation of malaria vaccines to warrant Phase III testing on this scale. The vaccine has a promising safety profile, was more than 50% effective in reducing episodes of clinical malaria in children 5 to 17 months old in earlier testing, and can be administered together with the package of vaccinations routinely given to African children.
The vaccine has been in development since the mid-1980s and has advanced as far as clinical trials thanks to a unique public-private partnership of GSKBio, the PATH Malaria Vaccine Initiative, and African and other research organizations, with funding support from the Bill and Melinda Gates Foundation.
Phase III Trials and Beyond
This Phase III trial will demonstrate how the vaccine performs in two groups of children—one aged 6 to 12 weeks and a second aged 5 to 17 months—in different transmission settings across a wide geographic region in Africa.
In Phase II testing, the vaccine reduced cases of malaria in young children 5 to 17 months by 53%. If Phase III results are as good, the vaccine could be fully available in the next 5 - 10 years.
Vaccine partners are already working with malaria-affected countries and international institutions to ensure that a successful malaria vaccine will be available and affordable for those who can most benefit.
More on: Malaria Vaccines