Trials show RTS, S Malaria Vaccine Candidate Reduces Malaria in African Infants
By Otieno Owino
Results from a large scale Phase III trial on RTS, S Malaria vaccine published online in the New England Journal of Medicine show that RTS, S malaria vaccine candidate can help protect African infants against malaria.
These findings have been officially released today November 9, 2012 at the International African Vaccinology Conference in Cape Town, South Africa.
When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS, S had one third fewer episodes of both clinical and severe malaria and had similar reactions to the injection. RTS, S therefore, demonstrated an acceptable safety and tolerability profile.
This trial is conducted by eleven African research centers together with GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI) with grant funding from Bill and Melinda Gates foundation to MVI
Dr. Salim Abdulla, a principal investigator for the trial from Ifakara Health Institute Tanzania, said: “We have made significant progress in recent years in our battle against malaria but the disease still kills 655000 people per year- mainly children under the age under the age of five in Sub-Saharan Africa. An effective malaria vaccine would be a welcome addition to our tool kit and we’ve been working towards this goal with this RTS, S trial. This study indicates that RTS, S can help protect young babies against malaria.”
The efficacy of RTS, S in infants aged 6 to 12 weeks (at first vaccination) against clinical and severe malaria was 31% and 37% respectively over 12 months of follow up after the third vaccine dose when administered along with standard childhood vaccines. The efficacy observed with RTS, S last year I children aged between 5-17 months of age against clinical and severe malaria was 55% and 47% respectively. Follow up study in phase III trial is expected to provide more data to better understand the different findings in the age categories.
Sir Andrew Witty, CEO, GSK said: “We believe these results confirm that RTS, S can help provide African babies and young children with meaningful protection against malaria. They take us another step forward on the journey towards having a new intervention available against the disease which is a huge burden on the health and economic growth of Africa.”
The vaccine is being developed in partnership with GSK and MVi together with prominent research centers in Kenya, Gabon, Ghana, Burkina Faso Malawi, Mozambique and Tanzania.
David Kaslow, Director of Path Malaria Vaccine Initiative said: “Determining the role of RTS, S in Africa will depend on analyses of additional data. We are now an important step closer to that day. Success in developing malaria vaccines depends on factors such as robust evidence coupled with an understanding that different combinations of tools to fight malaria will be appropriate in different settings in malaria endemic countries.”
More data on longer term efficacy of the vaccine during 30 months follow up after the third dose, and the impact of a booster dose are expected to be publicly available at the end of 2014.