PATH MVI Announcement: RTS,S malaria candidate vaccine reduces malaria by approximately one-third in African infants
Results from ongoing Phase III clinical trial announced
Results from a pivotal, large-scale Phase III trial, published online today in the New England Journal of Medicine [see Journal Watch below], show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. 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. In this trial, RTS,S demonstrated an acceptable safety and tolerability profile.
Eleven African research centres in seven African countries1 are conducting this trial, together with GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI.
Dr. Salim Abdulla, a principal investigator for the trial from the Ifakara Health Institute, Tanzania, said: “We’ve made significant progress in recent years in our battle against malaria, but the disease still kills 655,000 people a year—mainly children under five in sub-Saharan Africa. An effective malaria vaccine would be a welcome addition to our tool kit, and we’ve been working toward this goal with this RTS,S trial. This study indicates that RTS,S can help to protect young babies against malaria. Importantly, we observed that it provided this protection in addition to the widespread use of bed nets by the trial participants.”
PDF version of press release (139 KB PDF)
http://www.malariavaccine.org/pr2012Nov9-RTSS.php
MVI Director Dr. David Kaslow comments on malaria vaccine results
Posted on November 9, 2012 http://www.path.org/blog/2012/11/malaria-vaccine-comments/
WHO Announcement: New results from RTS,S/AS01 malaria vaccine trial
9 November 2012
WHO notes the completion of the latest stage of the RTS,S/AS01 Phase 3 malaria vaccine trial. As communicated previously, WHO will make evidence-based recommendations in 2015. These recommendations will be based on the full results from the Phase 3 trial that will become available in 2014, including the site-specific efficacy and booster dose data. WHO recommendations are based on the input of its independent advisors. For malaria vaccines, the Joint Technical Expert Group (JTEG) on malaria vaccines will draft candidate policy recommendations for joint review by the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) in 2015.
RTS,S/AS01 may have an important role in some settings in sub-Saharan Africa, depending on the results in 2014. RTS,S/AS01 will be evaluated as a possible addition to, and not a replacement for, existing preventive, diagnostic and treatment measures, depending on the results that become available in 2014.
Related links: Questions and Answers on Malaria Vaccines (November 2012)
pdf, 134kb
http://www.who.int/vaccine_research/diseases/malaria/new_results_malaria_vaccine_trial_rts-s-as01/en/index.html
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GAVI: Statement on latest interim trial data on malaria vaccine candidate
Latest interim trial data on malaria vaccine candidate RTS,S published by Glaxosmithkline and Path malaria vaccine initiative
In response to the release of the latest interim data on the trial of malaria vaccine candidate RTS,S, Dr Seth Berkley, CEO of the GAVI Alliance, said. “Malaria claims the lives of hundreds of thousands of children every year so evidence that it is scientifically possible to vaccinate children and babies against the disease and provide protection against malaria and severe malarial disease for a period of time is extremely significant. This is the first protozoa disease that we have convincingly been able to prevent in humans through immunisation.
“While the science is encouraging, today’s interim data showing lower efficacy of protection in infants at the age of the regular immunisation schedule as compared to previous results in older children raises questions from a public health perspective as this is the age group it would be most easy to distribute the vaccine to through the routine immunisation system and get maximum protection from the effects of malaria. More data on duration of protection using this and other vaccine schedules will be important to understand what the vaccination strategy can be and how an efficacious vaccine with a good duration of protection can be used in the relevant settings.
“GAVI is committed to making cost-effective investments in vaccines that protect the lives of the most vulnerable. We await the publication of the full trial results to understand the potential role of RTS,S in Malarial control. An efficacious malaria vaccine has the potential to change the lives of millions of people in some of the world’s poorest countries. A licensed vaccine would join bed nets, insecticide spraying and anti-malarial drugs as ways of protecting the most vulnerable from malaria.”
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