MONDAY, SEPTEMBER 26, 2016

Malaria vaccine shows reduction of disease in Phase III study

GlaxoSmithKline, a research-based pharmaceutical company, announced on Tuesday that its malaria vaccine candidate showed continued protection of young children and infants from clinical malaria up to 18 months following vaccination.

The Phase III trial of RTS,S showed that the vaccine candidate nearly halved the number of malaria cases in young children aged five to 17 months at first vaccination and reduced by around a quarter the malaria cases in infants aged six weeks to 12 weeks at first vaccination. The study also found statistically significant efficacy at all sites in young children and at four sites in infants.

GSK and the PATH Malaria Vaccine Initiative are conducting the trial at 11 African research centers in seven African countries, with grant funding from the Bill & Melinda Gates Foundation.

"In Africa we experience nearly 600,000 deaths annually from malaria, mainly children under five years of age," Halidou Tinto, the principal investigator from the Nanoro, Burkina Faso-based trial site, said. "Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease."

The study found that over 18 months of follow up, 444 cases of clinical malaria were prevented for each 1,000 infants vaccinated. The reduction of severe malaria cases and hospitalizations of 15 percent to 17 percent was not considered statistically significant.

"It appears that the RTS,S candidate vaccine has the potential to have a significant public health impact," Tinto said. "Preventing substantial numbers of malaria cases in a community would mean fewer hospital beds filled with sick children. Families would lose less time and money caring for these children and have more time for work or other activities. And of course the children themselves would reap the benefits of better health."

GSK plans to submit a regulatory application for the vaccine candidate. If the application is successful, the biopharmaceutical company would be one step closer to using the vaccine candidate to fight malaria.

"We're very encouraged by these latest results, which show that RTS,S continued to provide meaningful protection over 18 months to babies and young children across different regions of Africa," Sir Andrew Witty, the CEO of GSK, said. "While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive."