In a proof-of-concept study to be published this week in The Lancet, researchers report that GlaxoSmithKline (GSK) Biologicals' RTS,S/AS02A malaria vaccine candidate protected a significant percentage of children against uncomplicated malaria, infection, and even severe forms of the disease for at least six months. This largest malaria vaccine efficacy trial ever conducted in Africa also re-confirmed the vaccine's safety in one-to-four year old children. Further efficacy studies will be needed before consideration for licensure.
The double-blind, controlled trial involved 2,022 children in southern Mozambique and was conducted by the CISM. GSK Biologicals and Path's Malaria Vaccine Initiative (MVI) co-sponsored the trial, which was approved by Mozambique's Ministry of Health.
"Our results demonstrate the feasibility of developing an efficacious vaccine against malaria," wrote CISM's Pedro Alonso, lead author of the Lancet article, adding that "malaria vaccines could greatly contribute to reducing the intolerable global burden of this disease." Dr. Alonso was the principal investigator of the study and heads the Center for International Health of the Hospital Clinic at the University of Barcelona.
Mozambique's Minister of Health, Dr. Francisco Songane, said his nation was proud to be a part of such a groundbreaking study. "Malaria is the number one killer of African children. We did this not only for the people of Mozambique, but for the people all over Africa whose health and development suffer greatly from this terrible disease."
"It will still take some years before this vaccine becomes a reality, but the commitment is certainly there," said Jean Stéphenne, president and general manager of GSK Biologicals, one of the world's largest vaccine companies. "We are very encouraged by these results. They demonstrate that a Plasmodium falciparum malaria vaccine based on the circumsporozoite protein is feasible. Such a vaccine could have a major impact on public health. This project demonstrates the power of collaboration between the public and private sectors," he added.
"There was a lot of skepticism about our approach in the scientific community," recalled Joe Cohen, Ph.D., Director, Emerging Diseases, HIV & Therapeutic Vaccines R&D at GSK Biologicals, who is co-inventor of the vaccine. "We're dealing with a very complex parasite that goes through different life stages in the human host. But we were highly committed and kept at it for over 15 years."