A pivotal efficacy trial of GlaxoSmithKline Biologicals’ (GSK), RTS,S is underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial is expected to involve up to 16,000 children, where more than 5,000 children already enrolled.
All of the research centers were chosen for their track record of clinical research, strong community relations and commitment to meeting the highest international ethical, medical, clinical and regulatory standards.
GSK claimed that it is the first malaria vaccine candidate to demonstrate efficacy during early development to warrant Phase III testing. It is the leading vaccine candidate in the global effort by the PATH Malaria Vaccine Initiative (MVI) to develop a malaria vaccine.
Joe Cohen, co-inventor of RTS,S and vice president of R&D, vaccines for emerging diseases and HIV, at GSK Biologicals, said: “The Phase III trial is a huge undertaking that depends on effective coordination between researchers, regulators, families and communities. Everyone involved has invested significant energy and resources to pave the way for what could become the world’s first malaria vaccine.”