NAIROBI, KENYA — A pivotal efficacy trial of RTS,S, the world’s most clinically advanced malaria vaccine candidate, is under way in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Nov. 3 at the fifth Multilateral Initiative on Malaria Pan-African Malaria Conference.
Developing a vaccine against malaria, a scientific challenge for decades, is critical to defeating the disease. A vaccine would complement existing interventions, such as bed nets and effective drug therapies. GlaxoSmithKline Biologicals’ RTS,S is the first malaria vaccine candidate to demonstrate significant 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 to develop a malaria vaccine.
"This historic trial could lead to the availability of a vaccine with the potential to save the lives of hundreds of thousands of African children, if the data are positive," said Dr. Christian Loucq, director of the PATH Malaria Vaccine Initiative. “But development is only half the mission; MVI and its partners are committed to ensuring this vaccine reaches those who need it most. We hope the international community will respond by starting to prepare for the day when — if all goes well — this vaccine will be available for distribution and use.”
RTS,S is the first vaccine designed primarily for use in Africa, where malaria kills more than 800,000 people every year, the majority of them children under age 5.
By conducting the trial in seven different countries across sub-Saharan Africa, researchers will be able to evaluate the vaccine candidate’s efficacy in a variety of settings, with diverse patterns of malaria transmission. For example, some trial sites are located in areas where there is a year-round threat of malaria, while others experience only seasonal transmission.
“This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa,” said Dr. Joe Cohen, co-inventor of RTS,S at GSK Biologicals.