GSK malaria vaccine boosted by Gates grant

The new project will expand clinical evaluation of the world’s most advanced malaria vaccine candidate, known as RTS,S. If all the project milestones are achieved, this agreement will take the vaccine through licensure and introduction to African immunization programs.

Most of the new grant will directly support clinical trials in Africa. From its own funds, GSK will at least match the $21.4 million it receives from MVI to help defray some of the clinical development costs.

A 2004 proof-of-concept trial in Mozambique found that the vaccine reduced severe malaria by 58 percent in children ages 1 to 4. The new trials will include studies to assess this promising vaccine candidate in younger age groups including infants, the groups that suffer most from malaria and that would benefit the most from an effective vaccine against the disease.

MVI and GSK Biologicals, which first entered into collaboration in 2000 to develop the vaccine for children, will launch small-scale trials in infants and young children and then proceed to a large-scale phase III clinical trial to determine the efficacy of the vaccine. The clinical trials will be conducted in several African countries.

“This is a key step toward development of the most promising malaria vaccine candidate,” said Jean Stephenne, president of GSK Biologicals, one of the world’s largest vaccine companies. “Approximately five years of work will be required before this vaccine is ready for licensure and implementation.”