PATH Malaria Vaccine Initiative (MVI)
The PATH Malaria Vaccine Initiative (MVI) was launched in 1999 to accelerate development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI was funded by a USD 50 million grant from the Bill & Melinda Gates Foundation and the Initiative is administered by the US not-for-profit Program for Appropriate Technology in Health (PATH. MVI is guided by Technical Advisory Groups, a Strategic Advisory Council and PATH’s board. Partners include malaria experts around the world, government agencies, academia, public and private research institutions, and vaccine producers.
GSK’s candidate RTS,S/AS, in development for more than 15 years, is the only malaria vaccine so far to demonstrate significant efficacy in young children and infants. A trial in 2,000 children in Mozambique in 2004 showed it to be effective for up to 18 months, reducing clinical malaria by 35% and severe malaria by 49%. The candidate vaccine has a promising tolerability and safety profile, and is intended specifically for use in Africa. GlaxoSmithKline’s GSK Biologicals has so far spent some USD 300 million on malaria vaccine development.
Several more years of clinical investigation will be needed. A Phase II trial is evaluating the optimal adjuvanted formulation and suitability of the vaccine when administered with national immunization schedules (WHO Expanded Program on Immunization EPI).
RTS,S/AS is indeed expected to enter Phase III trials in Africa in late 2008, with 16,000 infants and young children between the ages of 6 weeks and 17 months of age in 10 sites in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. This could become the largest vaccine clinical trial ever conducted in Africa. All children in the phase III trials will be followed for safety and efficacy for at least two years.
The Bill & Melinda Gates Foundation has announced a new grant to MVI, primarily to support the phase III clinical trial. GSK will at least match from its own funds the USD 21.4 million it receives from MVI, to help defray some of the clinical development costs.