Washington, Nov 4 (ANI): The world's largest trial of one of the leading malaria vaccine candidates, called RTS,S, is now underway 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, according to researchers.
GlaxoSmithKline Biologicals' (GSK Bio) 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 (MVI) to develop a malaria vaccine.
"A malaria vaccine could help save countless lives and redefine the future for Africa's children.
Communities all across Africa are dedicated to this future and are participating to ensure that we develop a vaccine with an acceptable safety and efficacy profile," said Dr. Patricia Njuguna, RTS,S principal investigator and chair of the Clinical Trials Partnership Committee.
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 the age of five.
Conducting the trial in seven different countries across Sub-Saharan Africa would help researchers 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.
All of the research centres were chosen for their track record of world-class clinical research, strong community relations and commitment to meeting the highest international ethical, medical, clinical and regulatory standards.
"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. 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," said Dr. Joe Cohen, co-inventor of RTS,S.
Recent Phase II studies showed that RTS,S reduced clinical episodes of malaria by 53 percent over an eight-month follow-up period.
The Phase III trial will evaluate the vaccine's efficacy in two groups of children. One group, aged 6 to 12 weeks, will be vaccinated as part of their regular schedule of infant immunizations; the second group includes children aged 5 to 17 months.
The vaccine profile is intended primarily for infants, as they and children under the age of five are the most vulnerable to malaria.
The researchers announced the trial on Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference. (ANI)