Malaria vaccine trials launched in high risk regions
Posted Monday, July 20 2009 at 00:00
The third phase trial of the world’s most clinically advanced malaria vaccine candidate, known as RTS,S has been carried out in Kenya.
The first dose was administered at the Siaya District Hospital last week under the auspices of the Kemri/CDC Research and Public Health Collaboration.
The Kenyan launch follows the initiation of the Phase III trial in Tanzania in May. Two other sites in Kenya, KEMRI/Walter Reed Project in Kombewa, and KEMRI-Wellcome Trust Program in Kilifi, expect to start the Phase III trial in the coming months.
GlaxoSmithKline Biologicals, which developed and manufactures the vaccine, and the PATH Malaria Vaccine Initiative (MVI) are sponsoring Kemri/CDC and scientists across Kenya to conduct the trial. It is expected to enrol up to 16,000 children and infants in six other countries throughout Africa.
Speaking after the administration of the first vaccination at Siaya District Hospital, Dr Mary Hamel, Chief of the Malaria Branch at Kemri/CDC and Principal Investigator of its Phase III malaria vaccine trial said, “This is a very exciting moment, the culmination of over 30 years of intensive research on malaria vaccines. If RTS,S works as well as it has in earlier trials, its introduction could result in hundreds of thousands of lives saved.”
For 30 years, the US Centres for Disease Control and Prevention (CDC) has collaborated with the Kenya Medical Research Institute (Kemri) to fight malaria.
Prior research borne from this collaboration resulted in policy supporting the introduction of insecticide-treated mosquito nets, measures to prevent malaria in pregnancy, and improved care and treatment of those with malaria.
Dr Walter Otieno, the Principal Investigator of the vaccine trial in Kisumu-West District, noted:“This is an exciting time for Kenyans and Africa as a whole as we launch the evaluation of the world’s most advanced malaria vaccine candidate. Malaria is a very complex disease and creation of an effective vaccine has been elusive.”
Recent Phase II studies in Kenya and Tanzania showed that RTS,S reduced clinical reports of malaria by 53 per cent and has a promising safety and tolerability profile when used alongside standard infant vaccines.
Developing a vaccine against malaria is critical to defeating the disease since it would complement existing interventions, such as bed nets and effective drug therapies.
Despite current control efforts, malaria still kills close to 900,000 people globally each year, with most deaths occurring in Africa among children under the age of five.
In Kenya alone, almost 36,000 children die every year from malaria.
The Phase III trial will demonstrate how the vaccine performs in two groups of children — one aged 6-12 weeks and a second aged 5-17 months — in different transmission settings across a wide geographic region.
The study will be conducted in 11 sites in seven African countries. The various research centres selected to oversee the trial were chosen for their track record of world-class clinical research, strong community relations and commitment to meeting the highest international ethical and regulatory standards in conducting research.
This study will be the largest trial conducted in Africa of a vaccine specifically designed to help African children. We have great appreciation for the families and children participating,” said Dr Patricia Njuguna, trial Principal Investigator at Kilifi.