The third phase trial of the world most clinically advanced
malaria vaccine candidate, known as RTS, has been carried out in Kenya.
The first dose was administered at the
Siaya District Hospital recently 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, 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 worlds
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, 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.
Each country involved in the trial has
undertaken independent reviews to ensure the trial meets national safety,
ethical, and legal standards for medical research.
In addition, there is an independent data and
safety monitoring board for the full trial and a local safety monitor will
govern each site.
