Kenya could have its first malaria vaccine by 2015, according to researchers at Kenya Medical Research Institute and the Centres of Disease Control. The third phase of RTS,S the world’s most clinically advanced malaria vaccine candidate began last year.
It targets two groups of children — one aged 6-12 weeks and the second aged 5-17 months — in different transmission settings across a wide geographic region. According to researchers at Kemri/CDC office in Kisumu, the first vaccine introduction could take place in three-five years.
“If the vaccine is proved to be effective in the prevention of malaria, it will be introduced as part of the routine child vaccination series in Kenya by 2015,” said Dr Simon Kariuki, the principal researcher at the Kemri/CDC. Also known as Mal 55 Study, the vaccine trials began in 2009 with the mandatory preliminary duties that precede the actual study.
In July last year, Kemri/CDC began the enrolment of children into the Mal 55 Malaria Vaccine Study. So far, the enrolment for the 5-17 month age group has been completed with 800 children having been enrolled. “There is hope to have a first indication of how well the vaccine works in the older age group of children in approximately a year and a half.”
The second phase of the enrolment, which covers the younger age group of 6-12 weeks, has already begun. This targets 1,050 children and will continue for approximately one year. Dr Kariuki said that participation was voluntary. The vaccine trials are taking place in 11 sites in seven countries — Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.
In all these locations, more than 8,000 children have been enrolled into the study. At all the 11 sites RTS,S is the first vaccine designed primarily for use in Africa, where malaria kills more than 800,000 people annually, the majority of them children under the age of five. “By conducting the trials in seven different countries across sub-Saharan Africa, researchers will be able to evaluate the vaccine candidate’s efficacy in a variety of settings, with diverse patterns of malaria transmission,” said Dr Kariuki.
For example, some trial sites are located in areas where there is an all-year threat of malaria, while others experience only seasonal transmission. If the Phase III programme turns out as expected, RTS,S could be submitted for regulatory review as early as 2012 under Article 58 of the European Medicines Agency (EMEA).
Article 58 is a provision for a special review procedure that allows EMEA, in close collaboration with the World Health Organisation, to issue a scientific opinion regarding the quality, the efficacy and the safety of a medical product that is intended for use exclusively outside the European Union.
Under current plans, the RTS,S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age. Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available.
“Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years,” said Dr Kariuki. 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.
For 30 years, the CDC has collaborated with 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.
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. Research into a viable vaccine is particularly good news to Kenya where almost 36,000 children die every year from malaria and about eight million outpatient malaria treatments are recorded at health facilities, according to the division of malaria control in the Ministry of Public Health.
Malaria poses an enormous health and economic burden in Kenya, being a leading cause of morbidity and mortality, the department added. In November 2009, the government launched the National Malaria Strategic Plan 2009 – 2017, an integrated programme of controlling malaria that includes mosquito net distribution as well as treatment.
It was developed in line with the government’s Vision 2030 and the Millennium Development Goals, as well as Roll Back Malaria global partnership. The strategy also builds on the achievements and challenges of the 10-year 2001–2010 National Malaria Control Programme.
Kemri/CDC is also enlightening communities on the importance of taking other proven precautions in the fight against malaria. Dr Kariuki said there was need to keep using insecticide treated nets, preventive treatment of malaria in pregnancy, draining stagnant water and using the right Artemether-Lumefatrine (AL) drugs to treat the disease when prevention fails.
Dr Kariuki said that some parents chose to treat their children at home or ignored the disease which in turn invaded the lymph nodes of the child and caused Burkett’s Lymphomas. Burkett’s Lymphomas cause the lymph nodes of the child to swell, causing a cancerous growth mainly in the cheeks of the child.
“The condition can be prevented by diagnostic treatment of malaria but at some stages, the condition becomes terminal. This is the reason we always recommend that a child is treated well,” he added. The research institutions are also using 360 homes with more than 1,500 residents in Uyoma village in Kisumu East District to evaluate if the use of treated net curtains will help in the fight against malaria. The nets are put around the houses in places where the mosquitoes are likely to enter.