Structures put in place to support vaccine use in Africa

A local and international taskforce has been set up in preparation for the licensure and use of the experimental RTS,S malaria vaccine being tested in Ghana and across Africa. In Ghana, the local task force is made up of several bodies, such as the National Malaria Control Programme, the World Health Organization, (WHO) as well as Investigators working on the vaccine, epidemiologists and the managers of the Expanded Programme on Immunization. Dr Kweku Poku Asante, a Principal Investigator at the Kintampo Health Research Centre (KHRC), in the Brong Ahafo region, who is leading the trial into the RTS,S vaccine, said a similar task force had been set up internationally by the WHO for the count down towards the licensure and use of the vaccine. This is to cut down on the time between the conclusion of the study, licensure and use of the vaccine. Dr Asante was speaking to the GNA in Kintampo after the launch of a phase three studies at KHRC. It is the final trial that would see the licensure and use of the RTS,S malaria vaccine to control malaria in Africa. A 150 million dollar facility has been set aside for the phase three studies that would see some 16,000 children in Africa vaccinated and followed to determine the efficacy of the RTS,S vaccine and the ability of the vaccine to prevent malaria and its severe form in children. If the trial proves that the experimental vaccine works, and that it can be given along with vaccines in the Expanded Programme on Immunization, then it might become part of routine vaccines given to children in Africa. The trial is being sponsored by the Gates Foundation through the Malaria Vaccine Initiative of the United States. Dr Asante said the Gates Foundation and the Malaria Vaccine Initiative were in touch with the producers of the RTS,S vaccine, GSK Biological in Belgium, to ensure that the vaccines were readily available, once it is licensed for use. He said regulatory bodies, such as the United States Food and Drugs Administration and the European Drugs regulators were working with the researchers to ensure that they conformed to set standards. The Kintampo Health Research Centre is overseeing the vaccination of 1,200 children out of the 16,000. Eleven sites in Ghana, Kenya, Tanzania, Gabon, Malawi, Mozambique and Burkina Faso are taking part in the phase three studies. It is expected that results that are required to be presented to regulatory bodies would be available by 2011. A phase two study, which focused on the safety profile of the vaccine, has ended successfully and the phase three, is a pre-licensure stage being conducted in a large number of children aged 5-17 months and 6-12 weeks. The trials are being run under a project, the Malaria Clinical Trials Alliance (MCTA), established with a 17 million dollar facility from the Gates Foundation to conduct clinical trials of new drugs and vaccines to fight malaria. The School of Medical Sciences and the Kumasi Centre for Collaborative Research of the Kwame Nkrumah University of Science and Technology is one other site in Ghana conducting the phase three trials. In Kenya, three sites at Siaya, Kombewa and Kilifi, are among the eleven sites across Africa undertaking the phase three study. Already, the trial site in Kombewa has began vaccinating over 200 children since August this year under the phase three studies,. In total, the three sites in Kenya would work with about 1,000 children in the studies. Meanwhile, GSK Biologicals, as part of efforts to begin rolling the vaccines once it is licensed, has established a vaccine manufacturing plant to help make the vaccines available. The RTS,S vaccine was created in 1987 and has been developed by GlaxoSmithKline (GSK) Biologicals in close collaboration with the Walter Reed Army Institute of Research in the United States. In earlier studies, the vaccine has been shown to be safe in adults in the United States, Belgium and Kenya and among children in Mozambique.