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.
GNA