PROMISING MALARIA VACCINE CANDIDATE UNDERGOES STUDY IN KINTAMPO

Kintampo, Ghana—Scientists from the Kintampo Health Research Centre (KHRC), Ghana Health Service, Ministry of Health have begun a field trial to assess the immunological impact and safety of a malaria vaccine candidate in young children. The Director of KHRC Dr. Seth Owusu-Agyei, The Brong-Ahafo Regional Director of Health Services, Alhaj Dr. Mohammed Bin Ibrahim and others briefed reporters today about the long-term need for a vaccine to combat malaria and details about the trial.

The trial is being conducted at two sites in Ghana—in Kintampo by KHRC, and in Agogo by KCCR/SMS—to study a promising malaria vaccine candidate known as RTS,S.

RTS,S has been in active development since 1987. Early development of RTS,S was undertaken by GlaxoSmithKline (GSK) Biologicals, the vaccine division of GSK, in close collaboration with the Walter Reed Army Institute of Research (WRAIR). In January 2001, GSK Biologicals and the PATH Malaria Vaccine Initiative (MVI) entered into an agreement to develop the vaccine for infants and young children living in sub-Saharan Africa. The Ghanaian trials are part of a rigorous process aimed at validating the efficacy and safety of the vaccine.

The two Ghanaian sites are recruiting 540 children, ages 5-17 months to participate. The vaccine has shown to be safe in studies conducted on adult volunteers in the United States, Europe, The Gambia, and Kenya, and in children in The Gambia and Mozambique. Results from the Mozambique study, in which 2,000 children participated, showed the vaccine to be effective for at least 18 months in reducing clinical malaria by 35 percent and severe malaria by 49 percent.

“Every Ghanaian knows the heavy toll malaria takes on people and society, particularly the children,” says Dr. Owusu-Agyei. “More than a million people in sub-Saharan Africa die from malaria each year. In 2003, more than three and a half million malaria cases were reported in this country alone. We know that immunization is the most effective way to control infectious diseases, so an effective malaria vaccine would represent a huge step forward in combating this terrible disease.”

“This trial in Ghana is particularly significant, as we will be looking more closely at vaccine formulations and the scheduling of vaccinations,” continued Dr. Owusu-Agyei. He stressed, however, that even if the trial is successful, several more years of work will be needed before the vaccine is ready to make its way to the nation’s children. If all goes well, the vaccine could be submitted to regulatory authorities as early as 2010. Thereafter, it would need to be recommended by policymakers, and finally, plans must be made and implemented for acquiring the vaccine and ensuring its widespread use.

“It is very encouraging to see the world finally become aware of the scourge of malaria and for the private and public sectors to come together to do something about it”, says Alhaj Dr. Mohammed Bin Ibrahim, The Brong-Ahafo Regional Director of Health Services. “We are grateful for these efforts and for the opportunity to do our part in fighting malaria. We must also remember the contributions of the Ghanaian parents and children participating in the trials, and the commitment of the workers of the Kintampo Health Research Centre and the Ghana Health Service, including the doctors and researchers who are ensuring that these trials put safety first and are conducted in accordance with high international standards.”

About the Kintampo Health Research Centre

The Kintampo Health Research Centre was established in 1994 and provides a base for clinical/field epidemiological and other health research in the forest-savannah ecological and cultural transition zone of the country. Its vision is to develop and sustain a locally- and internationally-based health research and development resource centre capable of generating new knowledge and relevant information regarding priority problems in health systems at the district, national, and international levels through effective scientific research, training, and services aimed at better health and community development. For more information, visit www.ghana-khrc.org.

About the PATH Malaria Vaccine Initiative:

PATH is an international, non-profit organization that creates sustainable, culturally relevant solutions enabling communities worldwide to break longstanding cycles of poor health. For more information, visit www.path.org. The PATH Malaria Vaccine Initiative (MVI) is a global program established through an initial grant of US$50 million from the Bill & Melinda Gates Foundation, which has since awarded it an additional $207.6 million, including $107.6 million to complete development of the RTS,S vaccine. MVI’s mission is to accelerate the development of promising malaria vaccines and ensure their availability and accessibility for the developing world. For information, visit www.malariavaccine.org.

About GlaxoSmithKline and GlaxoSmithKline Biologicals

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day. GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information please visit: www.gsk.com.

For more information, contact Dr. Seth Owusu-Agyei (Tel office: +233 61 2415; Tel mobile: +233 24 4560213)