On World Malaria Day 2010, the international community marks a historic milestone in the fight against malaria. This past year, we launched a Phase III efficacy trial of the world's most advanced malaria vaccine candidate in 11 research centers spanning seven African countries. Phase III is the last big step for a vaccine candidate before submission for approval to regulatory authorities.
Malaria takes a devastating toll on communities in Africa. In Ghana, like many African countries, malaria is the one of the most deadly diseases for children under the age of five. To be sure, we will need to use every tool available, including bed nets, indoor residual spraying and drugs, to fight this disease. A vaccine would complement existing interventions and has the potential to save hundreds of thousands of lives.
When I began my studies in malaria research 15 years ago, I never dreamed I would be doing this work today. My colleagues and I never thought we would play a part in the development of a malaria vaccine or that we would come this far.
Back then, no vaccine candidate had shown efficacy in protecting against malaria. Research centers in Africa were not collaborating to conduct large vaccine trials and there were few international partnerships pursuing malaria vaccine research.
This has all changed because many people never lost hope. Today, the once unimaginable is a near reality, and a malaria vaccine is within our reach.
RTS,S, as the candidate is known, has been in development for more than 20 years, including a decade of clinical research in Africa. Trial results have consistently shown that the vaccine candidate has a promising safety profile and could reduce the risk of malaria by half, in children. In clinical studies, the vaccine candidate demonstrated that it can also be used alongside other vaccines given routinely to infants, such as vaccines for measles, tetanus, diphtheria and polio.
Today, the trial is well underway in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The vaccine candidate is the first designed specifically for use in Africa, and it aims to protect children from the disease. To date, more than 8,500 children and infants have already been enrolled in the trial, of the projected 16,000 participants.
Recently, I became co-chair of the Clinical Trials Partnership Committee, the group of leading African research institutions that, together with GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative, manages the RTS,S clinical trials across the seven countries. To be selected for the trial, the research centers needed to have track records of world-class clinical research that met international safety and ethical standards. At my institute and others in this trial, we increased our capabilities by building new facilities, installing sophisticated laboratory equipment and training our staff to use the latest technologies. Now, many of our research institutions are even stronger, and we are attracting bright young talent to our research work.
We have other partners as well, and they are critical. Our research sites work hand-in-hand with families, local leaders and educators to ensure that the trial is conducted safely, ethically and with the full support and understanding of all those involved. Since the trial began, I have been humbled by the dedication of the families who share our vision and are joining us in this effort to defeat a deadly foe.
Going forward, we must continue to collaborate across sectors and borders to ensure that the vaccine reaches those who need it most, as soon as possible after it is approved. Although we must wait until the trial data is analyzed and regulators make their final determinations, I urge our leaders to now match our advances in research with similar advances in public health capacity and the political will required to widely implement the first ever malaria vaccine.
We can make the promise of a malaria vaccine a reality if we maintain the momentum of this Phase III trial and begin to plan now for the future.
Dr. Tsiri Agbenyega is a Principal Investigator at the Agogo Presbyterian Hospital trial site, and, former dean of the Medical School at the Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. He heads the malaria research unit at Komfo-Anokye Hospital in Ghana and is co-chair of the RTS,S Clinical Trials Partnership Committee.