The Phase III trial of the world’s most clinically advanced malaria vaccine candidate, known as RTS,S, got underway earlier this month in Lilongwe, Malawi. The first dose of this investigational vaccine was administered at UNC Project-Malawi under the auspices of the Institute for Global Health & Infectious Diseases at UNC.
The launch follows the initiation of the Phase III trial in Tanzania in May 2009. GlaxoSmithKline Biologicals developed and manufactures the vaccine, and the PATH Malaria Vaccine Initiative (MVI) is providing technical and financial support for the trial, which is expected to enroll up to 16,000 children and infants in six other countries throughout Africa.
The start of the RTS,S Phase III vaccine trial in Lilongwe is viewed as a major milestone. “We are proud to be one of the sites to implement this critical study,” said Francis Martinson, MD, PhD, who is country director of UNC Project-Malawi and principal investigator on the study. “If this vaccine proves effective, it would surely be a great milestone in medicine,” Martinson said.
Tisungane Mvalo, MO, is study coordinator for the Lilongwe site. “Our daily work involves reducing the burden of infectious diseases, including malaria,” he said. “Prevention is always better than cure.”
Developing a vaccine against malaria is critical to defeating the disease. A vaccine would complement existing interventions, such as bed nets and effective drug therapies. Despite current control efforts, malaria still kills close to 900,000 people each year, with most deaths occurring in Africa among children under the age of five.
About the Phase III trial
The RTS,S Phase III trial will demonstrate how the vaccine performs in two groups of children – one aged 6-12 weeks and a second aged 5-17 months – in different transmission settings across a wide geographic region. In all, the study will be conducted in 11 sites in seven African countries. The various research centers selected to oversee the trial were chosen for their track record of world-class clinical research, strong community relations and commitment to meeting the highest international ethical and regulatory standards in conducting research.
UNC has been working in Malawi since 1989. UNC Project is a research, care and training facility operated by the Institute for Global Health & Infectious Diseases in partnership with the Malawi Ministry of Health. Operating in a two-story, 17,500 sq ft building that includes examination rooms, a state of the art laboratory and a medical library, UNC Project employs over 250 people in Malawi, conducts 20 ongoing research studies and treats well over 50,000 patients.
The Lilongwe malaria trial site will recruit and enroll 1600 children in the study. It is expected that the initial three-dose vaccination will completed by December 2009 “Being part of this trial could lead to a malaria vaccine and will potentially save millions of lives,” said Irving Hoffman, PA, MPH, U.S. director of UNC Project-Malawi and the study’s co-principal investigator. “That is a responsibility our team takes very seriously,” he said.
If the Phase III program progresses as expected, RTS,S could be submitted for regulatory review as early as 2011 and could be introduced in 2012 for children age 5 to 17 months. Full availability is anticipated by 2014.
GSK and MVI are already working with malaria-affected countries and international institutions to ensure that a successful malaria vaccine will be readily available in the places and for those who need it most.
Funding for the clinical development of this vaccine candidate has been made possible by more than US$ 100 million in grants from the Bill & Melinda Gates Foundation to MVI. GSK has invested more than $300 million to date and expects to invest at least another $100 million before the completion of the project.
Institute for Global Health and Infectious Diseases contact: Lisa Chensvold (919) 843-5719, email@example.com