The launch follows the initiation in Tanzania in May of the phase III trial, which is expected to enroll up to 16,000 children and infants in seven countries throughout Africa. GlaxoSmithKline Biologicals developed and manufactures the vaccine, and the PATH Malaria Vaccine Initiative (MVI) is providing technical and financial support for the trial.
The first dose of the investigational vaccine was administered at UNC Project-Malawi in Lilongwe, the country’s capital. Researchers at the site will recruit and enroll 1,600 children and expect the initial three-dose vaccination will completed by December.
“We are proud to be one of the sites to implement this critical study,” said Francis Martinson, M.D., Ph.D., 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 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 efforts, malaria still kills close to 900,000 people each year, with most deaths occurring in Africa among children under the age of five.
If the phase III program progresses as expected, researchers believe RTS,S could be submitted for regulatory review as early as 2011, introduced for use in children aged 5 months to 17 months in 2012, and be fully available by 2014.
UNC has been working in Malawi since 1989. UNC Project is a research, care and training facility operated by the institute in partnership with the Malawi Ministry of Health.
For more information, visit: http://globalhealth.unc.edu/malaria-vaccine-trial.php.
Institute for Global Health and Infectious Diseases contact: Lisa Chensvold (919) 843-5719, firstname.lastname@example.org