The National Institute of Allergy and Infectious Diseases (NIAID) has launched its first trial of a candidate malaria vaccine in a country where malaria is endemic. NIAID has reached a milestone in its efforts to support accelerated development of malaria vaccines. The Phase I trial, taking place in Mali, seeks to confirm the safety and immunogenicity in adults of a candidate vaccine called FMP-1.
A key component of the NIAID Plan for Research for Malaria Vaccine Development has been to establish, in malaria-endemic areas, research centers that can support the complex clinical development of malaria vaccines. Conducting a malaria vaccine trial in Africa is important because more than 90 percent of malaria deaths occur in Africa, and the great majority of these deaths are in young children. Each year, malaria infects an estimated 300 to 500 million people worldwide and causes more than 1 million deaths, according to the World Health Organization.
This trial, the first to be conducted by Malian researchers from the Malaria Research and Training Center in the Department of Epidemiology of Parasitic Diseases at the Medical School of the University of Bamako, is taking place in Bandiagara, Mali, with NIAID support. It reflects the result of many years of effort by a group of organizations dedicated to creating an effective malaria vaccine.
In addition to NIAID and the University of Bamako, the collaborators include the University of Maryland at Baltimore; NIAID's Malaria Vaccine Development Unit; the Malian Ministries of Health and Education; the Walter Reed Army Institute of Research (WRAIR); GlaxoSmithKline Biologicals (GSK); the U.S. Agency for International Development (USAID); and the World Health Organization (WHO).
Developed by WRAIR in collaboration with GSK Biologicals, and with support from USAID, the FMP-1 vaccine has already proved safe and immunogenic in two small Phase I and Phase IIa studies in the United States and an additional Phase I study in Kenya. The vaccine contains an experimental adjuvant called AS02A developed by GSK and intended to enhance the immune response.
The trial will enroll 40 adults between the ages of 18 and 55. Half of the volunteers will receive the malaria vaccine and half will serve as a control group by receiving a licensed rabies vaccine. Each volunteer will receive three injections over two months, and the researchers will follow each volunteer for one year, monitoring the long-term safety of the vaccine and analyzing the immune responses against the "Plasmodium falciparum" malaria parasite.