NIAID Launches Malaria Vaccine Trial in Africa
Source: NIH/National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases
(NIAID), one of the National Institutes of Health, has reached a
milestone in its efforts to support accelerated development of
malaria vaccines. Working with an international group of public
and private partners, NIAID has launched its first trial of a
candidate malaria vaccine in a country where malaria is endemic.
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 ar-
eas, research centers that can support the complex clinical de-
velopment 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 mil-
lion 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 ma-
laria vaccine. In addition to NIAID and the University of Bamako,
the collaborators include the University of Maryland at Balti-
more; NIAID's Malaria Vaccine Development Unit; the Malian Minis-
tries 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 devel-
oped 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 vac-
cine. 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 analyz-
ing the immune responses against the Plasmodium falciparum ma-
Contact: Laurie Doepel
NIH/National Institute of Allergy and Infectious Diseases
Dr Rana Jawad Asghar
Program Manager Child Survival, Mozambique
Provincial Coordinator Sofala Province, Mozambique
Health Alliance International, Seattle, WA, USA
Coordinator South Asian Public Health Forum
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