National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2008-08-11
This study will evaluate the safety and immune response of children to an experimental
malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an
infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by
certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with
more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan
Africa. Malaria is the leading cause of death and illness among the general population of
Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of
mosquitoes to pesticides are reducing the ability to control the disease through these
strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It
is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work
better.
Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good
health may be eligible for this study. Candidates are screened with a medical history,
physical examination, and blood and urine tests.
Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a
control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given
in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed
in the clinic for 30 minutes. They return to the clinic for a physical examination six or
seven times between each shot and then four more times over a 9-month period after the last
shot. Blood samples are drawn at several of these visits to check for side effects of the
vaccine and to measure the response to it. The total duration of the study is 21 months.
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