Experimental Vaccine for Malaria in Adults in Mali
Status:
Completed
Trial end date:
2008-01-22
Target enrollment:
Participant gender:
Summary
This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can
safely be given to adults exposed to malaria. Malaria affects about 300 million to 500
million people worldwide each year, causing from 2 million to 3 million deaths, mostly among
children under 5 years of age in sub-Saharan Africa. It is the leading cause of death and
illness among the general population of Mali in West Africa. Increasing drug resistance to
the malaria parasite, as well as widespread resistance of mosquitoes (the insects that
transmit the parasite) to pesticides are reducing the ability to control malaria through
these strategies. A vaccine that could reduce illness and death from malaria would be a
valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine
developed by the NIAID. Early tests of AMA1-C1 in 30 healthy people in the United States
found no serious harmful side effects of the vaccine. This study will look at the effect of
AMA1-C1 in people in Mali who have been exposed to malaria.
Residents of Don gu bougou, Mali, who are between 18 and 45 years of age and are in general
good health may be eligible for this study. Candidates are screened with a medical history
and physical examination, blood and urine tests, and urine pregnancy test for women.
Participants are randomly assigned to receive three injections (shots) of either the
experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali. All
shots are given in an upper arm muscle. After the first shot, the second is given 1 month
later, and the third is given 12 months after the first. Subjects receiving AMA1-C1 will get
one of three different doses - low, medium, or high - to find the dose that is safest and
gives the best antibody response to the vaccine. After each shot, participants remain in the
clinic for 30 minutes for observation. They return to the clinic 1, 2, 3, 7, and 14 days
after each shot for a physical examination and to check for side effects. Blood samples are
drawn before each shot and at selected return clinic visits to check for side effects and to
measure the effect of the vaccine.
During the rainy seasons after the second and third vaccinations, subjects come to the clinic
once a month for an examination and a blood test. During the dry season, subjects come to the
clinic 3 months before the last shot is given for an examination and blood test. Additional
blood tests may be done on participants who develop malaria.
If found to be safe in adults, further studies with this vaccine will be done in children
exposed to malaria, as it is children who bear the brunt of this disease.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)