Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)

Safety using a composite of adverse maternal and birth outcomes

Background:
 
 Malaria is a disease that affects many people in Africa. It is caused by germs carried by
 some mosquitoes. A person bitten by an infected mosquito will get malaria. Most malaria
 infections cause only mild symptoms or none at all, but sometimes the disease can be deadly.
 Malaria can also harm pregnant women. They may lose their pregnancies or deliver too early,
 and the mother and newborn may die. An experimental malaria vaccine (PfSPZ) has shown some
 protection against malaria infection. It is not yet known if PfSPZ is safe for pregnant
 women.
 
 Objective:
 
 To test the PfSPZ vaccine in pregnant women.
 
 Eligibility:
 
 Healthy women aged 18 to 34 years at 14 to 32 weeks gestation with 1 fetus.
 
 Design:
 
 The study will be in Mali. Participants will have about 40 clinic visits over 20 months.
 
 They will be screened. They will have an ultrasound exam and a test of their heart function.
 They will have blood and urine tests.
 
 Participants will receive an injection through a needle into a vein on 3 visits over 1 month.
 Some will receive the PfSPZ vaccine; others will be injected with salt water. They will not
 know which injection they are getting.
 
 After the last injection, participants will visit the clinic every 2 weeks. They will have
 blood tests at each visit.
 
 After giving birth, participants and their infants will visit the clinic every 2 weeks for 4
 months; then they will have visits each month until the infant is 1 year old. The infant will
 be examined and will have blood tests at each visit.