Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates
In-Vitro Testing of Pregnancy Malaria Vaccine Candidates
National Institute of Allergy and Infectious Diseases (NIAID)
7,476 participants
Jul 28, 2015
OBSERVATIONAL
Conditions
Summary
Background: \- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy. Objectives: \- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women. Eligibility: \- Pregnant women ages 15-25 Design: * The study site is an area in Mali, West Africa. * Participants: * Will have blood drawn. * Will give consent for the blood sample to be used for future research. * May have a physical exam. * Participants who have malaria or anemia will get treatment.
Eligibility
Inclusion Criteria4
- A study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant women aged 15-25 years
- Able to provide consent for self
- Malaria positive by rapid diagnostic test (RDT)
Exclusion Criteria3
- Severe anemia defined as HGB<7 gr/dL, that may be worsened by 10 mL phlebotomy
- Conditions that in the judgment of the investigator could increase the risk to the volunteer
- Prior enrollment to the study during the same pregnancy
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02471378