Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites in Healthy African Adults in Mali

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2015
Background: Malaria is still a health problem in Sub-Saharan Africa. Death rates are stable and have even increased in some areas. There are malaria vaccines. However, researchers think repeated immunizations with a vaccine called PfSPZ may work better. Objective: To see if PfSPZ is safe, tolerable, and effective against malaria. Eligibility: Healthy adults ages 18 to 50 years who live in the Doneguebougou area in Mali Design: Participants will be screened with medical history and physical exam. Participants will sign or fingerprint the consent form. They will take a survey to see how well they understand the study. Participants will give blood and urine samples. Participants will have at least one ECG: Soft electrodes will be stuck to the skin. A machine will record heart signals. Participants will have HIV counseling. Participants will be assigned to a group. Groups will get a different strength doses. Groups will get a different number of vaccines over different periods of time. If a participant develops a rash or injection site reaction, photographs may be taken. Participants will receive an oral anti-malaria drug during the study. Participants will be monitored for 3 to 6 months after the last vaccine.
Epistemonikos ID: 68963d2850eaf5cd22174e98b21206a1116dc5e3
First added on: May 12, 2024