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

• Status: Completed
• Trial end date: 2018-07-03

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artemether, Lumefantrine Drug Combination; Vaccines