Dataset from Assessment of Safety and Immunogenicity of Intravenous Immunization With Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) in Healthy African Adults

Background:

- Malaria is caused by small germs carried by mosquitoes. People can get malaria if an
infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the
blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year.
About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to
find a safe vaccine that helps prevent malaria.

Objectives:

- To see if a new malaria vaccine is well tolerated and effective.

Eligibility:

- Healthy adults 18 35 years old who are not pregnant and live in Mali.

Design:

- Participants will be screened with medical history, physical exam, and blood test. They
will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record
the heart s electrical signals.

- Study participation will last about 1 year.

- Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ
vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses
of placebo.

- Doses will be given through a needle in the arm directly into the bloodstream. Then
participants must stay at the clinic for 2 hours.

- After each dose, participants will return to the clinic several times for blood tests
and physical exam.

- A week before the first dose and 2 weeks after the last, participants will take a full
course of anti-malaria drugs.

- If a participant gets malaria during the study, they will take another course of
anti-malaria drugs.