Intravenous immunization with PfSPZ Vaccine in healthy African adults

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.

Eligibility: Healthy adults 18 to 35 years old who are not pregnant and live in Mali.

Design:
Participants will be screened with a 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 exams.
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.

Study type: Interventional
Enrollment: 296 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Factorial assignment
Masking :Double (participants, investigator)
NCT number: NCT01988636
Phase: Phase I

Clinical trial registrationProject details

Vaccines

Oct 2013 — Aug 2015

$451,901

Mali