Background:
People get malaria when they are bitten by an infected mosquito. Malaria can be serious and
sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that
fully prevents infection. Researchers want to test if an experimental drug can help.
Objective:
To test a drug called CIS43LS that could prevent malaria infection.
Eligibility:
Healthy people ages 18-50 who have never been infected with malaria
Design:
Participants will be screened with a physical exam, blood tests, and medical history.
Some participants will get pregnancy tests.
Most participants will get CIS43LS. They will get the drug infused into a vein in their arm
or injected into the fat under the skin. They will be monitored for side effects for up to 4
hours after they get the drug.
Participants will be given a thermometer to check their temperature every day for 7 days.
They will also be given a device to measure any redness, swelling, or bruising at the
injection site.
Participants will have up to 12 follow-up visits. These will include blood tests.
Most participants will take part in a Controlled Human Malaria Challenge (CHMI). During the
CHMI, mosquitoes carrying the malaria parasite will bite participants in a controlled
setting. The participants will then have clinic visits every day for up to 12 days starting 7
days after the CHMI. They will be treated right away with antimalarial medication if the test
shows positive for malaria. If participants continue to test negative for malaria, they will
have 2 more visits over the next 6 days for blood tests. Then 28 days after the CHMI they
will get treated with antimalarial medication for 3 days. The study will last 2-6 months
depending on participants study group....
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)