Trial to Evaluate CIS43LS in Healthy Adults

Study Summary

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 the safety and effectiveness of a drug called CIS43LS that could prevent malaria infection. Eligibility: Healthy people ages 18-50 who have never been infected with malaria Design: Participants were enrolled on the basis of eligibility criteria, evaluated by clinical laboratory tests, self-reported medical history, and physical examination. Participants received CIS43LS either infused into a vein in their arm or injected into the fat under the skin. They were monitored for side effects for up to 4 hours after they received the drug. Participants received a thermometer and recorded their temperature and symptoms every day on/with/via a diary card for 7 days after administration. The administration site was checked for redness, swelling, itching or bruising. Participants had up to 12 follow-up visits. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Most participants who received CIS43LS took part in a Controlled Human Malaria Infection Challenge (CHMI) along with control participants who did not receive CIS43LS. During the CHMI, mosquitoes carrying the malaria parasite bit participants in a controlled setting. The participants had clinic visits every day for up to 12 days starting 7 days after the CHMI. Participants were treated right away with antimalarial medication if they tested positive for malaria. Approximately 21 days after the CHMI, participants were treated with antimalarial medication for 3 days. The study lasted 2-6 months depending on the participant's study group.

Primary Outcome

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogen

Conditions Studied

Interventions

• DRUG VRC-MALMAB0100-00-AB
• OTHER Plasmodium falciparum (P. falciparum) sporozoite challenge

Study Locations (2)