VRC 614: A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0114-00-AB (L9LS), in Heal

• Status: Recruiting
• Trial end date: 2022-12-31

Summary

Background:

Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly. Researchers want to test a drug to prevent malaria.

Objective:

To test if the drug L9LS is safe and if it prevents malaria infection in people.

Eligibility:

Healthy adults ages 18-50 who have never had malaria.

Design:

Participants will be screened with a medical history, physical exam, and blood tests.

Participants will be divided into 5 groups:

• Three groups will get L9LS by infusion into a vein. They will give blood samples before and after infusion.

• One group will get L9LS injected into the fat under the skin.

• One group will not get L9LS.

All participants who get L9LS will be monitored for side effects. They will have 2-3 follow-up visits during the week after the drug is given. They will give blood samples. They will get a thermometer to check their temperature daily for 7 days. They will get a tool to measure any redness, swelling, or bruising at the injection site.

All participants will be bitten by mosquitoes carrying the malaria parasites. A cup containing mosquitoes will be placed on their arm for 5 minutes. On days 7-17 after exposure, they will have daily study visits to give blood samples. Those who get malaria will be treated immediately. On day 21, all participants will get treatment for malaria.

Participation will last 2-6 months, depending on study group.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)