The U.S. National Institutes of Health (NIH) kicked off the first human trial of a monoclonal antibody to prevent malaria.
NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced Monday that the Phase 1 clinical trial testing the safety and effectiveness of the drug called CIS43LS had begun enrolling healthy adult volunteers.
“If proven safe and effective in this study and in larger trials, this monoclonal antibody might be used prophylactically by tourists, medical workers or military personnel who travel to areas where malaria is common,” said NIAID Director Anthony Fauci.
The investigators are going to enroll up to 73 volunteers aged 18 through 50 who have never had malaria. After receiving the antibody, most of the volunteers will be exposed to malaria parasite-carrying mosquitoes under carefully controlled conditions.
“In the absence of a highly effective, long-lasting vaccine, preventing malaria infections for several months with a single dose of monoclonal antibody also could be valuable in specific parts of Africa where malaria cases increase greatly during annual rainy seasons,” said Fauci.
When tested in two different mouse models of malaria infection, the prototype of the antibody was highly effective at preventing infection by a deadliest malaria parasite. Modifications to it yielded the antibody, which lasts longer in the blood than the original antibody, according to the investigators.
In addition to acquiring data about the safety and tolerability, they will also gather data about the blood levels of this antibody that are associated with protection from malaria, which may allow investigators to determine optimum dosage levels needed to achieve clinical protection from infection.
In 2018, an estimated 228 million cases of malaria occurred worldwide, causing an estimation of 405,000 deaths, according to the World Health Organization. Enditem