A Phase I clinical trial of monoclonal antibody (mAb) CIS43LS against malaria has started the enrolment of healthy adults at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, US.
The study is funded by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). It is designed to enrol up to 73 participants aged 18 to 50 with no history of malaria.
The majority of participants will be exposed to mosquitoes carrying the malaria parasite at the Walter Reed National Military Medical Center following the administration of CIS43LS.
CIS43 was observed to be effective in two different mouse models of malaria infection. The aim is to determine the ability of the drug candidate to protect from malaria infection in humans.
NIAID director Anthony Fauci said: “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.
“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.”
During the Phase I trial, one group will be administered with a single subcutaneous dose of CIS43LS at 5mg/kg of body weight. Other participants will be given a single intravenous dose at 5mg/kg, 20mg/kg, or 40mg/kg of their body weight.
Apart from safety, effectiveness and tolerability, the trial will track the blood levels of CIS43LS related to protection against malaria.
For clinical use, CIS43LS was manufactured by the NIAID’s Vaccine Research Center Vaccine Production Program and the NIAID-funded Vaccine Clinical Material Program of Leidos Biomedical Research. This is part of a contract to the Frederick National Laboratory for Cancer Research at the National Cancer Institute.
In last April, NIH launched a Phase I study of universal influenza vaccine candidate H1ssF_3928.