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"Malaria is still the main cause of illness and death in many regions of the world, especially infants and young children; therefore, new tools are needed to prevent this deadly disease
According to data from the World Health Organization, an estimated 229 million cases of malaria occurred globally in 2019, resulting in approximately 409,000 deaths, mainly children in sub-Saharan Africa
Malaria is caused by Plasmodium, which is transmitted to humans through the bite of an infected mosquito
Laboratory and animal studies have shown that antibodies can prevent malaria by neutralizing the sporozoites of Plasmodium falciparum in the skin and blood, preventing them from infecting liver cells
CIS43LS is extracted from a natural neutralizing antibody called CIS43
After CIS43LS has achieved promising results in an animal study for malaria prevention, VRC researchers conducted a phase 1 clinical trial on 40 healthy adults aged 18 to 50 who have never had malaria or been vaccinated.
In the first half of the trial, the research team gave 21 participants a dose of CIS43LS by intravenous infusion or subcutaneous injection
In the second half of the trial, the 6 participants who received intravenous injections during the first half of the trial continued to participate
All participants in the second half of the trial provided informed consent, agreeing to be exposed to malaria parasites in a controlled human malaria infection (CHMI)
Nine participants receiving CIS43LS and six control participants voluntarily received CHMI and were closely monitored for 21 days
Of the 9 participants who received CIS43LS, 7 received CHMI treatment approximately 4 weeks after the injection
To build on this discovery, Mali is conducting a larger Phase II clinical trial to evaluate the safety and effectiveness of CIS43LS in preventing adult malaria infection during the 6-month malaria season
In addition, VRC scientists are conducting further research on CIS43LS in the United States to determine the minimum dose to protect people from malaria infection
Dr.
For more information about completed Phase 1 clinical trials, please log on to ClinicalTrials.
References: MR Gaudinski et al
Journal Reference :
Martin R.
Gaudinski, Nina M.
Berkowitz, Azza H.
Idris, Emily E.
Coates, LaSonji A.
Holman, Floreliz Mendoza, Ingelise J.
Gordon, Sarah H.
Plummer, Olga Trofymenko, Zonghui Hu, Andrezza Campos Chagas, Sarah O&rsquo ;Connell, Manjula Basappa, Naomi Douek, Sandeep R.
Narpala, Christopher R.
Barry, Alicia T.
Widge, Renunda Hicks, Seemal F.
Awan, Richard L.
Wu, Somia Hickman, Diane Wycuff, Judy A.
Stein, Christopher Case , Brian P.
Evans, Kevin Carlton, Jason G.
Gall, Sandra Vazquez, Britta Flach, Grace L.
Chen, Joseph R.
Francica, Barbara J.
Flynn, Neville K.
Kisalu, Edmund V.
Capparelli, Adrian McDermott, John R .
Mascola, Julie E.
Ledgerwood, Robert A.
Seder.
A Monoclonal Antibody for Malaria Prevention .
New England Journal of Medicine , 2021; DOI: 10.
1056/NEJMoa2034031