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A healthy volunteer receives an intravenous injection of mAb114 – an experimental treatment for Ebola virus disease – at a Phase 1 clinical trial organized at the NIH Clinical Center in Bethesda, Maryland. Credit: NIAID
The experimental treatment mAb114, an experimental treatment against the Ebola virus, is safe, well tolerated and easy to administer, according to the findings of an early-stage clinical trial published in The lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, New Caledonia. Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of the NIH, developed the experimental treatment and conducted and sponsored the clinical trial.
Experimental treatment is currently offered to patients with Ebola virus disease in the Democratic Republic of Congo (DRC) as part of compbadionate use and as part of a phase 2/3 multi-treatment clinical trial experimental. MAb114, a unique monoclonal antibody, binds to the main receptor binding domain of Zaire's Ebaïavirus surface protein, thus preventing the virus from infecting human cells. Scientists have isolated the antibody of a human survivor of the 1995 Ebola outbreak in Kikwit, DRC. Previous studies have shown that mAb114 can protect monkeys against the deadly disease caused by the Ebola virus when it is administered up to five days after infection.
Participants in the Phase 1 clinical trial received a single intravenous infusion of mAb114 administered in approximately 30 minutes. Three participants received a dose of 5 milligrams (mg) / kilogram (kg); five participants received a dose of 25 mg / kg; and 10 participants received a dose of 50 mg / kg. All infusions were well tolerated. Four participants reported mild side effects, such as discomfort, muscle or joint pain, headache, nausea, and chills, within three days of infusion.
As expected, the levels of mAb114 in the blood increased with the increase in dosage. The researchers also observed relatively consistent levels of absorption, distribution and elimination of mAb114 among participants.
The authors highlight several advantages of the deployment of mAb114 in the event of an epidemic, in particular the ease and the speed of its administration, as well as its formulation in the form of freeze-dried powder not requiring storage in the freezer. The powder is reconstituted with sterile water and added to saline for administration.
In addition to the current phase 2/3 clinical trial on mAb114 in the DRC, the CRV is planning to launch another phase 1 trial of the experimental treatment in Africa.
NIH starts testing Ebola treatment as part of a preliminary trial
M. Gaudinski et al. Safety, tolerability, pharmacokinetics and immunogenicity of mAb114 monoclonal antibody targeting the Ebola virus glycoprotein (HRV 608): an open-label phase 1 study. The lancet DOI: 10.1016 / S0140-6736 (19) 30036-4 (2019).
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NIH / National Institute of Allergy and Infectious Diseases
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Experimental monoclonal antibodies used to treat Ebola are safe for adults (January 25, 2019)
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