As the Ebola outbreak in the Democratic Republic of the Congo (DRC) grew by six cases today, early data show that mAB114, a monoclonal antibody treatment for the disease, is safe and well-tolerated in adults, according to the results from the first human trial of the drug published today in The Lancet.
Derived from the blood of a person who survived an Ebola infection in 1995, mAB114 is an antibody that in earlier studies provided full protection against Ebola in animals, including non-human primates.
Study involved 18 adults
The phase 1 study conducted by researchers from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), looked at how infusions of mAB114 performed in 18 healthy adults ages 18 to 60 who were divided into three groups: 3 (17%) were given 5 milligrams per kilogram (mg/kg) of mAb114, 5 (28%) were given 25 mg/kg, and 10 (55%) were given 50 mg/kg.
No adverse events were reported, and no fevers were associated with infusions at any dose. Four participants reported mild reactions in the 3 days following administration of the drug, all of which resolved within 1 to 4 days.
The authors said mAB114 is the only current Ebola treatment in testing or development derived from a human survivor of the virus, and the single infusion dosing of the antibody makes it an attractive treatment in an outbreak environment. The medicine also comes in a reconstituted powder formulation that does not require refrigeration.
"The pharmacokinetic profile of mAb114 shows dose-dependent linearity, low variability between participants within a given dose, and is consistent with the pharmacokinetic profile of non-human primates receiving protective antibody doses," the authors concluded.
On Aug 10, 2018, the DRC government received mAb114 for compassionate use as a single-infusion intravenous dose of 50 mg/kg.
mAb114 is also one of three therapies being administered as part of a randomized controlled trial that began in November 2018 in the DRC comparing mortality rates among recipients of ZMapp, mAB114, and the antiviral drug remdesivir.
Six more cases in Katwa
In its daily update, officials from the DRC confirmed 6 new cases in the ongoing outbreak in North Kivu and Ituri provinces. Outbreak totals now stand at 721, including 446 deaths. A total of 204 cases are still under investigation.
All of the newly confirmed cases originated in Katwa, a hot spot of activity in recent weeks. Three new deaths were also reported in Katwa, including 2 community deaths, which occur outside of Ebola treatment centers or hospitals and raise the risk of disease spread.
The DRC said 66,861 people have been vaccinated with Merck's unlicensed Ebola vaccine as of today, including 20,183 in Beni, 15,243 in Katwa, and 7,494 in Butembo.
Yesterday, the World Health Organization (WHO) released a statement on the outbreak and shared worrisome details on the high percentage of cases in Katwa that occur among people not known to have contact with Ebola patients.
"Of the 148 cases reported in Katwa to date, less than half (55/148) were registered as contacts at the time of illness onset. Moreover, 10% (14/148) of these cases comprised of healthcare workers, and among those with available information, 42% (45/107) reported having attended a funeral in the weeks prior to illness onset," the WHO said.
"Collectively, these figures suggest that the observed increase in Katwa is being driven by a combination of both healthcare facility and community-based transmissions."
Sixty-one healthcare workers have been infected to date, the WHO said.
Jan 25 Lancet study
Jan 25 Lancet commentary
Jan 25 NIH press release
Jan 25 DRC update
Jan 24 WHO update